@article{Baxter2025,

title = {Glucagon-Like Peptide 1 Receptor Agonists and Risk of Thyroid Cancer: An International Multisite Cohort Study},

author = {Sarah M. Baxter and Lars Christian Lund and Jacob H. Andersen and Thomas H. Brix and Laszlo Hegedüs and Miyuki Hsing-Chun Hsieh and Chris Tzu-Ting Su and Michael Chun-Yuan Cheng and Zoe Chi-Jui Chang and Edward Chia-Cheng Lai and Swaleh Hussain and Cherry Chu and Tara Gomes and Tony Antoniou and Antoine Eskander and Zachary Bouck and Mina Tadrous and Sungho Bea and Eun-Young Choi and Ju-Young Shin and Karin Modig and Mats Talbäck and Rickard Ljung and Hanne Løvdal Gulseth and Øystein Karlstad and Blánaid Hicks and Anton Pottegård},

doi = {10.1089/thy.2024.0387},

issn = {1557-9077},

year  = {2025},

date = {2025-01-01},

journal = {Thyroid®},

volume = {35},

number = {1},

pages = {69--78},

publisher = {Mary Ann Liebert Inc},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Cesta2025,

title = {In Memoriam—Helle Kieler (1956–2024)},

author = {Carolyn E. Cesta and Gabriella Bröms and Kari Furu and Sonia Hernandez‐Diaz and Krista F. Huybrechts and Olof Stephansson and Helga Zoega},

doi = {10.1002/pds.70073},

issn = {1099-1557},

year  = {2025},

date = {2025-01-00},

journal = {Pharmacoepidemiology and Drug},

volume = {34},

number = {1},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hemmingsen2025,

title = {Maternal use of hormonal contraception and risk of childhood leukemia: A Scandinavian population-based cohort study},

author = {Caroline H. Hemmingsen and Susanne K. Kjaer and Sarah Hjorth and Ulrika Nörby and Anne Broe and Anton Pottegård and Justine Bénévent and Kjeld Schmiegelow and Charlotte Wessel Skovlund and Maarit K. Leinonen and Hedvig Nordeng and Lina S. Mørch and Marie Hargreave},

doi = {10.1016/j.ejca.2024.115168},

issn = {0959-8049},

year  = {2025},

date = {2025-01-00},

journal = {European Journal of Cancer},

volume = {215},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rasmussen2024b,

title = {Treatment patterns of antidepressants in children and adolescents in Scandinavia},

author = {Lotte Rasmussen and Peter Bjødstrup Jensen and Johan Reutfors and Kari Furu and Svetlana Skurtveit and Randi Selmer and Per Damkier and Mette Bliddal and Rikke Wesselhoeft},

doi = {10.1007/s00787-024-02433-7},

issn = {1435-165X},

year  = {2025},

date = {2025-01-00},

journal = {Eur Child Adolesc Psychiatry},

volume = {34},

number = {1},

pages = {159--167},

publisher = {Springer Science and Business Media LLC},

abstract = {Abstract

          The aim of this study was to examine variations in use of antidepressants among children and adolescents in the three Scandinavian countries (Sweden, Norway, and Denmark). We identified new users of antidepressants (5–17 years) during 2007–2018 and described the annual incidence rate, treatment duration, concomitant psychotropic drug use, and the clinical setting of the prescribing physician (in Sweden and Denmark). Incident use of antidepressants increased by a factor 1.9 in Sweden, 1.3 in Norway and decreased by a factor 0.6 in Denmark during the study period. In Sweden, 58% of antidepressant users were covered by a prescription 12 months after initiation compared to 40% in Norway and 49% in Denmark. Also, 34% of Swedish antidepressant users were in continuous treatment after 12 months compared to 26% in Norway and 31% in Denmark. Concomitant use of other psychotropics was more common in Sweden (57%) than in Norway (37%) and Denmark (27%). During 2007–2018, clinicians from psychiatry settings initiated 75% of antidepressant treatments in Sweden, while this was the case for 50% of prescriptions in Denmark, although the proportion increased over time. The number of new antidepressant users is high and still rising in Sweden compared to Norway and Denmark. Swedish antidepressant users are more likely to use other psychotropics and to be covered by an antidepressant prescription after one year. Most antidepressants in Sweden are prescribed by physicians within psychiatric settings suggesting that they are based on specialized psychiatric evaluation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Vegrim2024,

title = {High‐dose folic acid use and cancer risk in women who have given birth: A register‐based cohort study},

author = {Håkon Magne Vegrim and Julie Werenberg Dreier and Jannicke Igland and Silje Alvestad and Nils Erik Gilhus and Mika Gissler and Maarit K. Leinonen and Torbjörn Tomson and Helga Zoega and Jakob Christensen and Marte‐Helene Bjørk},

doi = {10.1111/epi.18146},

issn = {1528-1167},

year  = {2025},

date = {2025-01-00},

journal = {Epilepsia},

volume = {66},

number = {1},

pages = {75--88},

publisher = {Wiley},

abstract = {AbstractObjectiveThis study was undertaken to study whether high‐dose folic acid (>1 mg daily) use is associated with an increased risk of cancer in all women who have given birth and in women with epilepsy. High‐dose folic acid supplementation during pregnancy has been linked to increased cancer risk in children born to mothers with epilepsy.MethodsWe identified women with their first pregnancy in Denmark (1997–2017), Norway (2005–2017), and Sweden (2006–2017) using medical birth registers, linking individual data across nationwide health registers and statistical agencies. Exposure was defined as filled prescriptions for high‐dose folic acid, considered time‐varyingly. The primary outcome was the first malignant cancer diagnosis. Hazard ratios (HRs) of cancer after high‐dose folic acid exposure were estimated using Cox proportional hazard models with 95% confidence intervals (CIs), adjusted for confounders including antiseizure medication (ASM) use, and stratified by maternal epilepsy diagnosis. A 6‐month time lag was applied, as cancer is unlikely to develop immediately.ResultsWith up to 21 years of follow‐up, we identified 1 465 785 women who gave birth, including 64 485 (4.4%) exposed to high‐dose folic acid. In the exposed group, 755 cancer cases were observed (208 per 100 000 person‐years, 95% CI = 193.8–223.5), compared with 18 702 cases in the unexposed group (164 per 100 000 person‐years, 95% CI = 161.5–166.2), yielding a 20% increased cancer risk overall (adjusted HR = 1.2, 95% CI = 1.1–1.2). This risk was attenuated after the 6‐month lag analysis (adjusted HR = 1.1, 95% CI = 1.04–1.2). The risk for non‐Hodgkin lymphoma was increased in all analyses (n = 28, adjusted HR = 2.0, 95% CI = 1.3–2.9). The association between high‐dose folic acid use and overall cancer risk was similar in those with epilepsy regardless of ASM use (adjusted HR = 1.3, 95% CI = 1.0–1.8).SignificanceHigh‐dose folic acid use was associated with increased overall cancer risk in women who have given birth, with a consistent association with non‐Hodgkin lymphoma, including those with epilepsy, regardless of ASM use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Wittström2024,

title = {Lithium Use During Pregnancy in 14 Countries},

author = {Felix Wittström and Carolyn E. Cesta and Brian T. Bateman and Marie Bendix and Mette Bliddal and Adrienne Y. L. Chan and Yongtai Cho and Eun-Young Choi and Jacqueline M. Cohen and Sarah Donald and Mika Gissler and Alys Havard and Sonia Hernandez-Diaz and Krista F. Huybrechts and Bianca Kollhorst and Edward Chia-Cheng Lai and Maarit K. Leinonen and Brian M. H. Li and Kenneth K. C. Man and Vanessa W. S. Ng and Lianne Parkin and Laura Pazzagli and Lotte Rasmussen and Ran S. Rotem and Tania Schink and Ju-Young Shin and Duong T. Tran and Ian C. K. Wong and Helga Zoega and Johan Reutfors},

doi = {10.1001/jamanetworkopen.2024.51117},

issn = {2574-3805},

year  = {2024},

date = {2024-12-02},

journal = {JAMA Netw Open},

volume = {7},

number = {12},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceIn pregnancy, the benefits of lithium treatment for relapse prevention in psychiatric conditions must be weighed against potential teratogenic effects. Currently, there is a paucity of information on how and when lithium is used by pregnant women.ObjectiveTo examine lithium use in the perinatal period.Design, Setting, and ParticipantsThis cohort study used individual-level data of pregnancies from January 1, 2000, to December 31, 2021, in Australia, Denmark, Finland, Germany, Hong Kong, Iceland, Israel, New Zealand, Norway, South Korea, Sweden, Taiwan, the UK, and 2 cohorts in the US. Analyses were performed from September 1 to November 30, 2023.ExposuresThe prevalence of lithium use as the proportion of pregnancies with at least 1 prescription fill or prescription within 3 months before pregnancy until childbirth was estimated using a common protocol. Lithium use during pregnancy by trimester and in the 3 months before and after pregnancy was examined.Main Outcomes and MeasuresComparison of prevalence between the first and last 3-year periods of available data.ResultsAmong 21 659 454 pregnancies from all collaborating sites, the prevalence of lithium use ranged from 0.07 per 1000 pregnancies in Hong Kong to 1.56 per 1000 in the US publicly insured population. Lithium use increased per 1000 pregnancies in 10 populations (Australia [0.60 to 0.74], Denmark [0.09 to 0.51], Finland [0.10 to 0.29], Iceland [0.24 to 0.99], Israel [0.25 to 0.37], Norway [0.24 to 0.47], South Korea [0.30 to 0.44], Sweden [0.42 to 1.07], the UK [0.07 to 0.10], and Taiwan [0.15 to 0.19]), remained stable in 4 populations (Germany [0.17 to 0.16], Hong Kong [0.06 to 0.06], and the publicly [1.50 to 1.34] and commercially [0.38 to 0.36] insured US populations), and decreased in 1 population (New Zealand [0.54 to 0.39]). Use of lithium decreased with each trimester of pregnancy, while prevalence of postpartum use was similar to prepregnancy levels. The proportion of lithium use in the second trimester compared with the prepregnancy period ranged from 2% in South Korea to 80% in Denmark.Conclusions and RelevancePrevalence of lithium use in pregnant women over the past 2 decades varied markedly between populations. Patterns of use before, during, and after pregnancy suggest that many women discontinued lithium use during pregnancy and reinitiated treatment after childbirth, with large variations between countries. These findings underscore the need for internationally harmonized guidelines, specifically for psychiatric conditions among pregnant women that may benefit from lithium treatment.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ueda2024,

title = {GLP-1 Receptor Agonist Use and Risk of Suicide Death},

author = {Peter Ueda and Jonas Söderling and Viktor Wintzell and Henrik Svanström and Laura Pazzagli and Björn Eliasson and Mads Melbye and Anders Hviid and Björn Pasternak},

doi = {10.1001/jamainternmed.2024.4369},

issn = {2168-6106},

year  = {2024},

date = {2024-11-01},

journal = {JAMA Intern Med},

volume = {184},

number = {11},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceConcerns have been raised regarding a link between use of glucagon-like peptide-1 (GLP-1) receptor agonists and increased risk of suicidality and self-harm.ObjectiveTo assess the association between use of GLP-1 receptor agonists and the risk of suicide death in routine clinical practice.Design, Setting, and ParticipantsThis active-comparator new-user cohort study used nationwide register data from Sweden and Denmark from 2013 to 2021. Adults 18 to 84 years old who initiated treatment with GLP-1 receptor agonists or the comparator sodium-glucose cotransporter-2 (SGLT2) inhibitors were included. Data were analyzed from March to June 2024.ExposureInitiation of treatment with a GLP-1 receptor agonist or SGLT2 inhibitor.Main Outcomes and MeasuresThe primary outcome was suicide death recorded in the cause of death registers. Secondary outcomes were the composite of suicide death and nonfatal self-harm and the composite of incident depression and anxiety-related disorders. Using propensity score weighting, hazard ratios (HRs) with 95% CIs were calculated separately in the 2 countries and pooled in a meta-analysis.ResultsIn total, 124 517 adults initiated a GLP-1 receptor agonist and 174 036 initiated an SGLT2 inhibitor; among GLP-1 receptor agonist users, the mean (SD) age was 60 (13) years, and 45% were women. During a mean (SD) follow-up of 2.5 (1.7) years, 77 suicide deaths occurred among users of GLP-1 receptor agonists and 71 suicide deaths occurred among users of SGLT2 inhibitors: weighted incidences were 0.23 vs 0.18 events per 1000 person-years (HR, 1.25; 95% CI, 0.83-1.88), with an absolute difference of 0.05 (95% CI, −0.03 to 0.16) events per 1000 person-years. The HR was 0.83 (95% CI, 0.70-0.97) for suicide death and nonfatal self-harm, and the HR was 1.01 (95% CI, 0.97-1.06) for incident depression and anxiety-related disorders.Conclusions and RelevanceThis cohort study, including mostly patients with type 2 diabetes, does not show an association between use of GLP-1 receptor agonists and an increased risk of suicide death, self-harm, or incident depression and anxiety-related disorders. Suicide death among GLP-1 receptor agonist users was rare, and the upper limit of the confidence interval was compatible with an absolute risk increase of no more than 0.16 events per 1000 person-years.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rasmussen2024,

title = {Early uptake of semaglutide for type 2 diabetes in Scandinavia and characteristics of initiators in Denmark: A register‐based drug utilization study},

author = {Lotte Rasmussen and Jacob Harbo Andersen and Øystein Karlstad and Diego Hernan Giunta and Marie Linder and Kari Furu and Anton Pottegård},

doi = {10.1111/dom.15876},

issn = {1463-1326},

year  = {2024},

date = {2024-11-00},

journal = {Diabetes Obesity Metabolism},

volume = {26},

number = {11},

pages = {5479--5482},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bliddal2024,

title = {Comparison of sociodemographic factors, healthcare utilisation by general practitioner visits, somatic hospital admissions, and medication use in Norway, Sweden, and Denmark},

author = {Mette Bliddal and Emma Bjørk and Øystein Karlstad and Jonas W. Wastesson and Rikke Wesselhoeft and Rune Lindahl-Jacobsen and Anton Pottegård and Maarten Jan Wensink and Lotte Rasmussen},

doi = {10.1016/j.annepidem.2024.07.004},

issn = {1047-2797},

year  = {2024},

date = {2024-10-00},

journal = {Annals of Epidemiology},

volume = {98},

pages = {1--7},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Razaz2024,

title = {Risk of Perinatal and Maternal Morbidity and Mortality Among Pregnant Women With Epilepsy},

author = {Neda Razaz and Jannicke Igland and Marte-Helene Bjørk and K. S. Joseph and Julie Werenberg Dreier and Nils Erik Gilhus and Mika Gissler and Maarit K. Leinonen and Helga Zoega and Silje Alvestad and Jakob Christensen and Torbjörn Tomson},

doi = {10.1001/jamaneurol.2024.2375},

issn = {2168-6149},

year  = {2024},

date = {2024-09-01},

journal = {JAMA Neurol},

volume = {81},

number = {9},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceMaternal epilepsy is associated with adverse pregnancy and neonatal outcomes. A better understanding of this condition and the associated risk of mortality and morbidity at the time of delivery could help reduce adverse outcomes.ObjectiveTo determine the risk of severe maternal and perinatal morbidity and mortality among women with epilepsy.Design, Setting, ParticipantsThis prospective population-based register study in Denmark, Finland, Iceland, Norway, and Sweden took place between January 1, 1996, and December 31, 2017. Data analysis was performed from August 2022 to November 2023. Participants included all singleton births at 22 weeks’ gestation or longer. Births with missing or invalid information on birth weight or gestational length were excluded. The study team identified 4 511 267 deliveries, of which 4 475 984 were to women without epilepsy and 35 283 to mothers with epilepsy.ExposureMaternal epilepsy diagnosis recorded before childbirth. Prenatal exposure to antiseizure medication (ASM), defined as any maternal prescription fills from conception to childbirth, was also examined.Main outcomes and measuresComposite severe maternal morbidity and mortality occurring in pregnancy or within 42 days postpartum and composite severe neonatal morbidity (eg, neonatal convulsions) and perinatal mortality (ie, stillbirths and deaths) during the first 28 days of life. Multivariable generalized estimating equations with logit-link were used to obtain adjusted odds ratios (aORs) and 95% CIs.ResultsThe mean (SD) age at delivery for women in the epilepsy cohort was 29.9 (5.3) years. The rate of composite severe maternal morbidity and mortality was also higher in women with epilepsy compared with those without epilepsy (36.9 vs 25.4 per 1000 deliveries). Women with epilepsy also had a significantly higher risk of death (0.23 deaths per 1000 deliveries) compared with women without epilepsy (0.05 deaths per 1000 deliveries) with an aOR of 3.86 (95% CI, 1.48-8.10). In particular, maternal epilepsy was associated with increased odds of severe preeclampsia, embolism, disseminated intravascular coagulation or shock, cerebrovascular events, and severe mental health conditions. Fetuses and infants of women with epilepsy were at elevated odds of mortality (aOR, 1.20; 95% CI, 1.05-1.38) and severe neonatal morbidity (aOR, 1.48; 95% CI, 1.40-1.56). In analyses restricted to women with epilepsy, women exposed to ASM compared with those unexposed had higher odds of severe maternal morbidity (aOR ,1.24; 95% CI, 1.10-1.48) and their neonates had an increased odd of mortality and severe morbidity (aOR, 1.37; 95% CI, 1.23-1.52).Conclusion and relevanceThis multinational study shows that women with epilepsy were at considerably higher risk of severe maternal and perinatal outcomes and increased risk of death during pregnancy and postpartum. Maternal epilepsy and maternal use of ASM were associated with increased maternal morbidity and perinatal mortality and morbidity.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ankarfeldt2024,

title = {Effectiveness of Baricitinib Risk Minimization Activities in Patients With Rheumatoid Arthritis—A Cohort Study in Four Nordic Countries},

author = {Mikkel Z. Ankarfeldt and Aleksander Søltoft‐Jensen and Claudia A. Salinas and Angela Lupattelli and Eero Pukkala and Kristian Bolin and Sarah Smith and Kristin Joy Meyers and Janne Petersen and Espen Jimenez‐Solem},

doi = {10.1002/pds.70010},

issn = {1099-1557},

year  = {2024},

date = {2024-09-00},

journal = {Pharmacoepidemiology and Drug},

volume = {33},

number = {9},

publisher = {Wiley},

abstract = {ABSTRACTIntroductionBaricitinib received European Medicines Agency (EMA) approval for the treatment of moderate‐to‐severe active rheumatoid arthritis (RA) in 2017. Due to risks including serious infections, increased blood lipid parameters, and missing information regarding safety in pregnancy, additional risk minimization measures (aRMM) including healthcare professional educational material and a patient alert card were implemented to inform on the risks and actions to minimize risk such as the need to screen for tuberculosis and active viral hepatitis before starting baricitinib, monitoring of blood lipids and against use during pregnancy. The aim of the study is to report occurrences of infections, lipid level monitoring and pregnancies, in real world data, to gain insights into whether baricitinib is used in accordance with the aRMM.MethodsA descriptive observational cohort study, utilizing routinely collected data from the Swedish, Norwegian, Finnish, and Danish national registries, was carried out. RA patients initiating baricitinib treatment were identified in the periods 2017–19 (Sweden and Finland), 2017–20 (Norway) and 2017–21 (Denmark). Monitored events included pregnancies, cases of tuberculosis, viral hepatitis, and hyperlipidemia, as well as changes in statin prescriptions (including any of initiation, escalation, reduction or change of statin). Hyperlipidemia and statin use served as proxies for lipid level assessment.ResultsAmong 3908 patients initiating baricitinib (3373 person‐years exposure), eight pregnancies (1% of 815 women aged 18–50 years) potentially overlapped with treatment. During baricitinib treatment, there was a small number of prevalent cases of tuberculosis (less than three events), and a low prevalence of hepatitis (0.2%), and hyperlipidemia (0.5%), whereas 9.3% had start of or changes in statin prescription, indicating lipid level monitoring.ConclusionThe study's findings suggest that patients with RA are treated with baricitinib in accordance with the risk minimization recommendations, particularly concerning pregnancy and infection risks. However, the methods used for assessing lipid levels warrant further refinement for more accurate monitoring.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Engström2024,

title = {Comparative cardiovascular and renal effectiveness of empagliflozin and dapagliflozin: Scandinavian cohort study},

author = {Arvid Engström and Jonas Söderling and Anders Hviid and Björn Eliasson and Soffia Gudbjörnsdottir and Viktor Wintzell and Kristian Hveem and Christian Jonasson and Mads Melbye and Björn Pasternak and Peter Ueda},

doi = {10.1093/ehjcvp/pvae045},

issn = {2055-6845},

year  = {2024},

date = {2024-08-14},

volume = {10},

number = {5},

pages = {432--443},

publisher = {Oxford University Press (OUP)},

abstract = {Abstract

               

                  Aims

                  To assess the comparative cardiovascular and renal effectiveness and safety of empagliflozin vs. dapagliflozin among patients with type 2 diabetes in routine clinical practice.

               

               

                  Methods and results

                  Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, from June 2014 to June 2021 included 141 065 new users of empagliflozin and 58 306 new users of dapagliflozin. Coprimary outcomes were major cardiovascular events (myocardial infarction, stroke, and cardiovascular death), heart failure (hospitalization or death because of heart failure) and serious renal events (renal replacement therapy, hospitalization for renal events, and death from renal causes). Secondary outcomes were the individual components of the primary outcomes, any cause death, and diabetic ketoacidosis. Use of empagliflozin vs. dapagliflozin was associated with similar risk of major cardiovascular events [adjusted incidence rate: 15.9 vs. 15.8 events per 1000 person-years; HR 1.02, (95% confidence interval 0.97–1.08)], heart failure [6.5 vs. 6.3 events per 1000 person-years; HR 1.05 (0.97–1.14)] and serious renal events [3.7 vs. 4.1 events per 1000 person-years; HR 0.97 (0.87–1.07)]. In secondary outcome analyses, the HRs for use of empagliflozin vs. dapagliflozin were 1.00 (0.93–1.07) for myocardial infarction, 1.03 (0.95–1.12) for stroke, 1.01 (0.92–1.13) for cardiovascular death, 1.06 (1.00–1.11) for any cause death, 0.77 (0.60–0.99) for renal replacement therapy, 1.20 (0.75–1.93) for renal death, 1.01 (0.90–1.12) for hospitalization for renal events and 1.12 (0.94–1.33) for diabetic ketoacidosis.

               

               

                  Conclusion

                  Use of empagliflozin and dapagliflozin was associated with similar risk of cardiovascular and renal outcomes, mortality, and diabetic ketoacidosis.

               },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Karlsson2024,

title = {Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006–2019},

author = {Pär Karlsson and Karin Gembert and Suzan Esslinger and Anja Geldhof and Mika Gissler and Maarit K. Leinonen and Marijo Otero‐Lobato and Lars Pedersen and Carolyn E. Cesta},

doi = {10.1002/pds.5878},

issn = {1099-1557},

year  = {2024},

date = {2024-08-00},

journal = {Pharmacoepidemiology and Drug},

volume = {33},

number = {8},

publisher = {Wiley},

abstract = {ABSTRACTPurposeTo present the main findings of a post‐authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in a real‐world setting.MethodsThis observational population‐based cohort study included data from pregnancies ending in 2006–2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases or ulcerative colitis diagnoses were identified. Based on prescription fills from 90 days prior to pregnancy until delivery, infants were assigned to one of the four drug‐exposure cohorts: golimumab, other anti‐TNF biologics, other biologics, and nonbiologic systemic therapy, and the general population. Prevalence of adverse pregnancy outcomes, mortality, diagnoses of major congenital anomalies (MCA), and inpatient infections in the infants' first year of life were assessed. Odds ratios and 95% CIs were calculated for MCA and infection.ResultsAmong 134 infants in the golimumab cohort, none were stillborn or died in the first year of life. MCA were diagnosed in 4.5% of the infants in the golimumab cohort, versus 6.8%, 10.9%, 5.5%, and 4.6% in the other anti‐TNF biologics, other biologics, nonbiologic systemic therapy and general population cohorts, respectively. Inpatient infections were diagnosed in 11% of golimumab‐exposed infants, compared with 9%–11% of infants in the other cohorts. Unadjusted and selected adjusted comparisons showed no association between prenatal golimumab exposure and MCA or infection compared with the other exposure cohorts or general population.ConclusionsThe number of infants with prenatal golimumab exposure was low, but results are reassuringly consistent with the evidence available for other anti‐TNF biologics. Continued monitoring is needed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Leinonen2024,

title = {Socioeconomic differences in use of antiseizure medication in pregnancies with maternal epilepsy: A population‐based study from Nordic universal health care systems},

author = {Maarit K. Leinonen and Jannicke Igland and Julie Werenberg Dreier and Silje Alvestad and Jacqueline M. Cohen and Nils Erik Gilhus and Mika Gissler and Yuelian Sun and Torbjörn Tomson and Helga Zoega and Håkon M. Vegrim and Jakob Christensen and Marte‐Helene Bjørk},

doi = {10.1111/epi.18022},

issn = {1528-1167},

year  = {2024},

date = {2024-08-00},

journal = {Epilepsia},

volume = {65},

number = {8},

pages = {2397--2411},

publisher = {Wiley},

abstract = {AbstractObjectiveResearch points to disparities in disease burden and access to medical care in epilepsy. We studied the association between socioeconomic status (SES) and antiseizure medication (ASM) use in pregnancies with maternal epilepsy.MethodsWe conducted a cross‐sectional study consisting of 21 130 pregnancies with maternal epilepsy identified from Nordic registers during 2006–2017. SES indicators included cohabitation status, migrant background, educational attainment, and household income. Main outcomes were the proportion and patterns of ASM use from 90 days before pregnancy to birth. We applied multiple imputation to handle SES variables with 2%–4% missingness. We estimated adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) using modified Poisson regression with the highest SES category as reference.ResultsMothers with the highest education and the highest income quintile used ASMs least frequently (56% and 53%, respectively). We observed increased risks of ASM discontinuation prior to or during the first trimester for low SES. The risk estimates varied depending on the SES indicator from aRR = 1.27 for low income (95% CI: 1.03–1.57) to aRR = 1.66 for low education (95% CI: 1.30–2.13). Migrant background was associated with ASM initiation after the first trimester (aRR 2.17; 95% CI 1.88–2.52). Low education was associated with the use of valproate during pregnancy in monotherapy (aRR 1.70; 95% CI 1.29–2.24) and in polytherapy (aRR 2.65; 95% CI 1.66–4.21). Low education was also associated with a 37% to 39% increased risk of switching from one ASM to another depending on the ASM used. For the other SES indicators, aRRs of switching varied from 1.16 (foreign origin; 95% CI 1.08–1.26) to 1.26 (not married or cohabiting; 95% CI 1.17–1.36).SignificanceLow SES was associated with riskier patterns of ASM use: discontinuation, late initiation, and switching during pregnancy. These findings may reflect unplanned pregnancies, disparities in access to preconception counseling, and suboptimal care.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Pedersen2024,

title = {Drug utilisation in children and adolescents before and after the start of the COVID‐19 pandemic: Interrupted time‐series analyses in three European countries},

author = {Elisabeth Pedersen and Elena Tripodi and Mia Aakjær and Huiqi Li and Anna Cantarutti and Fredrik Nyberg and Morten Andersen and Angela Lupattelli and Hedvig Nordeng},

doi = {10.1111/ppe.13046},

issn = {1365-3016},

year  = {2024},

date = {2024-08-00},

journal = {Paediatric Perinatal Epid},

volume = {38},

number = {6},

pages = {450--460},

publisher = {Wiley},

abstract = {AbstractBackgroundThe COVID‐19 pandemic has affected children and adolescents in several ways, including worsened mental health, improvement of asthma, and increases in diabetes ketoacidosis. Less is known about how medication use in children and adolescents has been affected by the pandemic.ObjectivesTo explore how the COVID‐19 pandemic affected drug utilisation in children and adolescents in Norway, Sweden, and Italy, by child age.MethodsWe conducted a longitudinal drug utilisation study among all children and adolescents (<18 years old) in Norway and Sweden and a nationwide paediatric database covering 3% of the paediatric population in Italy. We conducted an interrupted time‐series analysis from January 2018 to December 2021, with March 2020 as the interruption point. Dispensing or prescription rates of antidepressants, anxiolytics, sleep medications, attention‐deficit/hyperactivity disorder (ADHD) medications, insulin, and asthma medications were examined.ResultsThe study population in January 2018 consisted of 3,455,521 children and adolescents (136,188 from Italy, 1,160,431 from Norway, and 2,158,902 from Sweden). For sleep medications and insulin, there were only minor changes in level or trend in some age groups after March 2020. For asthma medications, the pandemic was associated with an immediate decrease in dispensing in Norway and Sweden (range of change in level: −19.2 to −3.7 dispensings per 1000 person‐months), and an increasing trend in all countries afterward (range of change in trend: 0.3–6.4 dispensings per 1000 person‐months), especially for the youngest age groups. Among adolescents, the pandemic was associated with an increased trend for ADHD medications, antidepressants, and anxiolytics in Norway and Sweden, but not in Italy.ConclusionsThe increasing trend of psychotropic medication dispensing, especially among adolescents after the start of the pandemic, is concerning and should be investigated further. Aside from a temporary effect on asthma medication dispensing, the pandemic did not greatly affect the dispensing of the medications investigated.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Moreno‐Martos2024,

title = {Impact of the early COVID‐19 pandemic on adult mental health‐related dispensed medications, hospitalizations and specialist outpatient visits in Norway and Sweden: Interrupted time series analysis},

author = {David Moreno‐Martos and Jing Zhao and Huiqi Li and Fredrik Nyberg and Ludvig Daae Bjørndal and Mohammadhossein Hajiebrahimi and Björn Wettermark and Mia Aakjær and Morten Andersen and Maurizio Sessa and Angela Lupattelli and Hedvig Nordeng and Daniel R. Morales},

doi = {10.1111/bcp.16044},

issn = {1365-2125},

year  = {2024},

date = {2024-07-00},

journal = {Brit J Clinical Pharma},

volume = {90},

number = {7},

pages = {1627--1636},

publisher = {Wiley},

abstract = {AimsNorway and Sweden had different early pandemic responses that may have impacted mental health management. The aim was to assess the impact of the early COVID‐19 pandemic on mental health‐related care.MethodsWe used national registries in Norway and Sweden (1 January 2018–31 December 2020) to define 2 cohorts: (i) general adult population; and (ii) mental health adult population. Interrupted times series regression analyses evaluated step and slope changes compared to prepandemic levels for monthly rates of medications (antidepressants, antipsychotics, anxiolytics, hypnotics/sedatives, lithium, opioid analgesics, psychostimulants), hospitalizations (for anxiety, bipolar, depressive/mood, eating and schizophrenia/delusional disorders) and specialist outpatient visits.ResultsIn Norway, immediate reductions occurred in the general population for medications (−12% antidepressants to −7% hypnotics/sedatives) except for antipsychotics; and hospitalizations (−33% anxiety disorders to −17% bipolar disorders). Increasing slope change occurred for all medications except psychostimulants (+1.1%/month hypnotics/sedatives to +1.7%/month antidepressants); and hospitalization for anxiety disorders (+5.5%/month), depressive/mood disorders (+1.7%/month) and schizophrenia/delusional disorders (+2%/month). In Sweden, immediate reductions occurred for antidepressants (−7%) and opioids (−10%) and depressive/mood disorder hospitalizations (−11%) only with increasing slope change in psychostimulant prescribing of (0.9%/month). In contrast to Norway, increasing slope changes occurred in specialist outpatient visits for depressive/mood disorders, eating disorders and schizophrenia/delusional disorders (+1.5, +1.9 and +2.3%/month, respectively). Similar changes occurred in the pre‐existing mental health cohorts.ConclusionDifferences in early COVID‐19 policy response may have contributed to differences in adult mental healthcare provision in Norway and Sweden.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Robijn2024,

title = {Smoking Cessation Pharmacotherapy Use in Pregnancy},

author = {Annelies L. Robijn and Duong T. Tran and Jacqueline M. Cohen and Sarah Donald and Carolyn E. Cesta and Kari Furu and Lianne Parkin and Sallie-Anne Pearson and Johan Reutfors and Helga Zoega and Nicholas Zwar and Alys Havard},

doi = {10.1001/jamanetworkopen.2024.19245},

issn = {2574-3805},

year  = {2024},

date = {2024-06-03},

journal = {JAMA Netw Open},

volume = {7},

number = {6},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceSignificant evidence gaps exist regarding the safety of smoking cessation pharmacotherapies during pregnancy, especially for the risk of congenital malformations. Consequently, professional bodies advise against the use of varenicline and bupropion and recommend caution with nicotine replacement therapy (NRT). Contemporary estimates of the use of smoking cessation pharmacotherapies during pregnancy are lacking.ObjectiveTo quantify the proportion of individuals using prescribed smoking cessation pharmacotherapies during pregnancy and during the first trimester specifically, in 4 countries.Design, Setting, and ParticipantsThis retrospective, population-based cohort study used linked birth records, hospital admission records, and dispensing records of prescribed medications from all pregnancies resulting in birth between 2015 and 2020 in New South Wales, Australia; New Zealand; Norway; and Sweden. Data analyses were conducted in October and November 2023.ExposurePrescribed smoking cessation pharmacotherapy use (varenicline, NRT, and bupropion) during pregnancy was defined as days’ supply overlapping the period from date of conception to childbirth.Main Outcomes and MeasuresPrevalence of use among all pregnancies and pregnancies with maternal smoking were calculated. Among women who used a pharmacotherapy, the proportion of women with use during the first trimester of pregnancy was also calculated.ResultsAmong 1 700 638 pregnancies in 4 countries, 138 033 (8.1%) had maternal smoking and 729 498 (42.9%) were younger than 30 years. The prevalences ranged from 0.02% to 0.14% for varenicline, less than 0.01% to 1.86% for prescribed NRT, and less than 0.01% to 0.07% for bupropion. Among pregnant individuals who smoked, use of pharmacotherapies was up to 10 times higher, with maximum prevalences of 1.25% for varenicline in New South Wales, 11.39% for NRT in New Zealand, and 0.39% for bupropion in New Zealand. Use in the first trimester occurred among more than 90% of individuals using varenicline, approximately 60% among those using NRT, and 80% to 90% among those using bupropion.Conclusions and RelevanceIn this cohort study of pregnant individuals in 4 high-income countries, the low prevalence of varenicline and bupropion use during pregnancy and higher prevalence of NRT use aligned with current clinical guidelines. As most use occurred in the first trimester, there is a need for evidence on the risk of congenital malformations for these medications.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ueda2024b,

title = {Use of DPP4 Inhibitors and GLP-1 Receptor Agonists and Risk of Intestinal Obstruction: Scandinavian Cohort Study},

author = {Peter Ueda and Viktor Wintzell and Mads Melbye and Björn Eliasson and Jonas Söderling and Soffia Gudbjörnsdottir and Kristian Hveem and Christian Jonasson and Henrik Svanström and Anders Hviid and Björn Pasternak},

doi = {10.1016/j.cgh.2023.08.034},

issn = {1542-3565},

year  = {2024},

date = {2024-06-00},

journal = {Clinical Gastroenterology and Hepatology},

volume = {22},

number = {6},

pages = {1226--1237.e14},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Chan2024,

title = {Maternal diabetes and risk of attention-deficit/hyperactivity disorder in offspring in a multinational cohort of 3.6 million mother–child pairs},

author = {Adrienne Y. L. Chan and Le Gao and Miyuki Hsing-Chun Hsieh and Lars J. Kjerpeseth and Raquel Avelar and Tobias Banaschewski and Amy Hai Yan Chan and David Coghill and Jacqueline M. Cohen and Mika Gissler and Jeff Harrison and Patrick Ip and Øystein Karlstad and Wallis C. Y. Lau and Maarit K. Leinonen and Wing Cheong Leung and Tzu-Chi Liao and Johan Reutfors and Shih-Chieh Shao and Emily Simonoff and Kathryn Choon Beng Tan and Katja Taxis and Andrew Tomlin and Carolyn E. Cesta and Edward Chia-Cheng Lai and Helga Zoega and Kenneth K. C. Man and Ian C. K. Wong},

doi = {10.1038/s41591-024-02917-8},

issn = {1546-170X},

year  = {2024},

date = {2024-05-00},

journal = {Nat Med},

volume = {30},

number = {5},

pages = {1416--1423},

publisher = {Springer Science and Business Media LLC},

abstract = {AbstractPrevious studies report an association between maternal diabetes mellitus (MDM) and attention-deficit/hyperactivity disorder (ADHD), often overlooking unmeasured confounders such as shared genetics and environmental factors. We therefore conducted a multinational cohort study with linked mother–child pairs data in Hong Kong, New Zealand, Taiwan, Finland, Iceland, Norway and Sweden to evaluate associations between different MDM (any MDM, gestational diabetes mellitus (GDM) and pregestational diabetes mellitus (PGDM)) and ADHD using Cox proportional hazards regression. We included over 3.6 million mother–child pairs between 2001 and 2014 with follow-up until 2020. Children who were born to mothers with any type of diabetes during pregnancy had a higher risk of ADHD than unexposed children (pooled hazard ratio (HR) = 1.16, 95% confidence interval (CI) = 1.08-1.24). Higher risks of ADHD were also observed for both GDM (pooled HR = 1.10, 95% CI = 1.04-1.17) and PGDM (pooled HR = 1.39, 95% CI = 1.25-1.55). However, siblings with discordant exposure to GDM in pregnancy had similar risks of ADHD (pooled HR = 1.05, 95% CI = 0.94-1.17), suggesting potential confounding by unmeasured, shared familial factors. Our findings indicate that there is a small-to-moderate association between MDM and ADHD, whereas the association between GDM and ADHD is unlikely to be causal. This finding contrast with previous studies, which reported substantially higher risk estimates, and underscores the need to reevaluate the precise roles of hyperglycemia and genetic factors in the relationship between MDM and ADHD.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hviid2024,

title = {Booster vaccination with SARS-CoV-2 mRNA vaccines and myocarditis in adolescents and young adults: a Nordic cohort study},

author = {Anders Hviid and Tuomo A Nieminen and Nicklas Pihlström and Nina Gunnes and Jesper Dahl and Øystein Karlstad and Hanne Løvdal Gulseth and Anders Sundström and Anders Husby and Jørgen Vinsløv Hansen and Rickard Ljung and Petteri Hovi},

doi = {10.1093/eurheartj/ehae056},

issn = {1522-9645},

year  = {2024},

date = {2024-04-14},

volume = {45},

number = {15},

pages = {1327--1335},

publisher = {Oxford University Press (OUP)},

abstract = {Abstract

               

                  Background and Aims

                  The SARS-CoV-2 mRNA vaccines are associated with an increased risk of myocarditis. This association appears to be strongest in male adolescents and younger males and after the second dose. The aim was to evaluate the risk of myocarditis following SARS-CoV-2 mRNA booster vaccination in 12-to-39-year-olds.

               

               

                  Methods

                  A multinational cohort study was conducted using nationwide register data in Denmark, Finland, Norway, and Sweden and comprising all 8.9 million individuals residing in each of the four countries. Participants were followed for an inpatient diagnosis of myocarditis. In each of the four countries, Poisson regression was used to estimate adjusted incidence rate ratios (IRRs) of myocarditis comparing vaccination schedules, with associated 95% confidence intervals (CIs). Country-specific results were combined in meta-analyses.

               

               

                  Results

                  A total of 8.9 million residents were followed for 12 271 861 person-years and 1533 cases of myocarditis were identified. In 12-to-39-year-old males, the 28-day acute risk period following the third dose of BNT162b2 or mRNA-1273 was associated with an increased incidence rate of myocarditis compared to the post-acute risk period 28 days or more after the second dose [IRR 2.08 (95% CI 1.31–3.33) and 8.89 (2.26–35.03), respectively]. For females, the corresponding IRR was only estimable for BNT162b2, 3.99 (0.41–38.64). The corresponding absolute risks following the third dose of BNT162b2 and mRNA-1273 in males were 0.86 (95% CI 0.53–1.32) and 1.95 (0.53–4.99) myocarditis events within 28 days per 100 000 individuals vaccinated, respectively. In females, the corresponding absolute risks following the third dose of BNT162b2 were 0.15 (0.04–0.39) events per 100 000 individuals vaccinated. No deaths occurred within 30 days of vaccine-related cases.

               

               

                  Conclusions

                  The results suggest that a booster dose is associated with increased myocarditis risk in adolescents and young adults. However, the absolute risk of myocarditis following booster vaccination is low.

               },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Pasternak2024,

title = {Glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer: Scandinavian cohort study},

author = {Björn Pasternak and Viktor Wintzell and Anders Hviid and Björn Eliasson and Soffia Gudbjörnsdottir and Christian Jonasson and Kristian Hveem and Henrik Svanström and Mads Melbye and Peter Ueda},

doi = {10.1136/bmj-2023-078225},

issn = {1756-1833},

year  = {2024},

date = {2024-04-10},

journal = {BMJ},

publisher = {BMJ},

abstract = {Abstract

          

            Objective

            To investigate whether use of glucagon-like peptide 1 (GLP1) receptor agonists is associated with increased risk of thyroid cancer.

          

          

            Design

            Scandinavian cohort study.

          

          

            Setting

            Denmark, Norway, and Sweden, 2007-21.

          

          

            Participants

            Patients who started GLP1 receptor agonist treatment were compared with patients who started dipeptidyl peptidase 4 (DPP4) inhibitor treatment, and in an additional analysis, patients who started sodium-glucose cotransporter 2 (SGLT2) inhibitor treatment.

          

          

            Main outcome measures

            Thyroid cancer identified from nationwide cancer registers. An active-comparator new user study design was used to minimise risks of confounding and time related biases from using real world studies of drug effects. Cox regression was used to estimate hazard ratios, controlling for potential confounders with propensity score weighting.

          

          

            Results

            The mean follow-up time was 3.9 years (standard deviation 3.5 years) in the GLP1 receptor agonist group and 5.4 years (standard deviation 3.5 years) in the DPP4 inhibitor group. 76 of 145 410 patients (incidence rate 1.33 events per 10 000 person years) treated with GLP1 receptor agonists and 184 of 291 667 patients (incidence rate 1.46 events per 10 000 person years) treated with DPP4 inhibitors developed thyroid cancer. GLP1 receptor agonist use was not associated with increased risk of thyroid cancer (hazard ratio 0.93, 95% confidence interval 0.66 to 1.31; rate difference −0.13, 95% confidence interval −0.61 to 0.36 events per 10 000 person years). The hazard ratio for medullary thyroid cancer was 1.19 (0.37 to 3.86). In the additional analysis comparing the GLP1 receptor agonist group with the SGLT2 inhibitor group, the hazard ratio for thyroid cancer was 1.16 (0.65 to 2.05).

          

          

            Conclusions

            In this large cohort study using nationwide data from three countries, GLP1 receptor agonist use was not associated with a substantially increased risk of thyroid cancer over a mean follow-up of 3.9 years. In the main analysis comparing GLP1 receptor agonists with DPP4 inhibitors, the upper limit of the confidence interval was consistent with no more than a 31% increase in relative risk.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bruno2024,

title = {Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study},

author = {Claudia Bruno and Carolyn E. Cesta and Vidar Hjellvik and Sinna Pilgaard Ulrichsen and Marte-Helene Bjørk and Buket Öztürk Esen and Malcolm B. Gillies and Mika Gissler and Alys Havard and Øystein Karlstad and Maarit K. Leinonen and Mette Nørgaard and Sallie-Anne Pearson and Johan Reutfors and Kari Furu and Jacqueline M. Cohen and Helga Zoega},

doi = {10.1016/j.eclinm.2024.102531},

issn = {2589-5370},

year  = {2024},

date = {2024-04-00},

journal = {eClinicalMedicine},

volume = {70},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Christensen2024,

title = {Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries},

author = {Jakob Christensen and Helga Zoega and Maarit K. Leinonen and Nils Erik Gilhus and Mika Gissler and Jannicke Igland and Yuelian Sun and Torbjörn Tomson and Silje Alvestad and Marte-Helene Bjørk and Julie Werenberg Dreier},

doi = {10.1016/j.lanepe.2024.100849},

issn = {2666-7762},

year  = {2024},

date = {2024-03-00},

journal = {The Lancet Regional Health - Europe},

volume = {38},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Dreier2024,

title = {Prenatal Exposure to Antiseizure Medications and Risk of Epilepsy in Children of Mothers With Epilepsy},

author = {Julie Werenberg Dreier and Jakob Christensen and Jannicke Igland and Mika Gissler and Maarit K. Leinonen and Håkon Magne Vegrim and Yuelian Sun and Torbjörn Tomson and Helga Zoega and Marte-Helene Bjørk and Rebecca L. Bromley},

doi = {10.1001/jamanetworkopen.2023.56425},

issn = {2574-3805},

year  = {2024},

date = {2024-02-05},

journal = {JAMA Netw Open},

volume = {7},

number = {2},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceUse of valproate and certain other antiseizure medications (ASMs) in pregnancy is associated with abnormal fetal brain development with potential long-term implications for the child.ObjectiveTo examine whether use of valproate and other ASMs in pregnancy among mothers with epilepsy is associated with epilepsy risk in their children.Design, Setting, and ParticipantsThis prospective, population-based register cohort study included singletons born to mothers with epilepsy in Denmark, Finland, Iceland, Norway, and Sweden from January 1, 1996, to December 31, 2017. Data analysis was performed from October 2022 to December 2023.ExposureRedeemed prescription for an ASM from 30 days before pregnancy until birth.Main Outcomes and MeasuresThe main outcome was epilepsy in children, assessed usingInternational Statistical Classification of Diseases and Related Health Problems, Tenth Revisiondiagnoses from hospital care. Adjusted hazard ratios (AHRs) and 95% CIs were estimated using Cox proportional hazards regression. Secondary analyses included dose-response analyses, analyses using children of mothers who discontinued ASM prior to pregnancy as the reference, and sibling analyses.ResultsThis cohort study included 38 663 children of mothers with epilepsy (19 854 [51.4%] boys). Children were followed up from birth; the mean length of follow-up was 7.2 years (range 0-22 years). Compared with 22 207 children of mothers not using an ASM in pregnancy, increased risks of epilepsy in children of mothers who used valproate in pregnancy (monotherapy: AHR, 2.18; 95% CI, 1.70-2.79; polytherapy: AHR, 2.10; 95% CI, 1.49-2.96) were observed. However, there was no dose-dependent association, and there was a similar risk of epilepsy in siblings who were exposed and unexposed to valproate (AHR, 0.95; 95% CI, 0.50-1.82). Prenatal exposure to topiramate monotherapy was associated with increased risk of epilepsy (AHR, 2.32; 95% CI, 1.30-4.16), and the risk was greater for higher doses, but the risk attenuated in comparisons with children of mothers who discontinued topiramate before pregnancy (AHR, 1.19; 95% CI, 0.26-5.44). Prenatal exposure to clonazepam monotherapy was also associated with increased epilepsy risk (AHR, 1.90; 95% CI, 1.16-3.12), but limited follow-up and low numbers precluded further analyses. No associations were observed for prenatal exposure to lamotrigine (AHR, 1.18; 95% CI, 0.95-1.47), levetiracetam (AHR, 1.28; 95% CI, 0.77-2.14), carbamazepine (AHR, 1.13; 95% CI, 0.85-1.50), or oxcarbazepine (AHR, 0.68; 95% CI, 0.44-1.05).Conclusions and RelevanceIn this cohort study of children born to mothers with epilepsy, the associations found between prenatal exposure to certain ASMs and the child’s risk of epilepsy did not persist in sensitivity analyses, suggesting that maternal ASM use in pregnancy may not increase epilepsy risk in children beyond that associated with the maternal epilepsy itself. These findings are reassuring for women in need of treatment with ASM in pregnancy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Brikell2024,

title = {ADHD medication discontinuation and persistence across the lifespan: a retrospective observational study using population-based databases},

author = {Isabell Brikell and Honghui Yao and Lin Li and Aske Astrup and Le Gao and Malcolm B Gillies and Tian Xie and Yanli Zhang-James and Søren Dalsgaard and Anders Engeland and Stephen V Faraone and Jan Haavik and Catharina Hartman and Patrick Ip and Unnur Jakobsdóttir Smári and Henrik Larsson and Kenneth KC Man and Juliana de Oliveira Costa and Sallie-Anne Pearson and Nina Pil Hostrup Nielsen and Harold Snieder and Theresa Wimberley and Ian CK Wong and Le Zhang and Helga Zoega and Kari Klungsøyr and Zheng Chang},

doi = {10.1016/s2215-0366(23)00332-2},

issn = {2215-0366},

year  = {2024},

date = {2024-01-00},

journal = {The Lancet Psychiatry},

volume = {11},

number = {1},

pages = {16--26},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Engström2023,

title = {Association of glucagon-like peptide-1 receptor agonists with serious liver events among patients with type 2 diabetes: A Scandinavian cohort study},

author = {Arvid Engström and Viktor Wintzell and Mads Melbye and Henrik Svanström and Björn Eliasson and Soffia Gudbjörnsdottir and Kristian Hveem and Christian Jonasson and Anders Hviid and Peter Ueda and Björn Pasternak},

doi = {10.1097/hep.0000000000000712},

issn = {0270-9139},

year  = {2024},

date = {2024-00-00},

volume = {79},

number = {6},

pages = {1401--1411},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {

            Background and Aims:

            Clinical trials suggest that glucagon-like peptide-1 (GLP-1) receptor agonists may have beneficial effects on NAFLD, but the impact on hard hepatic end points is unknown. We assessed the association between the use of GLP-1 receptor agonists and the risk of serious liver events in routine clinical practice.

          

          

            Approach and Results:

            Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, 2007–2020, including 91,479 initiators of GLP-1 receptor agonists and 244,004 initiators of the active comparator, dipeptidyl peptidase-4 inhibitors, without a history of chronic liver disease other than NAFLD/NASH. The primary outcome was serious liver events: a composite of incident compensated and decompensated cirrhosis and HCC. Secondary outcomes were the individual components of the primary outcome. Cox regression was used to estimate HRs, using propensity score weighting to control for confounding. Users of GLP-1 receptor agonists had 608 serious liver events (adjusted incidence rate: 16.9 events per 10,000 person-years), compared with 1770 events among users of dipeptidyl peptidase-4 inhibitors (19.2 events per 10,000 person-years). The adjusted HR was 0.85 (95% CI: 0.75 to 0.97), and the rate difference was −2.1 (−4.4 to 0.1) events per 10,000 person-years. In secondary outcome analyses, the adjusted HR was 0.85 (0.75 to 0.97) for compensated and decompensated cirrhosis and 1.05 (0.80 to 1.39) for HCC.

          

          

            Conclusions:

            The use of GLP-1 receptor agonists was associated with a significantly reduced risk of serious liver events, driven by a reduction of compensated and decompensated cirrhosis.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35831669,

title = {Trends in use of attention deficit hyperactivity disorder medication among children and adolescents in Scandinavia in 2010-2020},

author = {Anne Mette Skov Sørensen and Rikke Wesselhöeft and Jacob Harbo Andersen and Johan Reutfors and Carolyn E Cesta and Kari Furu and Ingeborg Hartz and Lotte Rasmussen},

doi = {10.1007/s00787-022-02034-2},

issn = {1435-165X},

year  = {2023},

date = {2023-10-01},

journal = {Eur Child Adolesc Psychiatry},

volume = {32},

number = {10},

pages = {2049--2056},

abstract = {The objective of the study was to compare the use of attention deficit hyperactivity disorder (ADHD) medication among children and adolescents in Scandinavia 2010-2020. Using aggregated prescription data for individuals aged 5-19 years, we calculated annual prevalence proportions of ADHD medication (users/1000 inhabitants) for each country, overall and stratified by age and sex. Overall, use of ADHD medication increased during 2010-2020 in all countries. The increase was pronounced in Sweden reaching 35 users/1000 inhabitants in 2020 (119% increase), whereas it reached 22/1000 in Denmark and Norway (equivalent to a 38% and 16% increase, respectively). Methylphenidate was the most frequently used drug and Sweden had the highest use reaching 25/1000 in 2020 compared to 16/1000 and 18/1000 in Denmark and Norway, respectively. Lisdexamfetamine use increased steadily and was also highest in Sweden (13/1000 in 2020). In 2020, atomoxetine use was higher in Sweden (4.6/1000) and Denmark (4.5/1000) compared to Norway (2.2/1000). From 2015, use of guanfacine increased in Sweden reaching 4.4/1000 in 2020 but remained low in Denmark (0.4/1000) and Norway (0.7/1000). Use of dexamphetamine was low (ranging from 0.47 to 0.75/1000 in 2020) in the three countries. ADHD medication use was highest in Sweden across all age groups. In all countries, the prevalence was higher in males compared to females. In conclusion, use of ADHD medication among children and adolescents in Scandinavia is increasing. The prevalence of use is higher in Sweden for all drug groups compared to Norway and Denmark.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36433783,

title = {Comparative Safety of Antiseizure Medication Monotherapy for Major Malformations},

author = {Jacqueline M Cohen and Silje Alvestad and Carolyn E Cesta and Marte-Helene Bjørk and Maarit K Leinonen and Mette Nørgaard and Kristjana Einarsdóttir and Anders Engeland and Mika Gissler and Øystein Karlstad and Kari Klungsøyr and Ingvild Odsbu and Johan Reutfors and Randi M Selmer and Torbjörn Tomson and Sinna Pilgaard Ulrichsen and Helga Zoega and Kari Furu},

doi = {10.1002/ana.26561},

issn = {1531-8249},

year  = {2023},

date = {2023-03-01},

journal = {Ann Neurol},

volume = {93},

number = {3},

pages = {551--562},

abstract = {OBJECTIVE: This study was undertaken to examine the comparative safety of antiseizure medication (ASM) monotherapy in pregnancy with respect to risk of major congenital malformations (MCMs), overall and by MCM subtype.nnMETHODS: We conducted a population-based cohort study using national health register data from Denmark, Finland, Iceland, Norway, and Sweden (1996-2020). We compared pregnancies with first trimester exposure to lamotrigine monotherapy to ASM-unexposed, carbamazepine, valproate, oxcarbazepine, levetiracetam, and topiramate to lamotrigine monotherapy, and stratified monotherapy groups by dose. The outcome was nongenetic MCM and specific subtypes. We estimated adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) with log-binomial regression and propensity score weights.nnRESULTS: There was a higher crude risk of any MCM in pregnancies exposed to lamotrigine monotherapy (n = 8,339) compared to ASM-unexposed pregnancies (n = 4,866,362), but not after confounder adjustment (aRR = 0.97, 95% CI = 0.87-1.08). Compared to lamotrigine, there was an increased risk of malformations associated with valproate (n = 2,031, aRR = 2.05, 95% CI = 1.70-2.46) and topiramate (n = 509, aRR = 1.81, 95% CI = 1.26-2.60), which increased in a dose-dependent manner. We found no differences in malformation risk for carbamazepine (n = 2,674, aRR = 0.91, 95% CI = 0.72-1.15), oxcarbazepine (n = 1,313, aRR = 1.09, 95% CI = 0.83-1.44), or levetiracetam (n = 1,040, aRR = 0.78, 95% CI = 0.53-1.13). Valproate was associated with several malformation subtypes, including nervous system, cardiac, oral clefts, clubfoot, and hypospadias, whereas lamotrigine and carbamazepine were not.nnINTERPRETATION: Topiramate is associated with an increased risk of MCM similar to that associated with valproate, but lower doses may mitigate the risks for both drugs. Conversely, we found no increased risks for lamotrigine, carbamazepine, oxcarbazepine, or levetiracetam, which is reassuring. ANN NEUROL 2023;93:551-562.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36508322,

title = {Sodium-Glucose Cotransporter 2 Inhibitor Treatment and Risk of Atrial Fibrillation: Scandinavian Cohort Study},

author = {Arvid Engström and Viktor Wintzell and Mads Melbye and Anders Hviid and Björn Eliasson and Soffia Gudbjörnsdottir and Kristian Hveem and Christian Jonasson and Henrik Svanström and Björn Pasternak and Peter Ueda},

doi = {10.2337/dc22-0714},

issn = {1935-5548},

year  = {2023},

date = {2023-02-01},

journal = {Diabetes Care},

volume = {46},

number = {2},

pages = {351--360},

abstract = {OBJECTIVE: To assess the association between use of sodium-glucose cotransporter 2 (SGLT2) inhibitors and the risk of new-onset atrial fibrillation (AF) in routine clinical practice.nnRESEARCH DESIGN AND METHODS: We used nationwide registers in Denmark, Norway, and Sweden from 2013 to 2018 in order to include patients without a history of AF who were newly prescribed an SGLT2 inhibitor or an active comparator (glucagon-like peptide 1 [GLP-1] receptor agonist). We performed a cohort study to assess new-onset AF in intention-to-treat analyses using Cox regression, adjusted for baseline covariates with propensity score weighting.nnRESULTS: We identified 79,343 new users of SGLT2 inhibitors (59.2% dapagliflozin, 40.0% empagliflozin, 0.8% canagliflozin, <0.1% ertugliflozin) and 57,613 new users of GLP-1 receptor agonists. Mean age of the study cohort was 61 years and 60% were men. The adjusted incidence rate of new-onset AF was 8.6 per 1,000 person-years for new users of SGLT2 inhibitors compared with 10.0 per 1,000 person-years for new users of GLP-1 receptor agonists. The adjusted hazard ratio (aHR) was 0.89 (95% CI 0.81-0.96), and the rate difference was 1.4 fewer events per 1,000 person-years (95% CI 0.6-2.1). Using an as-treated exposure definition, the aHR for new-onset AF was 0.87 (95% CI 0.76-0.99). No statistically significant heterogeneity of the aHRs was observed between subgroups of patients with and without a history of heart failure or major cardiovascular disease.nnCONCLUSIONS: In this cohort study using nationwide data from three countries, use of SGLT2 inhibitors, compared with GLP-1 receptor agonists, was associated with a modestly reduced risk of new-onset AF.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Huybrechts2023,

title = {Association of In Utero Antipsychotic Medication Exposure With Risk of Congenital Malformations in Nordic Countries and the US},

author = {Krista F. Huybrechts and Loreen Straub and Pär Karlsson and Laura Pazzagli and Kari Furu and Mika Gissler and Sonia Hernandez-Diaz and Mette Nørgaard and Helga Zoega and Brian T. Bateman and Carolyn E. Cesta and Jacqueline M. Cohen and Maarit K. Leinonen and Johan Reutfors and Randi M. Selmer and Elizabeth A. Suarez and Sinna Pilgaard Ulrichsen and Helle Kieler},

doi = {10.1001/jamapsychiatry.2022.4109},

issn = {2168-622X},

year  = {2023},

date = {2023-02-01},

journal = {JAMA Psychiatry},

volume = {80},

number = {2},

publisher = {American Medical Association (AMA)},

abstract = {ImportancePsychiatric disorders are common among female individuals of reproductive age. While antipsychotic medication use is increasing, the safety of such medications in pregnancy is an area with large evidence gaps.ObjectiveTo evaluate the risk of first-trimester antipsychotic exposure with respect to congenital malformations, focusing on individual drugs and specific malformation subtypes.Design, Setting, and ParticipantsThis cohort study used data from nationwide health registers from the 5 Nordic countries and the US and spanned 1996 to 2018. The Nordic cohort included all pregnancies resulting in singleton live-born infants, and the US cohort consisted of publicly insured mothers linked to their live-born infants nested in the nationwide Medicaid Analytic eXtract. Data were analyzed from November 2020 to April 2022.ExposuresOne or more first-trimester dispensing of any atypical, any typical, and individual antipsychotic drugs.Main Outcomes and MeasuresAny major congenital malformation and specific malformation subtypes previously suggested to be associated with antipsychotic exposure in utero: cardiovascular malformations, oral clefts, neural tube defects, hip dysplasia, limb reduction defects, anorectal atresia/stenosis, gastroschisis, hydrocephalus, other specific brain anomalies, and esophageal disorders. Propensity score stratification was used to control for potential confounders. Pooled adjusted estimates were calculated using indirect standardization.ResultsA total of 6 455 324 unexposed mothers (mean maternal age range across countries: 24-31 years), 21 751 mothers exposed to atypical antipsychotic drugs (mean age range, 26-31 years), and 6371 mothers exposed to typical antipsychotic drugs (mean age range, 27-32 years) were included in the study cohort. Prevalence of any major malformation was 2.7% (95% CI, 2.7%-2.8%) in unexposed infants, 4.3% (95% CI, 4.1%-4.6%) in infants with atypical antipsychotic drug exposure, and 3.1% (95% CI, 2.7%-3.5%) in infants with typical antipsychotic drug exposure in utero. Among the most prevalent exposure-outcome combinations, adjusted relative risks (aRR) were generally close to the null. One exception was olanzapine exposure and oral cleft (aRR, 2.1 [95% CI, 1.1-4.3]); however, estimates varied across sensitivity analyses. Among moderately prevalent combinations, increased risks were observed for gastroschisis and other specific brain anomalies after atypical antipsychotic exposure (aRR, 1.5 [95% CI, 0.8-2.6] and 1.9 [95% CI, 1.1-3.0]) and for cardiac malformations after chlorprothixene exposure (aRR, 1.6 [95% CI, 1.0-2.7]). While the association direction was consistent across sensitivity analyses, confidence intervals were wide, prohibiting firm conclusions.Conclusions and RelevanceIn this study, considering the evidence from primary and sensitivity analyses and inevitable statistical noise for very rare exposure-outcome combinations, in utero antipsychotic exposure generally was not meaningfully associated with an increased risk of malformations. The observed increased risks of oral clefts associated with olanzapine, gastroschisis, and other specific brain anomalies with atypical antipsychotics and cardiac malformations with chlorprothixene requires confirmation as evidence continues to accumulate.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36442654,

title = {Utilization of antidepressants, anxiolytics, and hypnotics during the COVID-19 pandemic in Scandinavia},

author = {Mikael Tiger and Rikke Wesselhoeft and Pär Karlsson and Marte Handal and Mette Bliddal and Carolyn E Cesta and Svetlana Skurtveit and Johan Reutfors},

doi = {10.1016/j.jad.2022.11.068},

issn = {1573-2517},

year  = {2023},

date = {2023-02-01},

journal = {J Affect Disord},

volume = {323},

pages = {292--298},

abstract = {OBJECTIVE: To study patterns of antidepressant, anxiolytic, and hypnotic drug utilization in Denmark, Norway, and Sweden during the first year of the COVID-19 pandemic.nnMETHODS: The monthly observed number of prescription fills of antidepressants, benzodiazepines and benzodiazepine-related hypnotics (BZ), and other anxiolytics and hypnotics (OAH) per population in 2020 were compared with predicted numbers based on analysis of covariance of prescription fills during 2015-2019.nnRESULTS: In March 2020, there was an increased number of prescription fills for antidepressants, anxiolytics, and hypnotics in youths and adults aged 20-59 years in Denmark, Norway, and Sweden. Antidepressant prescription fills increased between 13.5 % and 31.3 % at the end of 2020 in all age groups in Denmark and 17.4 % in youths in Norway. BZ drug prescription fills increased by 20.8 % at the end of 2020 in the 20-59 year age group in Denmark and decreased by 16.7 % in youths in Sweden. A general increase of prescription fills of OAH at the end of 2020 was observed in all countries (range 24.0-80.0 % in Denmark, 11.5-30.8 % in Norway, and 9.1-12.1 % in Sweden). Increases of prescription fills of OAH occurred earlier in Denmark.nnLIMITATIONS: Aggregated data with lack of information on indications.nnCONCLUSIONS: Peaks of utilization of antidepressants, anxiolytics, and hypnotics observed in March 2020 may reflect medication stock piling. Increased antidepressant drug utilization in Denmark and in Norwegian youths together with the general increase in OAH utilization in the Scandinavian countries in late 2020 may indicate an increase of symptoms of depression and anxiety, as well as disturbed sleep.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36445458,

title = {Prevalence trends and individual patterns of ADHD medication use in pregnancy in Norway and Sweden, 2010-2019},

author = {Jacqueline M Cohen and Chaitra Srinivas and Kari Furu and Carolyn E Cesta and Johan Reutfors and Øystein Karlstad},

doi = {10.1007/s00228-022-03428-6},

issn = {1432-1041},

year  = {2023},

date = {2023-01-01},

journal = {Eur J Clin Pharmacol},

volume = {79},

number = {1},

pages = {173--180},

abstract = {PURPOSE: This study aimed to describe recent trends in ADHD medication use in pregnancy in Norway and Sweden, including prevalence, individual characteristics, and patterns of use.nnMETHODS: We studied ADHD medication use (amphetamine, dexamphetamine, methylphenidate, atomoxetine, lisdexamfetamine, guanfacine) by year and age in pregnancies from 2010 to 2019 identified from the medical birth registers (gestational age ≥ 22 weeks) linked to prescribed drug registers (Norway, N = 577,116; Sweden, N = 1,118,988). We compared characteristics of those who used any ADHD medication in pregnancy to no use in pregnancy. Discontinuation was defined as no use after first trimester.nnRESULTS: ADHD medication use increased from 2010 to 2019 by 3.0 users per 1000 pregnancies in Norway (from 2.5 to 5.5/1000) and by 6.3 per 1000 in Sweden (from 1.6 to 7.9/1000), mainly driven by methylphenidate and since 2015 by lisdexamfetamine. Medication use has increased among pregnant individuals of all age groups, with higher use among the youngest. Pregnant individuals who used ADHD medication were less likely to be married/cohabiting, more likely be nulliparous and to smoke. They had particularly high use of co-medication with antidepressants, anxiolytics/hypnotics, and opioids: 42% in Norway and 65% in Sweden used at least one additional class of psychotropic medication. Most individuals discontinued ADHD medication in pregnancy (85% Norway, 78% Sweden).nnCONCLUSION: ADHD medication use during pregnancy increased in Norway and Sweden in the last decade. However, discontinuation rates during pregnancy were high. Those who used ADHD medication had more risk factors for pregnancy complications including low parity, smoking, and other psychotropic drug use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36314353,

title = {Use of benzodiazepines and benzodiazepine-related drugs in the Nordic countries between 2000 and 2020},

author = {Mikkel Højlund and Larus S Gudmundsson and Jacob H Andersen and Leena K Saastamoinen and Helga Zoega and Svetlana O Skurtveit and Jonas W Wastesson and Jesper Hallas and Anton Pottegård},

doi = {10.1111/bcpt.13811},

issn = {1742-7843},

year  = {2023},

date = {2023-01-01},

journal = {Basic Clin Pharmacol Toxicol},

volume = {132},

number = {1},

pages = {60--70},

abstract = {Use of benzodiazepines (BZ) and related drugs is subject to considerable debate due to problems with dependency and adverse events. We aimed to describe and compare their use across the Nordic countries. Data on the use of clonazepam, BZ-sedatives, BZ-hypnotics, and benzodiazepine-related drugs (BZRD) in adults (≥20 years) were obtained from nationwide registers in Denmark, Finland, Iceland, Norway, and Sweden, 2000-2020. Main measures were therapeutic intensity (TI:DDD/1000 inhabitants [inhab.]/day) and annual prevalence (users/1000 inhab./year). Overall, TI of BZ and related drugs decreased in all Nordic countries from 2004 to 2020. However, there were considerable differences between countries in TI. In 2020, the TI of BZ and related drugs ranged from 17 DDD/1000 inhab./day in Denmark to 93 DDD/1000 inhab./day in Iceland. BZRD accounted for 55-78% of BZ use in 2020, followed by BZ sedatives at 20-44%, BZ-hypnotics at <1-5%, and clonazepam at <1-2%. Annual prevalence of BZ use increased with age in all countries, and the highest annual prevalence was observed among people ≥80 years. Overall, the use of BZ and related drugs has decreased in all Nordic countries from 2004 to 2020, however, with considerable differences in their use between countries. The highest prevalence was observed among the oldest age groups-despite warnings against their use in this population.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36028603,

title = {Risk of Major Cardiovascular and Cerebrovascular Events in Users of Lisdexamfetamine and Other Medications for Attention-Deficit/Hyperactivity Disorder in Denmark and Sweden: A Population-Based Cohort Study},

author = {Joan Forns and Elena Dudukina and David Hägg and Péter Szentkúti and Karin Gembert and Estel Plana and Alicia Gilsenan and Erzsébet Horváth-Puhó and Vera Ehrenstein and Johan Reutfors and Cristina Rebordosa},

doi = {10.1007/s40120-022-00396-y},

issn = {2193-8253},

year  = {2022},

date = {2022-12-01},

journal = {Neurol Ther},

volume = {11},

number = {4},

pages = {1659--1676},

abstract = {INTRODUCTION: This study aimed to estimate risks of cardiovascular and cerebrovascular events in patients treated with lisdexamfetamine dimesylate (LDX) compared with patients previously treated with other attention-deficit/hyperactivity disorder (ADHD) medications (amphetamine, dexamphetamine, methylphenidate or atomoxetine).nnMETHODS: This population-based cohort study used data from Danish and Swedish medical and administrative national registers. The LDX cohort included adult patients initiating LDX with at least 12 months' data preceding first LDX dispensing (index date). A random sample of patients treated with at least one non-LDX ADHD medication in the 6-24 months (but not less than 6 months) before index date (previous-users cohort) were matched to LDX users on age, sex, region and calendar year. The primary outcome, a composite of major adverse cardiovascular and cerebrovascular events (MACE), included first hospitalisation for acute myocardial infarction or stroke and out-of-hospital coronary heart disease or cerebrovascular disease death. Incidence rates (IRs) and IR ratios (IRRs) with 95% confidence intervals (CIs) of MACE were estimated using Poisson regression.nnRESULTS: From Denmark/Sweden, 5516/40,163 LDX users and 27,494/200,389 previous users were included. In Denmark, IRs of MACE/1000 person-years (95% CI) were similar for LDX (1.63 [0.85-3.14]) and previous users (1.61 [1.28-2.01]). In Sweden, IRs (95% CI) were 1.40 (1.09-1.79) in LDX users and 1.17 (1.00-1.38) in previous users. Adjusted MACE IRRs (95% CI) for LDX versus previous use were 1.01 (0.48-2.13) in Denmark, 1.13 (0.75-1.71) in Sweden, and 1.10 (0.77-1.58) in the pooled analysis.nnCONCLUSION: Our findings suggest little to no increased risk of cardiovascular and cerebrovascular events in patients treated with LDX compared with patients previously treated with other ADHD medications.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36156660,

title = {Cancer Risk in Children of Mothers With Epilepsy and High-Dose Folic Acid Use During Pregnancy},

author = {Håkon Magne Vegrim and Julie Werenberg Dreier and Silje Alvestad and Nils Erik Gilhus and Mika Gissler and Jannicke Igland and Maarit K Leinonen and Torbjörn Tomson and Yuelian Sun and Helga Zoega and Jakob Christensen and Marte-Helene Bjørk},

doi = {10.1001/jamaneurol.2022.2977},

issn = {2168-6157},

year  = {2022},

date = {2022-11-01},

journal = {JAMA Neurol},

volume = {79},

number = {11},

pages = {1130--1138},

abstract = {IMPORTANCE: Women with epilepsy are recommended high doses of folic acid before and during pregnancy owing to risk of congenital anomalies associated with antiseizure medications. Whether prenatal exposure to high-dose folic acid is associated with increases in the risk of childhood cancer is unknown.nnOBJECTIVE: To assess whether high-dose folic acid supplementation in mothers with epilepsy is associated with childhood cancer.nnDESIGN, SETTING, AND PARTICIPANTS: Observational cohort study conducted with nationwide registers in Denmark, Norway, and Sweden from 1997 to 2017. Analyses were performed during January 10, 2022, to January 31, 2022. Mother-child pairs were identified in medical birth registers and linked with information from patient, prescription, and cancer registers, as well as with sociodemographic information from statistical agencies, and were categorized by maternal diagnosis of epilepsy. The study population consisted of 3 379 171 children after exclusion of 126 711 children because of stillbirth or missing or erroneous values on important covariates.nnEXPOSURES: Maternal prescription fills for high-dose folic acid tablets (≥1 mg daily) between 90 days before pregnancy start and birth.nnMAIN OUTCOMES AND MEASURES: First onset of childhood cancer at younger than 20 years. Cox proportional hazards models were used to calculate adjusted hazard ratios with corresponding 95% CIs, adjusted for potential confounders. Cumulative incidence at aged 20 years was used as a measure of absolute risk.nnRESULTS: The median age at the end of follow-up in the study population of 3 379 171 children was 7.3 years (IQR, 3.5-10.9 years). Among the 27 784 children (51.4% male) born to mothers with epilepsy, 5934 (21.4%) were exposed to high-dose folic acid (mean dose, 4.3 mg), with 18 exposed cancer cases compared with 29 unexposed, producing an adjusted hazard ratio of 2.7 (95% CI, 1.2-6.3), absolute risk if exposed of 1.4% (95% CI, 0.5%-3.6%), and absolute risk if unexposed of 0.6% (95% CI, 0.3%-1.1%). In children of mothers without epilepsy, 46 646 (1.4%) were exposed to high-dose folic acid (mean dose, 2.9 mg), with 69 exposed and 4927 unexposed cancer cases and an adjusted hazard ratio of 1.1 (95% CI, 0.9-1.4; absolute risk, 0.4% [95% CI, 0.3%-0.5%]). There was no association between children born to mothers with epilepsy who were prenatally exposed to antiseizure medications, but not high-dose folic acid, and an increased risk of cancer (absolute risk, 0.6%; 95% CI, 0.2%-1.3%).nnCONCLUSIONS AND RELEVANCE: Prenatal exposure to high-dose folic acid was associated with increased risk of cancer in children of mothers with epilepsy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35265981,

title = {Oral anticoagulants in patients with atrial fibrillation at low stroke risk: a multicentre observational study},

author = {Joris J Komen and Anton Pottegård and Aukje K Mantel-Teeuwisse and Tomas Forslund and Paul Hjemdahl and Björn Wettermark and Jesper Hallas and Morten Olesen and Marion Bennie and Tanja Mueller and Raymond Carragher and Øystein Karlstad and Lars J Kjerpeseth and Olaf H Klungel},

doi = {10.1093/eurheartj/ehac111},

issn = {1522-9645},

year  = {2022},

date = {2022-10-01},

journal = {Eur Heart J},

volume = {43},

number = {37},

pages = {3528--3538},

abstract = {AIMS: There is currently no consensus on whether atrial fibrillation (AF) patients at low risk for stroke (one non-sex-related CHA2DS2-VASc point) should be treated with an oral anticoagulant.nnMETHODS AND RESULTS: We conducted a multi-country cohort study in Sweden, Denmark, Norway, and Scotland. In total, 59 076 patients diagnosed with AF at low stroke risk were included. We assessed the rates of stroke or major bleeding during treatment with a non-vitamin K antagonist oral anticoagulant (NOAC), a vitamin K antagonist (VKA), or no treatment, using inverse probability of treatment weighted (IPTW) Cox regression. In untreated patients, the rate for ischaemic stroke was 0.70 per 100 person-years and the rate for a bleed was also 0.70 per 100 person-years. Comparing NOAC with no treatment, the stroke rate was lower [hazard ratio (HR) 0.72; 95% confidence interval (CI) 0.56-0.94], and the rate for intracranial haemorrhage (ICH) was not increased (HR 0.84; 95% CI 0.54-1.30). Comparing VKA with no treatment, the rate for stroke tended to be lower (HR 0.81; 95% CI 0.59-1.09), and the rate for ICH tended to be higher during VKA treatment (HR 1.37; 95% CI 0.88-2.14). Comparing NOAC with VKA treatment, the rate for stroke was similar (HR 0.92; 95% CI 0.70-1.22), but the rate for ICH was lower during NOAC treatment (HR 0.63; 95% CI 0.42-0.94).nnCONCLUSION: These observational data suggest that NOAC treatment may be associated with a positive net clinical benefit compared with no treatment or VKA treatment in patients at low stroke risk, a question that can be tested through a randomized controlled trial.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35842337,

title = {COVID-19 vaccination in pregnant women in Sweden and Norway},

author = {Anne K Örtqvist and Elisabeth Dahlqwist and Maria C Magnus and Rickard Ljung and Jerker Jonsson and Bernice Aronsson and Björn Pasternak and Siri E Håberg and Olof Stephansson},

doi = {10.1016/j.vaccine.2022.06.083},

issn = {1873-2518},

year  = {2022},

date = {2022-08-01},

journal = {Vaccine},

volume = {40},

number = {33},

pages = {4686--4692},

abstract = {Vaccines against SARS-CoV-2 are highly effective in preventing severe disease and mortality. Although pregnant women are at increased risk of severe COVID-19, vaccination uptake among pregnant women varies. We used the Swedish and Norwegian population-based health registries to identify pregnant women and to investigate background characteristics associated with not being vaccinated. In this study of 164 560 women giving birth between May 2021 and May 2022, 78% in Sweden and 87% in Norway have been vaccinated with at least one dose at delivery. Not being vaccinated while being pregnant was associated with age below 30 years, low education and income level, birth region other than Scandinavia, smoking during pregnancy, not living with a partner, and gestational diabetes. These results can assist health authorities develop targeted vaccination information to diminish vaccination inequality and prevent severe disease in vulnerable groups.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34244745,

title = {Effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in atrial fibrillation: a Scandinavian population-based cohort study},

author = {Sigrun Halvorsen and Søren P Johnsen and Morten Madsen and Marie Linder and Gerhard Sulo and Waleed Ghanima and Gunnar Gislason and Stefan H Hohnloser and Aaron Jenkins and Faris Al-Khalili and Grethe S Tell and Vera Ehrenstein},

doi = {10.1093/ehjqcco/qcab048},

issn = {2058-1742},

year  = {2022},

date = {2022-08-01},

journal = {Eur Heart J Qual Care Clin Outcomes},

volume = {8},

number = {5},

pages = {577--587},

abstract = {AIMS: Using Scandinavian population-based registries, we assessed risk of stroke/systemic embolism (SE) and bleeding with non-vitamin K antagonist oral anticoagulants compared with warfarin in anticoagulation-naïve patients with atrial fibrillation (AF).nnMETHODS AND RESULTS: This historical cohort study included 219 545 AF patients [median age 74 years; 43% women; mean CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischaemic attack, vascular disease, age 65-74 years, sex category) score 3.3] initiating apixaban, dabigatran, rivaroxaban, or warfarin in Denmark, Norway, and Sweden (1 January 2013 to 31 December 2016). The primary endpoints were stroke/SE and major bleeding. The median follow-up times were 9.7 (3.9-21.5) months for stroke/SE and 9.6 (3.8-21.3) months for bleeding. Apixaban and warfarin initiators were older and had higher CHA2DS2-VASc scores compared with dabigatran and rivaroxaban initiators. After 1:1 propensity score matching, three cohorts were created: apixaban-warfarin (n = 111 162), dabigatran-warfarin (n = 56 856), and rivaroxaban-warfarin (n = 61 198). Adjusted hazard ratios (HRs) were estimated using a Cox regression. For stroke/SE, adjusted HRs against warfarin were 0.96 [95% confidence interval (CI): 0.87-1.06] for apixaban, 0.89 (95% CI: 0.80-1.00) for dabigatran, and 1.03 (95% CI: 0.92-1.14) for rivaroxaban. For major bleeding, the HRs against warfarin were 0.73 (95% CI: 0.67-0.78) for apixaban, 0.89 (95% CI: 0.82-0.97) for dabigatran, and 1.15 (95% CI: 1.07-1.25) for rivaroxaban. The results in the dabigatran cohort did not hold in all dose-defined subgroups.nnCONCLUSION: In this large Scandinavian study among AF patients initiating oral anticoagulation, those initiating dabigatran, apixaban, and rivaroxaban had similar rates of stroke/SE to patients initiating warfarin. Rates of major bleeding were lower with apixaban and dabigatran and higher with rivaroxaban, each compared with warfarin.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35639399,

title = {Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability},

author = {Marte-Helene Bjørk and Helga Zoega and Maarit K Leinonen and Jacqueline M Cohen and Julie Werenberg Dreier and Kari Furu and Nils Erik Gilhus and Mika Gissler and Óskar Hálfdánarson and Jannicke Igland and Yuelian Sun and Torbjörn Tomson and Silje Alvestad and Jakob Christensen},

doi = {10.1001/jamaneurol.2022.1269},

issn = {2168-6157},

year  = {2022},

date = {2022-07-01},

journal = {JAMA Neurol},

volume = {79},

number = {7},

pages = {672--681},

abstract = {IMPORTANCE: Women with epilepsy frequently need antiseizure medication (ASM) to prevent seizures in pregnancy. Risk of neurodevelopmental disorders after prenatal exposure to AMSs is uncertain.nnOBJECTIVE: To determine whether children exposed prenatally to ASMs in monotherapy and duotherapy have increased risk of neurodevelopmental disorders.nnDESIGN, SETTING, AND PARTICIPANTS: The Nordic register-based study of antiepileptic drugs in pregnancy (SCAN-AED) is a population-based cohort study using health register and social register data from Denmark, Finland, Iceland, Norway, and Sweden (1996-2017; analysis performed February 2022). From 4 702 774 alive-born children with available mother-child identities and maternal prescription data, this study included 4 494 926 participants. Children from a multiple pregnancy or with chromosomal disorders or uncertain pregnancy length were excluded (n = 207 848).nnEXPOSURES: Prenatal exposure to ASM determined from maternal prescription fills between last menstrual period and birth.nnMAIN OUTCOMES AND MEASURES: We estimated cumulative incidence at age 8 years in exposed and unexposed children. Cox regression adjusted for potential confounders yielded adjusted hazard ratios (aHRs) with 95% CIs for autism spectrum disorder (ASD), intellectual disability (ID), or any neurodevelopmental disorder (ASD and/or ID).nnRESULTS: A total of 4 494 926 children were included; 2 306 993 (51.3%) were male, and the median (IQR) age at end of follow-up was 8 (4.0-12.1) years. Among 21 634 unexposed children of mothers with epilepsy, 1.5% had a diagnosis of ASD and 0.8% (numerators were not available because of personal data regulations in Denmark) of ID by age 8 years. In same-aged children of mothers with epilepsy exposed to topiramate and valproate monotherapy, 4.3% and 2.7%, respectively, had ASD, and 3.1% and 2.4% had ID. The aHRs for ASD and ID after topiramate exposure were 2.8 (95% CI, 1.4-5.7) and 3.5 (95% CI, 1.4-8.6), respectively, and after valproate exposure were 2.4 (95% CI, 1.7-3.3) and 2.5 (95% CI, 1.7-3.7). The aHRs were elevated with higher ASM doses compared with children from the general population. The duotherapies levetiracetam with carbamazepine and lamotrigine with topiramate were associated with increased risks of neurodevelopmental disorders in children of women with epilepsy: levetiracetam with carbamazepine: 8-year cumulative incidence, 5.7%; aHR, 3.5; 95% CI, 1.5-8.2; lamotrigine with topiramate: 8-year cumulative incidence, 7.5%; aHR, 2.4; 95% CI, 1.1-4.9. No increased risk was associated with levetiracetam with lamotrigine (8-year cumulative incidence, 1.6%; aHR, 0.9; 95% CI, 0.3-2.5). No consistently increased risks were observed for neurodevelopmental disorders after prenatal exposure to monotherapy with lamotrigine, levetiracetam, carbamazepin, oxcarbazepine, gapapentin, pregabalin, clonazepam, or phenobarbital.nnCONCLUSIONS AND RELEVANCE: In this cohort study, prenatal exposure to topiramate, valproate, and several duotherapies were associated with increased risks of neurodevelopmental disorders.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35442390,

title = {SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents},

author = {Øystein Karlstad and Petteri Hovi and Anders Husby and Tommi Härkänen and Randi Marie Selmer and Nicklas Pihlström and Jørgen Vinsløv Hansen and Hanna Nohynek and Nina Gunnes and Anders Sundström and Jan Wohlfahrt and Tuomo A Nieminen and Maria Grünewald and Hanne Løvdal Gulseth and Anders Hviid and Rickard Ljung},

doi = {10.1001/jamacardio.2022.0583},

issn = {2380-6591},

year  = {2022},

date = {2022-06-01},

journal = {JAMA Cardiol},

volume = {7},

number = {6},

pages = {600--612},

abstract = {IMPORTANCE: Reports of myocarditis after SARS-CoV-2 messenger RNA (mRNA) vaccination have emerged.nnOBJECTIVE: To evaluate the risks of myocarditis and pericarditis following SARS-CoV-2 vaccination by vaccine product, vaccination dose number, sex, and age.nnDESIGN, SETTING, AND PARTICIPANTS: Four cohort studies were conducted according to a common protocol, and the results were combined using meta-analysis. Participants were 23 122 522 residents aged 12 years or older. They were followed up from December 27, 2020, until incident myocarditis or pericarditis, censoring, or study end (October 5, 2021). Data on SARS-CoV-2 vaccinations, hospital diagnoses of myocarditis or pericarditis, and covariates for the participants were obtained from linked nationwide health registers in Denmark, Finland, Norway, and Sweden.nnEXPOSURES: The 28-day risk periods after administration date of the first and second doses of a SARS-CoV-2 vaccine, including BNT162b2, mRNA-1273, and AZD1222 or combinations thereof. A homologous schedule was defined as receiving the same vaccine type for doses 1 and 2.nnMAIN OUTCOMES AND MEASURES: Incident outcome events were defined as the date of first inpatient hospital admission based on primary or secondary discharge diagnosis for myocarditis or pericarditis from December 27, 2020, onward. Secondary outcome was myocarditis or pericarditis combined from either inpatient or outpatient hospital care. Poisson regression yielded adjusted incidence rate ratios (IRRs) and excess rates with 95% CIs, comparing rates of myocarditis or pericarditis in the 28-day period following vaccination with rates among unvaccinated individuals.nnRESULTS: Among 23 122 522 Nordic residents (81% vaccinated by study end; 50.2% female), 1077 incident myocarditis events and 1149 incident pericarditis events were identified. Within the 28-day period, for males and females 12 years or older combined who received a homologous schedule, the second dose was associated with higher risk of myocarditis, with adjusted IRRs of 1.75 (95% CI, 1.43-2.14) for BNT162b2 and 6.57 (95% CI, 4.64-9.28) for mRNA-1273. Among males 16 to 24 years of age, adjusted IRRs were 5.31 (95% CI, 3.68-7.68) for a second dose of BNT162b2 and 13.83 (95% CI, 8.08-23.68) for a second dose of mRNA-1273, and numbers of excess events were 5.55 (95% CI, 3.70-7.39) events per 100 000 vaccinees after the second dose of BNT162b2 and 18.39 (9.05-27.72) events per 100 000 vaccinees after the second dose of mRNA-1273. Estimates for pericarditis were similar.nnCONCLUSIONS AND RELEVANCE: Results of this large cohort study indicated that both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis. For individuals receiving 2 doses of the same vaccine, risk of myocarditis was highest among young males (aged 16-24 years) after the second dose. These findings are compatible with between 4 and 7 excess events in 28 days per 100 000 vaccinees after BNT162b2, and between 9 and 28 excess events per 100 000 vaccinees after mRNA-1273. This risk should be balanced against the benefits of protecting against severe COVID-19 disease.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34810174,

title = {Antipsychotic use in pregnancy and risk of attention/deficit-hyperactivity disorder and autism spectrum disorder: a Nordic cohort study},

author = {Óskar Hálfdánarson and Jacqueline M Cohen and Øystein Karlstad and Carolyn E Cesta and Marte-Helene Bjørk and Siri Eldevik Håberg and Kristjana Einarsdóttir and Kari Furu and Mika Gissler and Vidar Hjellvik and Helle Kieler and Maarit K Leinonen and Mette Nørgaard and Buket Öztürk Essen and Sinna Pilgaard Ulrichsen and Johan Reutfors and Helga Zoega},

doi = {10.1136/ebmental-2021-300311},

issn = {1468-960X},

year  = {2022},

date = {2022-05-01},

journal = {Evid Based Ment Health},

volume = {25},

number = {2},

pages = {54--62},

abstract = {BACKGROUND: Antipsychotics are increasingly used among women of childbearing age and during pregnancy.nnOBJECTIVE: To determine whether children exposed to antipsychotics  are at increased risk of attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD), accounting for maternal diagnoses of bipolar, psychotic and other psychiatric disorders.  Population-based cohort study, including a sibling analysis.  Nationwide data on all pregnant women and their live-born singletons in Denmark (1997-2017), Finland (1996-2016), Iceland (2004-2017), Norway (2004-2017), and Sweden (2006-2016).  4 324 086 children were eligible for inclusion to the study cohort.  Antipsychotic exposure , assessed by pregnancy trimester, type of antipsychotic, and varying patterns of use.  Non-mutually exclusive diagnoses of ADHD and ASD. We used Cox proportional hazard models to calculate hazard ratios (HRs) controlling for maternal psychiatric disorders and other potential confounding factors.nnFINDINGS: Among 4 324 086 singleton births, 15 466 (0.4%) were exposed to antipsychotics . During a median follow-up of 10 years, we identified 72 257 children with ADHD and 38 674 children with ASD. Unadjusted HRs were raised for both outcomes but shifted substantially towards the null after adjustment; 1.10 (95%CI 1.00 to 1.27) for ADHD and 1.12 (0.97 to 1.29) for ASD. Adjusted HRs remained consistent by trimester of exposure and type of antipsychotic. Comparing  exposure with pre-pregnancy use yielded HRs of 0.74 (0.62 to 0.87) for ADHD and 0.88 (0.70 to 1.10) for ASD. Sibling analyses yielded HRs of 1.14 (0.79 to 1.64) for ADHD and 1.34 (0.75 to 2.39) for ASD.nnDISCUSSION: Our findings suggest little or no increased risk of child ADHD or ASD after  exposure to antipsychotics.nnCLINICAL IMPLICATIONS: Results regarding child neurodevelopment are reassuring for women who need antipsychotics during pregnancy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35578167,

title = {Prescription opioids among older adults: ten years of data across five countries},

author = {A Hamina and A E Muller and T Clausen and S Skurtveit and M Hesse and C Tjagvad and B Thylstrup and I Odsbu and H Zoega and H L Jónsdóttir and H Taipale},

doi = {10.1186/s12877-022-03125-0},

issn = {1471-2318},

year  = {2022},

date = {2022-05-01},

journal = {BMC Geriatr},

volume = {22},

number = {1},

pages = {429},

abstract = {BACKGROUND: Opioid use has increased globally in the recent decade. Although pain remains a significant problem among older adults, susceptibility to opioid-related harms highlights the importance of careful opioid therapy monitoring on individual and societal levels. We aimed to describe the trends of prescription opioid utilisation among residents aged ≥65 in all Nordic countries during 2009-2018.nnMETHODS: We conducted cross-sectional measurements of opioid utilisation in 2009-2018 from nationwide registers of dispensed drugs in Denmark, Finland, Iceland, Norway, and Sweden. The measures included annual opioid prevalence, defined daily doses (DDDs) per 1000 inhabitants per day (DIDs), and morphine milligram equivalents (MMEs) per user per day.nnRESULTS: From 2009 to 2018, an average of 808,584 of adults aged ≥65 used opioids yearly in all five countries; an average annual prevalence of 17.0%. During this time period, the prevalence decreased in Denmark, Norway, and Sweden due to declining codeine and/or tramadol use. Iceland had the highest opioid prevalence in 2009 (30.2%), increasing to 31.7% in 2018. In the same period, DIDs decreased in all five countries, and ranged from 28.3 in Finland to 58.5 in Denmark in 2009, and from 23.0 in Finland to 54.6 in Iceland in 2018. MMEs/user/day ranged from 4.4 in Iceland to 19.6 in Denmark in 2009, and from 4.6 in Iceland to 18.8 in Denmark in 2018. In Finland, Norway, and Sweden, MMEs/user/day increased from 2009 to 2018, mainly due to increasing oxycodone utilisation.nnCONCLUSIONS: The stable or decreasing opioid utilisation prevalence among a majority of older adults across the Nordic countries coincides with an increase in treatment intensity in 2009-2018. We found large cross-national differences despite similarities across the countries' cultures and healthcare systems. For the aged population, national efforts should be placed on improving pain management and monitoring future trends of especially oxycodone utilisation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34810174b,

title = {Antipsychotic use in pregnancy and risk of attention/deficit-hyperactivity disorder and autism spectrum disorder: a Nordic cohort study},

author = {Óskar Hálfdánarson and Jacqueline M Cohen and Øystein Karlstad and Carolyn E Cesta and Marte-Helene Bjørk and Siri Eldevik Håberg and Kristjana Einarsdóttir and Kari Furu and Mika Gissler and Vidar Hjellvik and Helle Kieler and Maarit K Leinonen and Mette Nørgaard and Buket Öztürk Essen and Sinna Pilgaard Ulrichsen and Johan Reutfors and Helga Zoega},

doi = {10.1136/ebmental-2021-300311},

issn = {1468-960X},

year  = {2022},

date = {2022-05-01},

journal = {Evid Based Ment Health},

volume = {25},

number = {2},

pages = {54--62},

abstract = {BACKGROUND: Antipsychotics are increasingly used among women of childbearing age and during pregnancy.nnOBJECTIVE: To determine whether children exposed to antipsychotics  are at increased risk of attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD), accounting for maternal diagnoses of bipolar, psychotic and other psychiatric disorders.  Population-based cohort study, including a sibling analysis.  Nationwide data on all pregnant women and their live-born singletons in Denmark (1997-2017), Finland (1996-2016), Iceland (2004-2017), Norway (2004-2017), and Sweden (2006-2016).  4 324 086 children were eligible for inclusion to the study cohort.  Antipsychotic exposure , assessed by pregnancy trimester, type of antipsychotic, and varying patterns of use.  Non-mutually exclusive diagnoses of ADHD and ASD. We used Cox proportional hazard models to calculate hazard ratios (HRs) controlling for maternal psychiatric disorders and other potential confounding factors.nnFINDINGS: Among 4 324 086 singleton births, 15 466 (0.4%) were exposed to antipsychotics . During a median follow-up of 10 years, we identified 72 257 children with ADHD and 38 674 children with ASD. Unadjusted HRs were raised for both outcomes but shifted substantially towards the null after adjustment; 1.10 (95%CI 1.00 to 1.27) for ADHD and 1.12 (0.97 to 1.29) for ASD. Adjusted HRs remained consistent by trimester of exposure and type of antipsychotic. Comparing  exposure with pre-pregnancy use yielded HRs of 0.74 (0.62 to 0.87) for ADHD and 0.88 (0.70 to 1.10) for ASD. Sibling analyses yielded HRs of 1.14 (0.79 to 1.64) for ADHD and 1.34 (0.75 to 2.39) for ASD.nnDISCUSSION: Our findings suggest little or no increased risk of child ADHD or ASD after  exposure to antipsychotics.nnCLINICAL IMPLICATIONS: Results regarding child neurodevelopment are reassuring for women who need antipsychotics during pregnancy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35323851,

title = {Association of SARS-CoV-2 Vaccination During Pregnancy With Pregnancy Outcomes},

author = {Maria C Magnus and Anne K Örtqvist and Elisabeth Dahlqwist and Rickard Ljung and Fredrik Skår and Laura Oakley and Ferenc Macsali and Björn Pasternak and Håkon K Gjessing and Siri E Håberg and Olof Stephansson},

doi = {10.1001/jama.2022.3271},

issn = {1538-3598},

year  = {2022},

date = {2022-04-01},

journal = {JAMA},

volume = {327},

number = {15},

pages = {1469--1477},

abstract = {IMPORTANCE: Data about the safety of vaccines against SARS-CoV-2 during pregnancy are limited.nnOBJECTIVE: To examine the risk of adverse pregnancy outcomes after vaccination against SARS-CoV-2 during pregnancy.nnDESIGN, SETTING, AND PARTICIPANTS: This registry-based retrospective cohort study included 157 521 singleton pregnancies ending after 22 gestational weeks from January 1, 2021, until January 12, 2022 (Sweden), or January 15, 2022 (Norway). The Pregnancy Register in Sweden and the Medical Birth Registry of Norway were linked to vaccination and other registries for identification of exposure and background characteristics.nnEXPOSURES: Data on mRNA vaccines-BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna)-and 1 viral vector vaccine-AZD1222 (AstraZeneca)-were collected from national vaccination registries.nnMAIN OUTCOMES AND MEASURES: The risk of preterm birth and stillbirth was evaluated using Cox regression models, with gestational day as the time metric and vaccination as a time-dependent exposure variable. The risk of small for gestational age, low Apgar score, and neonatal care admission was evaluated using logistic regression. Random-effects meta-analysis was used to combine results between countries.nnRESULTS: Among the 157 521 singleton births included in the study (103 409 in Sweden and 54 112 in Norway), the mean maternal age at the time of delivery was 31 years, and 28 506 (18%) were vaccinated against SARS-CoV-2 (12.9% with BNT162b2, 4.8% with mRNA-1273, and 0.3% with AZD1222) while pregnant. A total of 0.7%, 8.3%, and 9.1% of individuals delivering were vaccinated during the first, second, and third trimester, respectively. Vaccination against SARS-CoV-2 was not significantly associated with increased risk of preterm birth (6.2 vs 4.9 per 10 000 pregnancy days; adjusted hazard ratio [aHR], 0.98 [95% CI, 0.91 to 1.05]; I2 = 0%; P for heterogeneity = .60), stillbirth (2.1 vs 2.4 per 100 000 pregnancy days; aHR, 0.86 [95% CI, 0.63 to 1.17]), small for gestational age (7.8% vs 8.5%; difference, -0.6% [95% CI, -1.3% to 0.2%]; adjusted OR [aOR], 0.97 [95% CI, 0.90 to 1.04]), low Apgar score (1.5% vs 1.6%; difference, -0.05% [95% CI, -0.3% to 0.1%]; aOR, 0.97 [95% CI, 0.87 to 1.08]), or neonatal care admission (8.5% vs 8.5%; difference, 0.003% [95% CI, -0.9% to 0.9%]; aOR, 0.97 [95% CI, 0.86 to 1.10]).nnCONCLUSIONS AND RELEVANCE: In this population-based study conducted in Sweden and Norway, vaccination against SARS-CoV-2 during pregnancy, compared with no SARS-CoV-2 vaccination during pregnancy, was not significantly associated with an increased risk of adverse pregnancy outcomes. The majority of the vaccinations were with mRNA vaccines during the second and third trimesters of pregnancy, which should be considered in interpreting the findings.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34738703,

title = {The comparative cardiovascular and renal effectiveness of sodium-glucose co-transporter-2 inhibitors and glucagon-like peptide-1 receptor agonists: A Scandinavian cohort study},

author = {Peter Ueda and Viktor Wintzell and Elisabeth Dahlqwist and Björn Eliasson and Ann-Marie Svensson and Stefan Franzén and Soffia Gudbjörnsdottir and Kristian Hveem and Christian Jonasson and Mads Melbye and Anders Hviid and Henrik Svanström and Björn Pasternak},

doi = {10.1111/dom.14598},

issn = {1463-1326},

year  = {2022},

date = {2022-03-01},

journal = {Diabetes Obes Metab},

volume = {24},

number = {3},

pages = {473--485},

abstract = {AIM: To assess the comparative cardiovascular and renal effectiveness of sodium-glucose co-transporter-2 (SGLT2) inhibitors versus glucagon-like peptide-1 (GLP-1) receptor agonists in routine clinical practice.nnMATERIALS AND METHODS: A cohort study of nationwide registers from Sweden, Denmark, and Norway, including 87 525 new users of SGLT2 inhibitors and 63 921 new users of GLP-1 receptor agonists, was conducted using data from 2013-2018. Co-primary outcomes, analysed using an intention-to-treat exposure definition, were major adverse cardiovascular events (MACE; myocardial infarction, stroke, and cardiovascular death), heart failure (hospitalization or death because of heart failure), and serious renal events (renal replacement therapy, hospitalization for renal events, and death from renal causes).nnRESULTS: Use of SGLT2 inhibitors versus GLP-1 receptor agonists was associated with a higher risk of MACE (adjusted incidence rate: 15.2 vs. 14.4 events per 1000 person-years; HR 1.07 [95% CI 1.01-1.15]), a similar risk of heart failure (6.0 vs. 6.0 events per 1000 person-years; HR 1.02 [0.92-1.12]), and a lower risk of serious renal events (2.9 vs. 4.0 events per 1000 person-years; HR 0.76 [0.66-0.87]). In as-treated analyses, the HR (95% CI) was 1.11 (1.00-1.24) for MACE, 0.88 (0.74-1.04) for heart failure, and 0.60 (0.47-0.77) for serious renal events. In secondary outcome analyses, use of SGLT2 inhibitors versus GLP-1 receptor agonists was not associated with statistically significant differences for the risk of myocardial infarction (HR 1.09 [95% CI 1.00-1.19]), cardiovascular death (HR 0.97 [95% CI 0.84-1.12]), death from renal causes (HR 0.75 [95% CI 0.41-1.35]), or any cause death (HR 1.01 [95% CI 0.94-1.09]), while the risk of stroke was higher (HR 1.14 [95% CI 1.03-1.26]), and the risk of renal replacement therapy (HR 0.74 [95% CI 0.56-0.97]) and hospitalization for renal events (HR 0.75 [95% CI 0.65-0.88]) were lower among users of SGLT2 inhibitors.nnCONCLUSIONS: Use of SGLT2 inhibitors versus GLP-1 receptor agonists was associated with a similar risk of heart failure and a lower risk of serious renal events, while use of GLP-1 receptor agonists versus SGLT2 inhibitors was associated with a slightly lower risk of MACE. In as-treated analyses, the associations with MACE and serious renal events increased in magnitude, and the HR for heart failure tended towards a protective association for SGLT2 inhibitors.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35951607,

title = {Association between folic acid use during pregnancy and gestational diabetes mellitus: Two population-based Nordic cohort studies},

author = {Laura Pazzagli and Silvia Segovia Chacón and Christos Karampelias and Jacqueline M Cohen and Gabriella Bröms and Helle Kieler and Ingvild Odsbu and Randi Selmer and Olov Andersson and Carolyn E Cesta},

doi = {10.1371/journal.pone.0272046},

issn = {1932-6203},

year  = {2022},

date = {2022-01-01},

journal = {PLoS One},

volume = {17},

number = {8},

pages = {e0272046},

abstract = {INTRODUCTION: Inconsistent results have been reported on the association between folic acid use in pregnancy and risk of GDM. The aim of this study was to estimate the association between folic acid use and GDM in two population-based Nordic cohorts.nnMATERIAL AND METHODS: Two cohort studies were conducted using data from the national population registers in Norway (2005-2018, n = 791,709) and Sweden (2006-2016, n = 1,112,817). Logistic regression was used to estimate the associations between GDM and self-reported folic acid use and prescribed folic acid use, compared to non-users, adjusting for covariates. To quantify how potential unmeasured confounders may affect the estimates, E-values were reported. An exposure misclassification bias analysis was also performed.nnRESULTS: In Norwegian and Swedish cohorts, adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for maternal self-reported folic acid use were 1.10 (1.06-1.14) and 0.89 (0.85-0.93), with E-values of 1.43 (1.31) and 1.50 (1.36), respectively. For prescribed folic acid use, ORs were 1.33 (1.15-1.53) and 1.56 (1.41-1.74), with E-values of 1.99 (1.57) and 2.49 (2.17), in Norway and Sweden respectively.nnCONCLUSIONS: The slightly higher or lower odds for GDM in self-reported users of folic acid in Norway and Sweden respectively, are likely not of clinical relevance and recommendations for folic acid use in pregnancy should remain unchanged. The two Nordic cohorts showed different directions of the association between self-reported folic acid use and GDM, but based on bias analysis, exposure misclassification is an unlikely explanation since there may still be differences in prevalence of use and residual confounding. Prescribed folic acid is used by women with specific comorbidities and co-medications, which likely underlies the higher odds for GDM.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34611960,

title = {Pharmacological and epidemiological considerations while constructing treatment episodes using observational data: A simulation study},

author = {Laura Pazzagli and Morten Andersen and Maurizio Sessa},

doi = {10.1002/pds.5366},

issn = {1099-1557},

year  = {2022},

date = {2022-01-01},

journal = {Pharmacoepidemiol Drug Saf},

volume = {31},

number = {1},

pages = {55--60},

abstract = {BACKGROUND: The permissible gap method is an extensively used approach for defining episodes of continuous treatment use in pharmacoepidemiology. This method uses the amount of drug redeemed, when available, and researcher-defined temporal gaps to fill the interval between the calculated end of coverage of a redeemed prescription and the date of redemption of the next prescription in the same treatment episode. The final scope is defining periods of continuous use of medications. There are strong pharmacological and epidemiological arguments for adding the gap at the end of each treatment episode. However, the evidence is scarce on the impact that such a practice has on measures of association. This study aims to compare the impact of adding or not adding the researcher-defined gap time to the end of a treatment episode on the incidence of drug discontinuation and the incidence rate for a simulated outcome that occurred during an observational window. Additionally, the study aims at assessing the magnitude of misclassification of exposure time between the two methods.nnMETHODS: A simulated dataset of 100 patients available in the R package AdhereR that contains 1080 redeemed prescriptions was used. A gap time of 90 days was used for constructing treatment episodes in an observational window of 365 days following the first redeemed prescription. Two approaches were used for defining treatment episodes that were named "gap+" and "gap-" and that respectively add and did not add the gap time at the end of a treatment episode. An outcome was simulated by using an exponential baseline hazard function with scale parameter λ = 0.5 and censoring at time t = 365 days. The incidence rate ratio for the simulated outcome between the two approaches was computed.nnRESULTS: The 100 patients were followed for a median time of 183 days (interquartile range, IQR 50-365 days) and a median time of 273 days (IQR 140-365 days), respectively using "gap-" and "gap+". During the first 100 days of the follow-up period, none of the patients was found to discontinue the treatment with the method "gap+" while 38 patients discontinued using the method "gap-". The approach "gap+" exerted a higher incidence rate for the simulated outcome among the exposed (0.98 events/person-years) when compared to the "gap-" (0.82 events/person-years) during defined periods of continuous treatment use. When comparing the two approaches and using the method "gap-" as the reference group, the incidence rate ratio for the simulated outcome was 1.20 (95% confidence interval: CI 0.72-2.02) among the exposed.nnCONCLUSIONS: This study showed that not adding the gap at the end of the treatment episodes leads to an overestimation of drug discontinuation, particularly at the beginning of the observational window, and an underestimation of the incidence rate of a hypothetical outcome during the period of exposure to the medication.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34487407,

title = {Investigating the association between prenatal exposure to folic acid and risk of neonatal diabetes/hyperglycemia and type 1 diabetes: A Norwegian register-based study},

author = {Laura Pazzagli and Christos Karampelias and Randi Selmer and Olov Andersson and Carolyn E Cesta},

doi = {10.1111/pedi.13263},

issn = {1399-5448},

year  = {2021},

date = {2021-11-01},

journal = {Pediatr Diabetes},

volume = {22},

number = {7},

pages = {969--973},

abstract = {BACKGROUND: Experimental animal studies suggest a novel role for the folate receptor 1 in β-cell differentiation in the pancreas, with potential implications for glycemic control. We tested the hypothesis of a protective association between prenatal folic acid use and neonatal diabetes or hyperglycemia and type 1 diabetes in an observational cohort study using data from the national population health registers in Norway.nnMETHODS: All singleton pregnancies resulting in live births from 2005 to 2018 were identified. Prenatal exposure to folic acid was determined based on maternal report at antenatal care in early pregnancy. Diagnoses of neonatal diabetes, hyperglycemia, and type 1 diabetes for the children were identified. Associations were estimated with logistic regression or Cox proportional hazard model and included crude and adjusted estimates.nnRESULTS: Among 781,567 children, 69% had prenatal exposure to folic acid, 264 were diagnosed with neonatal diabetes or hyperglycemia, and 1390 with type 1 diabetes. Compared to children with no prenatal exposure to folic acid, children with prenatal exposure to folic acid had similar odds of having a neonatal diabetes or hyperglycemia diagnosis (adjusted odds ratio 0.95, 95% confidence interval [CI] 0.72, 1.25) and similar risk of being diagnosed with type 1 diabetes (adjusted hazard ratio 1.05, 95% CI 0.93, 1.18).nnCONCLUSIONS: No association between prenatal folic acid exposure and neonatal diabetes/hyperglycemia or type 1 diabetes was found. These findings do not rule out a translational effect of the experimental results and future studies with longer follow-up and more precise information on the window of prenatal exposure are needed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}