@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}

}

@article{pmid34453753,

title = {Use of sildenafil and other phosphodiesterase type 5 inhibitors among pregnant women in Scandinavia},

author = {Carolyn E Cesta and Silvia Segovia Chacón and Anders Engeland and Anne Broe and Per Damkier and Kari Furu and Helle Kieler and Pär Karlsson},

doi = {10.1111/aogs.14251},

issn = {1600-0412},

year  = {2021},

date = {2021-11-01},

journal = {Acta Obstet Gynecol Scand},

volume = {100},

number = {11},

pages = {2111--2118},

abstract = {INTRODUCTION: For phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, the only approved indication in women is for pulmonary arterial hypertension. These drugs are increasingly being proposed and tested for treatment of female infertility and complications in pregnancy. However, the extent of use of PDE5 inhibitors in the general pregnant population over the last decades is unknown. Therefore, we conducted a descriptive cohort study using data from the population health registers in the Scandinavian countries.nnMATERIAL AND METHODS: By linking the Medical Birth Registers and the Prescribed Drug Registers in Denmark (1997-2017), Norway (2004-2017), and Sweden (2006-2016), women with filled prescriptions of PDE5 inhibitors in outpatient settings in the 90 days before the date of last menstrual period and/or during pregnancies were identified. With additional linkage to the National Patient Registers, information on maternal, pregnancy, and infant characteristics, co-morbidities, and co-medication was collected and described.nnRESULTS: Among over 3 million singleton pregnancies, only 77 were pregnancies in women who had at least one filled prescription of a PDE5 inhibitor within the 90 days before the start of pregnancy to delivery. Prescription fills most often occurred before the last menstrual period and in the first trimester, with very few occurring later in pregnancy. Sildenafil was the most used PDE5 inhibitor. Among pregnant women using PDE5 inhibitors, 44% were 35 years of age or older, eight had a cardiovascular diagnosis, and three specifically had a diagnosis of pulmonary arterial hypertension. Among the infants born to mothers using PDE5 inhibitors, nine were born preterm, six were small-for-gestational age, five had an Apgar score at 5 minutes below 8, 18 were admitted to the Neonatal Intensive Care Unit, and eight had respiratory and cardiovascular conditions.nnCONCLUSIONS: Few women used PDE5 inhibitors in outpatient settings before or during pregnancy in the Scandinavian countries in the last decades. Only a small proportion had a diagnosis for pulmonary arterial hypertension, suggesting off-label use in the remaining users. Use was predominantly in mothers over age 35 years. The safety of fetal exposure to sildenafil and other PDE5 inhibitors in pregnancy has not been established. As maternal age continues to increase and additional uses of PDE5 inhibitors are investigated, the safety of these drugs in pregnancy should be thoroughly evaluated.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid33871080,

title = {Use of non-insulin antidiabetic drugs in children and young adults - A Scandinavian drug utilization study from 2010-2019},

author = {Helene K Jensen and Lotte Rasmussen and Kari Furu and Øystein Karlstad and Marie Linder and Carolyn E Cesta and Anton Pottegård},

doi = {10.1111/bcp.14867},

issn = {1365-2125},

year  = {2021},

date = {2021-11-01},

journal = {Br J Clin Pharmacol},

volume = {87},

number = {11},

pages = {4470--4475},

abstract = {Knowledge on utilization patterns of non-insulin antidiabetic drugs in childhood and youth is limited. Therefore, we conducted a population-based drug utilization study using publicly available aggregate data on use of non-insulin antidiabetics from 2010 to 2019 in Scandinavia (Denmark, Norway and Sweden) in individuals aged up to 24 years. For each non-insulin antidiabetic drug, we calculated the annual prevalence proportion of users, overall and for specific age groups. From 2010 to 2019, the prevalence of non-insulin antidiabetic users in Scandinavia increased 37% from 0.43 to 0.59/1000 individuals. The prevalence proportions were highest among female adolescents and young adults, but the largest relative increase in use was seen among 10-14-year-olds (78%). Metformin was by far the most widely used non-insulin antidiabetic drug with a prevalence proportion of 0.51/1000 in 2019, followed by glucagon-like peptide-1 (GLP-1) analogues, which, however, showed an eight-fold relative increase during the study period.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34017981,

title = {Maternal Medication Use and Childhood Cancer in Offspring-Systematic Review and Considerations for Researchers},

author = {Sarah Hjorth and Caroline H Hemmingsen and Justine Bénévent and Anne Broe and Anton Pottegaard and Lina S Mørch and Maarit K Leinonen and Susanne K Kjaer and Marie Hargreave and Hedvig Nordeng},

doi = {10.1093/aje/kwab154},

issn = {1476-6256},

year  = {2021},

date = {2021-11-01},

journal = {Am J Epidemiol},

volume = {190},

number = {11},

pages = {2487--2499},

abstract = {Cancer is an important cause of childhood mortality, yet the etiology is largely unknown. A combination of pre- and postnatal factors is thought to be implicated, including maternal medication use. We aimed to provide: 1) a systematic review of peer-reviewed publications on associations between maternal medication use and childhood cancer, with a focus on study design and methodology; and 2) suggestions for how to increase transparency, limit potential biases, and improve comparability in studies on maternal medication use and childhood cancer. We conducted a systematic search in the PubMed, Embase, Scopus, Cochrane, and Web of Science databases to June 8, 2020. Altogether, 112 studies were identified. The reviewed studies were heterogeneous in study design, exposure, and outcome classification. In 21 studies (19%), the outcome was any childhood cancer. Of the 91 papers that reported on specific types of cancer, 62% did not report the cancer classification system. The most frequently investigated medication groups were sex hormones (46 studies, excluding fertility medications), and antiinfectives (37 studies). Suggestions for strengthening future pharmacoepidemiologic studies on maternal medication use and childhood cancer relate to choice of cancer classification system, exposure windows, and methods for identification of, and control for, potential confounders.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34254177,

title = {Use of incretin-based drugs and risk of cholangiocarcinoma: Scandinavian cohort study},

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

doi = {10.1007/s00125-021-05508-1},

issn = {1432-0428},

year  = {2021},

date = {2021-10-01},

journal = {Diabetologia},

volume = {64},

number = {10},

pages = {2204--2214},

abstract = {AIMS/HYPOTHESIS: Concerns have been raised regarding a potential association of use of the incretin-based drugs dipeptidyl peptidase 4 (DPP4) inhibitors and glucagon-like peptide-1 (GLP-1)-receptor agonists with risk of cholangiocarcinoma. We examined this association in nationwide data from three countries.nnMETHODS: We used data from nationwide registers in Sweden, Denmark and Norway, 2007-2018, to conduct two cohort studies, one for DPP4 inhibitors and one for GLP-1-receptor agonists, to investigate the risk of incident cholangiocarcinoma compared with an active-comparator drug class (sulfonylureas). The cohorts included patients initiating treatment episodes with DPP4 inhibitors vs sulfonylureas, and GLP-1-receptor agonists vs sulfonylureas. We used Cox regression models, adjusted for potential confounders, to estimate hazard ratios from day 366 after treatment initiation to account for cancer latency.nnRESULTS: The main analyses of DPP4 inhibitors included 1,414,144 person-years of follow-up from 222,577 patients receiving DPP4 inhibitors (median [IQR] follow-up time, 4.5 [2.6-7.0] years) and 123,908 patients receiving sulfonylureas (median [IQR] follow-up time, 5.1 [2.9-7.8] years) during which 350 cholangiocarcinoma events occurred. Use of DPP4 inhibitors, compared with sulfonylureas, was not associated with a statistically significant increase in risk of cholangiocarcinoma (incidence rate 26 vs 23 per 100,000 person-years; adjusted HR, 1.15 [95% CI 0.90, 1.46]; absolute rate difference 3 [95% CI -3, 10] events per 100,000 person-years). The main analyses of GLP-1-receptor agonists included 1,036,587 person-years of follow-up from 96,813 patients receiving GLP-1-receptor agonists (median [IQR] follow-up time, 4.4 [2.4-6.9] years) and 142,578 patients receiving sulfonylureas (median [IQR] follow-up time, 5.5 [3.2-8.1] years) during which 249 cholangiocarcinoma events occurred. Use of GLP-1-receptor agonists was not associated with a statistically significant increase in risk of cholangiocarcinoma (incidence rate 26 vs 23 per 100,000 person-years; adjusted HR, 1.25 [95% CI 0.89, 1.76]; absolute rate difference 3 [95% CI -5, 13] events per 100,000 patient-years).nnCONCLUSIONS/INTERPRETATION: In this analysis using nationwide data from three countries, use of DPP4 inhibitors and GLP-1-receptor agonists, compared with sulfonylureas, was not associated with a significantly increased risk of cholangiocarcinoma.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Cohen2021,

title = {A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS)},

author = {Jacqueline M. Cohen and Carolyn E. Cesta and Lars Kjerpeseth and Maarit K. Leinonen and Óskar Hálfdánarson and Øystein Karlstad and Pär Karlsson and Morten Andersen and Kari Furu and Vidar Hjellvik},

doi = {10.5324/nje.v29i1-2.4053},

issn = {0803-2491},

year  = {2021},

date = {2021-08-16},

journal = {Nor J Epidemiol},

volume = {29},

number = {1-2},

publisher = {Norwegian University of Science and Technology (NTNU) Library},

abstract = {It is necessary to carry out large observational studies to generate robust evidence about the safety of drugs used during pregnancy. In the Nordic countries, nationwide population-based health registers that document all births and dispensed prescribed drugs are valuable resources for such studies. A common data model (CDM) is a data harmonization and structuring tool that enables a unified and streamlined analytic approach for studies including data from multiple countries or databases. We describe a CDM developed for the Nordic Pregnancy Drug Safety Studies (NorPreSS), including details on data sources and structure of the data tables. We also provide an overview of the advantages and disadvantages of the approach (e.g. sharing of data analysis programs versus extra initial work to create CDM datasets from raw data).},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34236595,

title = {Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study},

author = {Veena Hoffman and Jesper Hallas and Marie Linder and Andrea V Margulis and Brandon T Suehs and Alejandro Arana and Kelesitse Phiri and Cheryl Enger and Libby Horter and Ingvild Odsbu and Morten Olesen and Susana Perez-Gutthann and Yihua Xu and Nina Sahlertz Kristiansen and Kwame Appenteng and Stefan de Vogel and John D Seeger and },

doi = {10.1007/s40264-021-01095-7},

issn = {1179-1942},

year  = {2021},

date = {2021-08-01},

journal = {Drug Saf},

volume = {44},

number = {8},

pages = {899--915},

abstract = {INTRODUCTION: During clinical trials, mirabegron, a β3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder.nnOBJECTIVE: The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use.nnMETHODS: We conducted an observational post-marketing safety study utilising real-world data. The study population was identified within five sources: Danish and Swedish National Registers, Clinical Practice Research Datalink (UK), Optum (USA) and Humana (USA). Episodes of time when patients were new users of mirabegron or antimuscarinics (October 2012-December 2018) were sourced from prescriptions and matched on propensity scores. Occurrences of major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, CV mortality and all-cause mortality were identified. Outcome incidence rates and hazard ratios from Cox models were estimated.nnRESULTS: Overall, 152,026 mirabegron and 152,026 antimuscarinic episodes were matched. The population consisted of 63.1% women and 72.6% were ≥ 65 years old. There were no appreciable differences in the incidence rates of MACE, AMI or stroke between users of mirabegron and antimuscarinics. Incidence rates of CV mortality (hazard ratio 0.83, 95% confidence interval 0.73-0.95) and all-cause mortality (hazard ratio 0.80, 95% confidence interval 0.76-0.84) were no higher with mirabegron vs antimuscarinics. Results restricted to episodes at high risk for CV events or stratified by age (< 65 years, ≥ 65 years) or prior overactive bladder medication use were consistent with overall findings.nnCONCLUSIONS: This large, multinational study found no higher risk of MACE, AMI, stroke, CV mortality or all-cause mortality among users of mirabegron relative to users of antimuscarinics.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid34021908,

title = {Use of hypnotic drugs among children, adolescents, and young adults in Scandinavia},

author = {Rikke Wesselhoeft and Lotte Rasmussen and Peter Bjødstrup Jensen and Poul Jørgen Jennum and Svetlana Skurtveit and Ingeborg Hartz and Johan Reutfors and Per Damkier and Mette Bliddal and Anton Pottegård},

doi = {10.1111/acps.13329},

issn = {1600-0447},

year  = {2021},

date = {2021-08-01},

journal = {Acta Psychiatr Scand},

volume = {144},

number = {2},

pages = {100--112},

abstract = {BACKGROUND: Hypnotic use in children and adolescents is controversial.nnOBJECTIVE: To describe the use of hypnotic drugs (melatonin, z-drugs, and sedating antihistamines) among 5- to 24-year-old Scandinavians during 2012 to 2018.nnMETHODS: Aggregate-level data were obtained from public data sources in Sweden, Norway, and Denmark. We calculated annual prevalence (users/1000 inhabitants) stratified by age group, sex, and country. Quantity of use (Defined Daily Dose (DDD)/user/day) was estimated for Norway and Denmark.nnRESULTS: Melatonin was the most commonly used hypnotic, and its use increased markedly from 2012 to 2018, particularly among females and 15- to 24-year-old individuals. Sweden had the highest increase in use (6.5 to 25/1000) compared with Norway (10-20/1000) and Denmark (5.7-12/1000). The annual prevalence of sedating antihistamine use was also highest in Sweden, reaching 13/1000 in 2018 in comparison to 7.5/1000 in Norway and 2.5/1000 in Denmark. Z-drug use decreased in all countries toward 2018, dropping to 3.5/1000 in Sweden, 4.4/1000 in Norway, and 1.7/1000 in Denmark. The quantity of hypnotic use in Norway and Denmark was 0.8-1.0 DDD/user/day for melatonin in 2018, as compared to 0.1-0.3 for z-drugs and antihistamines.nnCONCLUSION: The use of melatonin and sedating antihistamines increased among young Scandinavians during 2012-2018, and the increase was twice as high in Sweden compared with Norway and Denmark. In addition, Sweden had the highest use of sedating antihistamines. The Scandinavian variation of hypnotic use could reflect differences in frequency of sleep problems between populations or variation of healthcare access or clinical practice between countries.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Laugesen2021,

title = {Nordic Health Registry-Based Research: A Review of Health Care Systems and Key Registries},

author = {Kristina Laugesen and Jonas F Ludvigsson and Morten Schmidt and Mika Gissler and Unnur Anna Valdimarsdottir and Astrid Lunde and Henrik Toft Sørensen},

doi = {10.2147/clep.s314959},

issn = {1179-1349},

year  = {2021},

date = {2021-07-00},

journal = {CLEP},

volume = {Volume 13},

pages = {533--554},

publisher = {Informa UK Limited},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid33952445,

title = {Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study},

author = {Anton Pottegård and Lars Christian Lund and Øystein Karlstad and Jesper Dahl and Morten Andersen and Jesper Hallas and Øjvind Lidegaard and German Tapia and Hanne Løvdal Gulseth and Paz Lopez-Doriga Ruiz and Sara Viksmoen Watle and Anders Pretzmann Mikkelsen and Lars Pedersen and Henrik Toft Sørensen and Reimar Wernich Thomsen and Anders Hviid},

doi = {10.1136/bmj.n1114},

issn = {1756-1833},

year  = {2021},

date = {2021-05-01},

journal = {BMJ},

volume = {373},

pages = {n1114},

abstract = {OBJECTIVE: To assess rates of cardiovascular and haemostatic events in the first 28 days after vaccination with the Oxford-AstraZeneca vaccine ChAdOx1-S in Denmark and Norway and to compare them with rates observed in the general populations.nnDESIGN: Population based cohort study.nnSETTING: Nationwide healthcare registers in Denmark and Norway.nnPARTICIPANTS: All people aged 18-65 years who received a first vaccination with ChAdOx1-S from 9 February 2021 to 11 March 2021. The general populations of Denmark (2016-18) and Norway (2018-19) served as comparator cohorts.nnMAIN OUTCOME MEASURES: Observed 28 day rates of hospital contacts for incident arterial events, venous thromboembolism, thrombocytopenia/coagulation disorders, and bleeding among vaccinated people compared with expected rates, based on national age and sex specific background rates from the general populations of the two countries.nnRESULTS: The vaccinated cohorts comprised 148 792 people in Denmark (median age 45 years, 80% women) and 132 472 in Norway (median age 44 years, 78% women), who received their first dose of ChAdOx1-S. Among 281 264 people who received ChAdOx1-S, the standardised morbidity ratio for arterial events was 0.97 (95% confidence interval 0.77 to 1.20). 59 venous thromboembolic events were observed in the vaccinated cohort compared with 30 expected based on the incidence rates in the general population, corresponding to a standardised morbidity ratio of 1.97 (1.50 to 2.54) and 11 (5.6 to 17.0) excess events per 100 000 vaccinations. A higher than expected rate of cerebral venous thrombosis was observed: standardised morbidity ratio 20.25 (8.14 to 41.73); an excess of 2.5 (0.9 to 5.2) events per 100 000 vaccinations. The standardised morbidity ratio for any thrombocytopenia/coagulation disorders was 1.52 (0.97 to 2.25) and for any bleeding was 1.23 (0.97 to 1.55). 15 deaths were observed in the vaccine cohort compared with 44 expected.nnCONCLUSIONS: Among recipients of ChAdOx1-S, increased rates of venous thromboembolic events, including cerebral venous thrombosis, were observed. For the remaining safety outcomes, results were largely reassuring, with slightly higher rates of thrombocytopenia/coagulation disorders and bleeding, which could be influenced by increased surveillance of vaccine recipients. The absolute risks of venous thromboembolic events were, however, small, and the findings should be interpreted in the light of the proven beneficial effects of the vaccine, the context of the given country, and the limitations to the generalisability of the study findings.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Mahic2020,

title = {In utero opioid exposure and risk of infections in childhood: A multinational Nordic cohort study},

author = {Milada Mahic and Sonia Hernandez‐Diaz and Mollie Wood and Helle Kieler and Ingvild Odsbu and Mette Nørgaard and Buket Öztürk and Brian T. Bateman and Vidar Hjellvik and Svetlana Skurtveit and Marte Handal},

doi = {10.1002/pds.5088},

issn = {1099-1557},

year  = {2020},

date = {2020-12-00},

journal = {Pharmacoepidemiology and Drug},

volume = {29},

number = {12},

pages = {1596--1604},

publisher = {Wiley},

abstract = {AbstractPurposeThere is an increasing number of children with in utero exposure to opioids. Knowledge about opioid safety in pregnancy, particularly for outcomes later in childhood is scarce. It has been suggested that opioids can modulate immune system and increase the risk of infections. Our goal was to study the impact of in utero opioid exposure on the immune system and the risk of infections in childhood.MethodsThis population‐based cohort study used nationwide registers from Denmark, Norway, and Sweden. Among pregnant women we identified users of opioids for two different indications, opioids used in opioid maintenance therapy (OMT) and opioids used for treatment of pain. We followed the exposed children and studied susceptibility for infections measured as number of antibiotic prescriptions expressed as Incidence rate ratios (IRRs) and diagnoses in specialist health care expressed as hazard ratios (HRs).ResultsAfter adjustment we did not observe increased risk for filling antibiotic prescriptions in children exposed to OMT opioids compared with OMT discontinuers (IRR, 1.08; 95% CI 0.81‐1.44 in Norway and Sweden, and IRR, 0.74; 95% CI 0.63‐0.88 in Denmark), or for diagnosis of infection in specialist health care (HR 0.83; 95% CI 0.55‐1.26 in Norway and Sweden, and 0.82; 95% CI 0.62‐1.10 in Denmark).ConclusionsIn this population‐based cohort study, we did not observe increased risk of infections among children prenatally exposed to OMT opioids when compared to OMT discontinuers, nor long‐term analgesic opioids exposed when compared to short‐term analgesic opioids exposed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Cohen2020,

title = {Prevalence trends and individual patterns of antiepileptic drug use in pregnancy 2006‐2016: A study in the five Nordic countries, United States, and Australia},

author = {Jacqueline M. Cohen and Carolyn E. Cesta and Kari Furu and Kristjana Einarsdóttir and Mika Gissler and Alys Havard and Sonia Hernandez‐Diaz and Krista F. Huybrechts and Helle Kieler and Maarit K. Leinonen and Jiong Li and Johan Reutfors and Andrea Schaffer and Randi Selmer and Yongfu Yu and Helga Zoega and Øystein Karlstad},

doi = {10.1002/pds.5035},

issn = {1099-1557},

year  = {2020},

date = {2020-08-00},

journal = {Pharmacoepidemiology and Drug},

volume = {29},

number = {8},

pages = {913--922},

publisher = {Wiley},

abstract = {AbstractPurposeTo describe recent international trends in antiepileptic drug (AED) use during pregnancy and individual patterns of use including discontinuation and switching.MethodsWe studied pregnancies from 2006 to 2016 within linked population‐based registers for births and dispensed prescription drugs from Denmark, Finland, Iceland, Norway, Sweden, and New South Wales, Australia and claims data for public and private insurance enrollees in the United States. We examined the prevalence of AED use: the proportion of pregnancies with ≥1 prescription filled from 3 months before pregnancy until birth, and individual patterns of use by trimester.ResultsPrevalence of AED use in almost five million pregnancies was 15.3 per 1000 (n = 75 249) and varied from 6.4 in Sweden to 34.5 per 1000 in the publicly‐insured US population. AED use increased in all countries in 2006‐2012 ranging from an increase of 22% in Australia to 104% in Sweden, and continued to rise or stabilized in the countries in which more recent data were available. Lamotrigine, clonazepam, and valproate were the most commonly used AEDs in the Nordic countries, United States, and Australia, respectively. Among AED users, 31% only filled a prescription in the 3 months before pregnancy. Most filled a prescription in the first trimester (59%) but few filled prescriptions in every trimester (22%).ConclusionsUse of AEDs in pregnancy rose from 2006 to 2016. Trends and patterns of use of valproate and lamotrigine reflected the safety data available during this period. Many women discontinued AEDs during pregnancy while some switched to another AED.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Cohen2020b,

title = {Prevalence trends and individual patterns of antiepileptic drug use in pregnancy 2006‐2016: A study in the five Nordic countries, United States, and Australia},

author = {Jacqueline M. Cohen and Carolyn E. Cesta and Kari Furu and Kristjana Einarsdóttir and Mika Gissler and Alys Havard and Sonia Hernandez‐Diaz and Krista F. Huybrechts and Helle Kieler and Maarit K. Leinonen and Jiong Li and Johan Reutfors and Andrea Schaffer and Randi Selmer and Yongfu Yu and Helga Zoega and Øystein Karlstad},

doi = {10.1002/pds.5035},

issn = {1099-1557},

year  = {2020},

date = {2020-08-00},

journal = {Pharmacoepidemiology and Drug},

volume = {29},

number = {8},

pages = {913--922},

publisher = {Wiley},

abstract = {AbstractPurposeTo describe recent international trends in antiepileptic drug (AED) use during pregnancy and individual patterns of use including discontinuation and switching.MethodsWe studied pregnancies from 2006 to 2016 within linked population‐based registers for births and dispensed prescription drugs from Denmark, Finland, Iceland, Norway, Sweden, and New South Wales, Australia and claims data for public and private insurance enrollees in the United States. We examined the prevalence of AED use: the proportion of pregnancies with ≥1 prescription filled from 3 months before pregnancy until birth, and individual patterns of use by trimester.ResultsPrevalence of AED use in almost five million pregnancies was 15.3 per 1000 (n = 75 249) and varied from 6.4 in Sweden to 34.5 per 1000 in the publicly‐insured US population. AED use increased in all countries in 2006‐2012 ranging from an increase of 22% in Australia to 104% in Sweden, and continued to rise or stabilized in the countries in which more recent data were available. Lamotrigine, clonazepam, and valproate were the most commonly used AEDs in the Nordic countries, United States, and Australia, respectively. Among AED users, 31% only filled a prescription in the 3 months before pregnancy. Most filled a prescription in the first trimester (59%) but few filled prescriptions in every trimester (22%).ConclusionsUse of AEDs in pregnancy rose from 2006 to 2016. Trends and patterns of use of valproate and lamotrigine reflected the safety data available during this period. Many women discontinued AEDs during pregnancy while some switched to another AED.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Reutfors2020,

title = {Antipsychotic drug use in pregnancy: A multinational study from ten countries},

author = {Johan Reutfors and Carolyn E. Cesta and Jacqueline M. Cohen and Brian T. Bateman and Ruth Brauer and Kristjana Einarsdóttir and Anders Engeland and Kari Furu and Mika Gissler and Alys Havard and Sonia Hernandez-Diaz and Krista F. Huybrechts and Øystein Karlstad and Maarit K. Leinonen and Jiong Li and Kenneth K.C. Man and Laura Pazzagli and Andrea Schaffer and Tania Schink and Zixuan Wang and Yongfu Yu and Helga Zoega and Gabriella Bröms},

doi = {10.1016/j.schres.2020.03.048},

issn = {0920-9964},

year  = {2020},

date = {2020-06-00},

journal = {Schizophrenia Research},

volume = {220},

pages = {106--115},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bröms2020,

title = {Anti‐TNF treatment during pregnancy and birth outcomes: A population‐based study from Denmark, Finland, and Sweden},

author = {Gabriella Bröms and Helle Kieler and Anders Ekbom and Mika Gissler and Karin Hellgren and Anna‐Maria Lahesmaa‐Korpinen and Lars Pedersen and Marcus Schmitt‐Egenolf and Henrik T. Sørensen and Fredrik Granath},

doi = {10.1002/pds.4930},

issn = {1099-1557},

year  = {2020},

date = {2020-03-00},

journal = {Pharmacoepidemiology and Drug},

volume = {29},

number = {3},

pages = {316--327},

publisher = {Wiley},

abstract = {AbstractPurposeTo study the risk of preterm birth, caesarean section, and small for gestational age after anti‐tumor necrosis factor agent treatment (anti‐TNF) in pregnancy.MethodsPopulation‐based study including women with inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, and their infants born 2006 to 2013 from the national health registers in Denmark, Finland, and Sweden. Women treated with anti‐TNF were compared with women with nonbiologic systemic treatment. Adalimumab, etanercept, and infliximab were compared pairwise. Continuation of treatment in early pregnancy was compared with discontinuation. Odds ratios with 95% confidence intervals were calculated in logistic regression models adjusted for country and maternal characteristics.ResultsAmong 1 633 909 births, 1027 infants were to women treated with anti‐TNF and 9399 to women with nonbiologic systemic treatment. Compared with non‐biologic systemic treatment, women with anti‐TNF treatment had a higher risk of preterm birth, odds ratio 1.61 (1.29‐2.02) and caesarean section, 1.57 (1.35‐1.82). The odds ratio for small for gestational age was 1.36 (0.96‐1.92). In pairwise comparisons, infliximab was associated with a higher risk of severely small for gestational age for inflammatory joint and skin diseases but not for inflammatory bowel disease. Discontinuation of anti‐TNF had opposite effects on preterm birth for inflammatory bowel disease and inflammatory joint and skin diseases.ConclusionsAnti‐TNF agents were associated with increased risks of preterm birth, caesarean section, and small for gestational age. However, the diverse findings across disease groups may indicate an association related to the underlying disease activity, rather than to agent‐specific effects.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Pedersen2019,

title = {Risk of adverse birth outcomes after maternal varenicline use: A population‐based observational study in Denmark and Sweden},

author = {Lars Pedersen and Kenneth R. Petronis and Mette Nørgaard and Jingping Mo and Trine Frøslev and Olof Stephansson and Fredrik Granath and Helle Kieler and Henrik Toft Sørensen},

doi = {10.1002/pds.4894},

issn = {1099-1557},

year  = {2020},

date = {2020-01-00},

journal = {Pharmacoepidemiology and Drug},

volume = {29},

number = {1},

pages = {94--102},

publisher = {Wiley},

abstract = {AbstractPurposeTo examine risks of adverse birth outcomes in women exposed to varenicline during pregnancy.MethodsPopulation‐based cohort study including live‐born and stillborn infants from 1 May 2007 to 31 December 2012. Data from health and administrative registries in Denmark and Sweden, two Nordic countries with universal health care and routine registration of major life and health events. Infants were allocated to three cohorts on the basis of their in utero exposure: the exposed cohort consisting of infants whose mothers were dispensed varenicline during pregnancy; the unexposed cohort comprised infants unexposed to varenicline, but exposed to maternal smoking in utero; and the reference cohort of infants unexposed to varenicline and maternal smoking in utero.The primary outcome was major congenital malformations diagnosed from birth to the first year of life. Secondary outcomes included stillbirth, fetal growth restriction (measured as small for gestational age), preterm delivery, preterm premature rupture of membranes, and sudden infant death syndrome. We estimated the prevalence of the primary outcome and secondary outcomes in the exposed, unexposed, and reference cohorts. Prevalence odds ratios with 95% confidence intervals (CIs) were computed using logistic regression with propensity score adjustment to control for potential confounders.ResultsThe combined cohort included 885 185 infants. Of these, 335 infants were exposed, 78 412 were unexposed, and the remaining 806 438 comprised the reference cohort. Major congenital malformations were detected among 3.6% of exposed infants, 4.3% of unexposed infants, and 4.2% of infants in the reference cohort. The propensity score–adjusted prevalence odds ratio for major congenital malformations was 0.80 (95% CI, 0.45‐1.42) for exposed vs unexposed infants. All analyses of primary and secondary outcomes comparing exposed with unexposed infants yielded odds ratio estimates below or close to unity.Use of varenicline during pregnancy does not appear to increase the risk of major congenital malformations or other adverse birth outcomes.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Wesselhoeft2019,

title = {Trends in antidepressant use among children and adolescents: a Scandinavian drug utilization study},

author = {R. Wesselhoeft and P. B. Jensen and A. Talati and J. Reutfors and K. Furu and K. Strandberg‐Larsen and P. Damkier and A. Pottegård and M. Bliddal},

doi = {10.1111/acps.13116},

issn = {1600-0447},

year  = {2020},

date = {2020-01-00},

journal = {Acta Psychiatr Scand},

volume = {141},

number = {1},

pages = {34--42},

publisher = {Wiley},

abstract = {ObjectiveTo compare antidepressant utilization in individuals aged 5–19 years from the Scandinavian countries.MethodsA population‐based drug utilization study using publicly available data of antidepressant use from Denmark, Norway, and Sweden.ResultsIn the study period from 2007 to 2017, the proportion of antidepressant users increased markedly in Sweden (9.3–18.0/1000) compared to Norway (5.1–7.6/1000) and Denmark (9.3–7.5/1000). In 2017, the cumulated defined daily doses (DDD) of selective serotonin reuptake inhibitors were 5611/1000 inhabitants in Sweden, 2709/1000 in Denmark, and 1848/1000 in Norway. The use of ‘other antidepressants' (ATC code N06AX) also increased in Sweden with a higher DDD in 2017 (497/1000) compared to Denmark (225/1000) and Norway (170/1000). The use of tricyclic antidepressants was generally low in 2017 with DDDs ranging between 30–42 per 1000. The proportion of antidepressant users was highest among 15‐ to 19‐year‐old individuals. Girls were more likely to receive treatment than boys, and the treated female/male ratios per 1000 were similar in Sweden (2.39), Denmark (2.44), and Norway (2.63).ConclusionEven in highly comparable healthcare systems like the Scandinavian countries', variation in antidepressant use is considerable. Swedish children and adolescents have a markedly higher and still increasing use of antidepressants compared to Danish and Norwegian peers.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Cesta2019,

title = {Antidiabetic medication use during pregnancy: an international utilization study},

author = {Carolyn E Cesta and Jacqueline M Cohen and Laura Pazzagli and Brian T Bateman and Gabriella Bröms and Kristjana Einarsdóttir and Kari Furu and Alys Havard and Anna Heino and Sonia Hernandez-Diaz and Krista F Huybrechts and Øystein Karlstad and Helle Kieler and Jiong Li and Maarit K Leinonen and Hanne L Gulseth and Duong Tran and Yongfu Yu and Helga Zoega and Ingvild Odsbu},

doi = {10.1136/bmjdrc-2019-000759},

issn = {2052-4897},

year  = {2019},

date = {2019-11-00},

journal = {BMJ Open Diab Res Care},

volume = {7},

number = {1},

publisher = {BMJ},

abstract = {ObjectiveDiabetes in pregnancy and consequently the need for treatment with antidiabetic medication (ADM) has become increasingly prevalent. The prevalence and patterns of use of ADM in pregnancy from 2006 onward in seven different countries was assessed.Research design and methodsData sources included individually linked data from the nationwide health registers in Denmark (2006–2016), Finland (2006–2016), Iceland (2006–2012), Norway (2006–2015), Sweden (2006–2015), state-wide administrative and claims data for New South Wales, Australia (2006–2012) and two US insurance databases: Medicaid Analytic eXtract (MAX; 2006–2012, public) and IBM MarketScan (2012–2015, private). The prevalence of ADM use was calculated as the proportion of pregnancies with at least one filled prescription of an ADM in the 90 days before pregnancy or within the three trimesters of pregnancy.ResultsPrevalence of any ADM use in 5 279 231 pregnancies was 3% (n=147 999) and varied from under 2% (Denmark, Norway, and Sweden) to above 5% (Australia and US). Insulin was the most used ADM, and metformin was the most used oral hypoglycemic agent with increasing use over time in all countries. In 11.4%–62.5% of pregnancies with prepregnancy use, ADM (primarily metformin) was discontinued. When ADM treatment was initiated in late pregnancy for treatment of gestational diabetes mellitus, insulin was most often dispensed, except in the US, where glibenclamide was most often used.ConclusionsPrevalence and patterns of use of ADM classes varied between countries and over time. While insulin remained the most common ADM used in pregnancy, metformin use increased significantly over the study period.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Højlund2019,

title = {Trends in utilization and dosing of antipsychotic drugs in Scandinavia: Comparison of 2006 and 2016},

author = {Mikkel Højlund and Anton Pottegård and Erik Johnsen and Rune A. Kroken and Johan Reutfors and Povl Munk‐Jørgensen and Christoph U. Correll},

doi = {10.1111/bcp.13945},

issn = {1365-2125},

year  = {2019},

date = {2019-07-00},

journal = {Brit J Clinical Pharma},

volume = {85},

number = {7},

pages = {1598--1606},

publisher = {Wiley},

abstract = {AimsThe aim of this study was to investigate time trends in dosing and prevalence of antipsychotic prescriptions in Scandinavia.MethodsWe retrieved data on antipsychotic use between 2006 and 2016 from Danish, Norwegian and Swedish national prescription registers. For each antipsychotic, we calculated prevalence of use and mean doses, overall and for specific age groups (young, adults and elderly).ResultsAntipsychotic use in Scandinavia increased from 16.5 to 17.2 users/1000 inhabitants between 2006 and 2016 (+2.4%, annual change: 0.07 users/1000 inhabitants/year, 95% CI: 0.02–0.20, P = 0.02). In 2006, chlorprothixene and levomepromazine were the most commonly used antipsychotics. By 2016, quetiapine was the most used antipsychotic in all three countries and across all age groups, with an overall 1‐year prevalence of 4.05–9.97 users/1000 inhabitants (annual change: 0.57 users/1000 inhabitants/year, 95% CI: 0.54–0.60, P < 0.001). Quetiapine showed a marked decrease in mean doses during the 11‐year study period (0.46–0.28 defined daily doses (DDD)/user/day: 39.1%, −0.02 DDD/user/day/year, 95% CI: −0.020 to −0.015, P < 0.001). In 2016, the highest mean doses were seen for clozapine (0.90–1.07 DDD/user/day) and olanzapine (0.66–0.88 DDD/user/day).ConclusionsThere is an increased prevalence of antipsychotic prescriptions that coincides with low and/or decreasing mean doses of the majority of commonly used antipsychotics in Scandinavia. Of all antipsychotics, this development was most pronounced for quetiapine. Reasons for and consequences of increased antipsychotic use that lasts shorter periods of time requires further study.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Højlund2019b,

title = {Trends in utilization and dosing of antipsychotic drugs in Scandinavia: Comparison of 2006 and 2016},

author = {Mikkel Højlund and Anton Pottegård and Erik Johnsen and Rune A. Kroken and Johan Reutfors and Povl Munk‐Jørgensen and Christoph U. Correll},

doi = {10.1111/bcp.13945},

issn = {1365-2125},

year  = {2019},

date = {2019-07-00},

journal = {Brit J Clinical Pharma},

volume = {85},

number = {7},

pages = {1598--1606},

publisher = {Wiley},

abstract = {AimsThe aim of this study was to investigate time trends in dosing and prevalence of antipsychotic prescriptions in Scandinavia.MethodsWe retrieved data on antipsychotic use between 2006 and 2016 from Danish, Norwegian and Swedish national prescription registers. For each antipsychotic, we calculated prevalence of use and mean doses, overall and for specific age groups (young, adults and elderly).ResultsAntipsychotic use in Scandinavia increased from 16.5 to 17.2 users/1000 inhabitants between 2006 and 2016 (+2.4%, annual change: 0.07 users/1000 inhabitants/year, 95% CI: 0.02–0.20, P = 0.02). In 2006, chlorprothixene and levomepromazine were the most commonly used antipsychotics. By 2016, quetiapine was the most used antipsychotic in all three countries and across all age groups, with an overall 1‐year prevalence of 4.05–9.97 users/1000 inhabitants (annual change: 0.57 users/1000 inhabitants/year, 95% CI: 0.54–0.60, P < 0.001). Quetiapine showed a marked decrease in mean doses during the 11‐year study period (0.46–0.28 defined daily doses (DDD)/user/day: 39.1%, −0.02 DDD/user/day/year, 95% CI: −0.020 to −0.015, P < 0.001). In 2016, the highest mean doses were seen for clozapine (0.90–1.07 DDD/user/day) and olanzapine (0.66–0.88 DDD/user/day).ConclusionsThere is an increased prevalence of antipsychotic prescriptions that coincides with low and/or decreasing mean doses of the majority of commonly used antipsychotics in Scandinavia. Of all antipsychotics, this development was most pronounced for quetiapine. Reasons for and consequences of increased antipsychotic use that lasts shorter periods of time requires further study.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ueda2019,

title = {Glucagon-Like Peptide 1 Receptor Agonists and Risk of Diabetic Retinopathy Complications: Cohort Study in Nationwide Registers From Two Countries},

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

doi = {10.2337/dc18-2532},

issn = {1935-5548},

year  = {2019},

date = {2019-06-01},

volume = {42},

number = {6},

pages = {e92--e94},

publisher = {American Diabetes Association},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Wintzell2019,

title = {Association between use of azathioprine and risk of acute pancreatitis in children with inflammatory bowel disease: a Swedish–Danish nationwide cohort study},

author = {Viktor Wintzell and Henrik Svanström and Ola Olén and Mads Melbye and Jonas F Ludvigsson and Björn Pasternak},

doi = {10.1016/s2352-4642(18)30401-2},

issn = {2352-4642},

year  = {2019},

date = {2019-03-00},

journal = {The Lancet Child & Adolescent Health},

volume = {3},

number = {3},

pages = {158--165},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Kristensen2019,

title = {Nonaspirin Nonsteroidal Antiinflammatory Drug Use in the Nordic Countries from a Cardiovascular Risk Perspective, 2000–2016: A Drug Utilization Study},

author = {Kasper Bruun Kristensen and Øystein Karlstad and Jaana E. Martikainen and Anton Pottegård and Jonas W. Wastesson and Helga Zoega and Morten Schmidt},

doi = {10.1002/phar.2217},

issn = {1875-9114},

year  = {2019},

date = {2019-02-00},

journal = {Pharmacotherapy},

volume = {39},

number = {2},

pages = {150--160},

publisher = {Wiley},

abstract = {Study ObjectiveEvidence on the cardiotoxicity of nonaspirin nonsteroidal antiinflammatory drugs (NSAIDs), particularly diclofenac and the newer selective cyclooxygenase (COX)‐2 inhibitors, has accumulated over the last decade. Our objective was to examine whether the use of NSAIDs in the Nordic countries changed with the emerging evidence, regulatory statements, and clinical guidelines advocating caution for the use of specific NSAIDs.DesignDrug utilization study.Data SourcesNationwide wholesale statistics and prescription registries in Denmark, Finland, Iceland, Norway, and Sweden (2000–2016).Measurements and Main ResultsOur main outcome measures were yearly total sales, expressed as number of sold defined daily doses (DDDs)/1000 inhabitants/day, and yearly prevalence of prescription use, expressed as number of prescription users per 1000 inhabitants. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. Total sales of NSAIDs increased in all countries and were highest in Iceland, with 74.3 DDDs/1000 inhabitants/day sold in 2016, followed by Finland (73.9), Sweden (54.4), Norway (43.8), and Denmark (31.8). Diclofenac use declined after 2008 in all countries but remained the most widely prescribed NSAID in Norway, with 63 prescription users/1000 inhabitants in 2016. Diclofenac sales also remained high in Iceland (12.7 DDD/1000 inhabitants/day), Norway (8.1), and Sweden (7.8). Since its introduction in 2003, the use of etoricoxib, a newer selective COX‐2 inhibitor, increased in all countries except Denmark, with highest sales in Finland (6.7 DDD/1000 inhabitants/day in 2016).ConclusionSales and prescription patterns of NSAIDs in the Nordic countries has changed along with the accumulating evidence for the cardiovascular risks of specific NSAIDs. However, given existing evidence on the cardiovascular risks associated with the use of diclofenac and etoricoxib, the persistent high use of diclofenac in Iceland, Norway, and Sweden, the persistent over‐the‐counter availability of diclofenac in Norway and Sweden, and the increasing use of etoricoxib in most of the Nordic countries pose a cardiovascular health concern.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Svanström2019,

title = {Use of liraglutide and risk of major cardiovascular events: a register-based cohort study in Denmark and Sweden},

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

doi = {10.1016/s2213-8587(18)30320-6},

issn = {2213-8587},

year  = {2019},

date = {2019-02-00},

journal = {The Lancet Diabetes & Endocrinology},

volume = {7},

number = {2},

pages = {106--114},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bateman2018,

title = {β-Blocker Use in Pregnancy and the Risk for Congenital Malformations},

author = {Brian T. Bateman and Uffe Heide-Jørgensen and Kristjana Einarsdóttir and Anders Engeland and Kari Furu and Mika Gissler and Sonia Hernandez-Diaz and Helle Kieler and Anna-Maria Lahesmaa-Korpinen and Helen Mogun and Mette Nørgaard and Johan Reutfors and Randi Selmer and Krista F. Huybrechts and Helga Zoega},

doi = {10.7326/m18-0338},

issn = {0003-4819},

year  = {2018},

date = {2018-11-20},

journal = {Ann Intern Med},

volume = {169},

number = {10},

publisher = {American College of Physicians},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ueda2018,

title = {Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study},

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

doi = {10.1136/bmj.k4365},

issn = {1756-1833},

year  = {2018},

date = {2018-11-14},

journal = {BMJ},

publisher = {BMJ},

abstract = {Abstract

          

            Objective

            To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverse events of current concern.

          

          

            Design

            Register based cohort study.

          

          

            Setting

            Sweden and Denmark from July 2013 to December 2016.

          

          

            Participants

            A propensity score matched cohort of 17 213 new users of SGLT2 inhibitors (dapagliflozin, 61%; empagliflozin, 38%; canagliflozin, 1%) and 17 213 new users of the active comparator, glucagon-like peptide 1 (GLP1) receptor agonists.

          

          

            Main outcome measures

            The primary outcomes were lower limb amputation, bone fracture, diabetic ketoacidosis, acute kidney injury, serious urinary tract infection, venous thromboembolism, and acute pancreatitis, as identified from hospital records. Hazard ratios and 95% confidence intervals were estimated by using Cox proportional hazards models.

          

          

            Results

            

              Use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation (incidence rate 2.7

              v

              1.1 events per 1000 person years, hazard ratio 2.32, 95% confidence interval 1.37 to 3.91) and diabetic ketoacidosis (1.3

              v

              0.6, 2.14, 1.01 to 4.52) but not with bone fracture (15.4

              v

              13.9, 1.11, 0.93 to 1.33), acute kidney injury (2.3

              v

              3.2, 0.69, 0.45 to 1.05), serious urinary tract infection (5.4

              v

              6.0, 0.89, 0.67 to 1.19), venous thromboembolism (4.2

              v

              4.1, 0.99, 0.71 to 1.38) or acute pancreatitis (1.3

              v

              1.2, 1.16, 0.64 to 2.12).

            

          

          

            Conclusions

            In this analysis of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverse events of current concern.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Wastesson2018,

title = {Trends in Use of Paracetamol in the Nordic Countries},

author = {Jonas W. Wastesson and Jaana E. Martikainen and Helga Zoëga and Morten Schmidt and Øystein Karlstad and Anton Pottegård},

doi = {10.1111/bcpt.13003},

issn = {1742-7843},

year  = {2018},

date = {2018-09-00},

journal = {Basic Clin Pharma Tox},

volume = {123},

number = {3},

pages = {301--307},

publisher = {Wiley},

abstract = {AbstractParacetamol (acetaminophen) is one of the most commonly used analgesics in Europe; however, both the safety and efficacy of paracetamol have recently been questioned. Little is known about cross‐national differences in the sales of paracetamol. Using national wholesale statistics and nationwide prescription drug registers, we investigated trends in total and prescribed use of paracetamol in the Nordic countries. The total sales of paracetamol (Anatomical Therapeutic Chemical (ATC) classification system code: N02BE01) measured as defined daily doses (DDD) per 1000 inhabitants/day, and the sales by prescription (users per 1000 inhabitants/year), increased in the Nordic countries from 2000 to 2015. The total sales were highest in Denmark throughout the period, with 65 DDD per 1000 inhabitants/day and lowest in Iceland with 30 DDD per 1000 inhabitants/day in 2015. The cross‐national difference in total sales of paracetamol was smaller in 2015 than in 2000. The proportion of paracetamol (DDD per 1000 inhabitants/day) sold by prescription was also highest in Denmark (78%), compared with 75% in Finland, 69% in Sweden, 61% in Norway and 38% in Iceland. Paracetamol by prescription was more common at older ages and among women. Total and prescribed sales of paracetamol have increased in all five Nordic countries over time. Cross‐national differences exist, with highest sales per capita in Denmark throughout the period.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}