Antidepressant use during pregnancy and risk of congenital heart defects: A case‐time‐control study

Sun, Yuelian; Pedersen, Lars Henning; Wu, Chun Sen; Petersen, Irene; Sørensen, Henrik Toft; Olsen, Jørn

doi:10.1002/pds.4844

Cited by 6 publications

(7 citation statements)

References 52 publications

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“…Of the 114 included articles, the case‐crossover design was the most common (100, 88%), 18–117 followed by the case‐time‐control (19, 17%), 38,63,67,71,86,118–131 and case‐case‐time‐control (4, 3%) 33,47,48,86 . (Table 1) The most common outcomes measured in these studies were hospitalization (43, 38%), cardiovascular events (22, 19%) and fall‐related injury/fracture (15, 13%).…”

Section: Resultsmentioning

confidence: 99%

Evaluating the use of methods to mitigate bias from non‐transient medications in the case‐crossover design: A systematic review

Huang

Tadrous

et al. 2023

Pharmacoepidemiology and Drug

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Purpose The case‐crossover design is a self‐controlled study design used to compare exposure immediately preceding an event occurrence with exposure in earlier control periods. The design is most suitable for transient exposures in order to avoid biases that can be problematic when using the case‐crossover design for non‐transient (i.e., chronic) exposures. Our goal was to conduct a systematic review of case‐crossover studies and its variants (case‐time‐control and case‐case‐time‐control) in order to compare design and analysis choices by medication type. Methods We conducted a systematic search to identify recent case‐crossover, case‐time‐control, and case‐case‐time‐control studies focused on medication exposures. Articles indexed in MEDLINE and EMBASE using these study designs that were published between January 2015 and December 2021 in the English language were identified. Reviews, methodological studies, commentaries, articles without medications as the exposure of interest, and articles with no available full text were excluded. Study characteristics including study design, outcome, risk window, control window, reporting of discordant pairs, and inclusion of sensitivity analyses were summarized overall and by medication type. We further evaluated the implementation of recommended methods to account for biases introduced by non‐transient exposures among articles that used the case‐crossover design on a non‐transient exposure. Results Of the 2036 articles initially identified, 114 articles were included. The case‐crossover was the most common study design (88%), followed by the case‐time‐control (17%), and case‐case‐time‐control (3%). Fifty‐three percent of the articles included only transient medications, 35% included only non‐transient medications, and 12% included both. Across years, the proportion of case‐crossover articles evaluating a non‐transient medication ranged from 30% in 2018 to 69% in 2017. We found that 41% of the articles that evaluated a non‐transient medication did not apply any of the recommended methods to account for biases and more than half of which were conducted by authors with no previous publication history of case‐crossover studies. Conclusion Using the case‐crossover design to evaluate a non‐transient medication remains common in pharmacoepidemiology. Researchers should apply appropriate design and analysis choices when opting to use a case‐crossover design with non‐transient medication exposures.

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Section: Resultsmentioning

confidence: 99%

Evaluating the use of methods to mitigate bias from non‐transient medications in the case‐crossover design: A systematic review

Huang

Tadrous

et al. 2023

Pharmacoepidemiology and Drug

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“…The case-time-control design, therefore, mitigates bias stemming from exposure time trends by including a control group. 18,20,21 In addition, it is worth noting that databases lacking precise last menstrual period data may hinder the ability to estimate the magnitude of the effect using the case-time-control design. 31,32 The negative control design in our study, which redefined different risk periods before the last menstrual period, yielded null results, and further strengthened the accuracy of the approach we used to determine the last menstrual period.…”

Section: Discussionmentioning

confidence: 99%

“…19 This design therefore adjusts for timeinvariant confounders and exposure time-trend bias resulting from changing of prescription patterns over the pregnancyrelated periods. [20][21][22] The case individuals in our case-crossover analysis were women with pregnancies resulting in miscarriage. We then used risk-set sampling to identify exposure time-trend controls from the pregnant women.…”

Section: Meaningmentioning

confidence: 99%

Benzodiazepine Use During Pregnancy and Risk of Miscarriage

Meng,

Lin,

Chuang

et al. 2024

JAMA Psychiatry

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ImportanceBenzodiazepine use during pregnancy has raised significant concerns due to the potential harmful effects of this drug class on neonates. Studies on the association between benzodiazepine use and the risk of miscarriage are limited.ObjectiveTo quantify the risk of miscarriage associated with benzodiazepine use during pregnancy after controlling for unmeasured confounders and exposure time trends.Design, Setting, and ParticipantsThis was a nationwide, population-based case-time-control study using Taiwan’s National Birth Certificate Application database and the National Health Insurance database. Pregnancies resulting in miscarriage between 2004 and 2018 were included in the case group and were 1:1 matched with exposure time-trend control individuals using disease risk score, considering demographic characteristics and prepregnancy comorbidities. Data were analyzed from August 2022 to March 2023.ExposuresDiscordant exposures to benzodiazepines during risk period (1-28 days before miscarriage) and 2 reference periods (31-58 days and 181-208 days before the last menstrual period) were compared for each pregnancy.Main Outcomes and MeasuresMiscarriage was defined as any pregnancy loss occurring between the first prenatal care visit (usually 8 weeks) and the 19th completed week of pregnancy.ResultsThis study comprised a total of 3 067 122 pregnancies among 1 957 601 women, 136 134 of which (4.4%) resulted in miscarriage. The mean (SD) age of the study population was 30.61 (5.91) years. The use of benzodiazepines during pregnancy was associated with an increased risk of miscarriage (odds ratio [OR], 1.69; 95% CI, 1.52-1.87), and consistent findings were observed across multiple sensitivity analyses considering different time windows and accounting for misclassification. In subgroup analyses, an increased risk of miscarriage was associated with each commonly used individual benzodiazepine, ranging from case-time-control ORs of 1.39 (95% CI, 1.17-1.66) for alprazolam to 2.52 (95% CI, 1.89-3.36) for fludiazepam.Conclusions and RelevanceThis nationwide case-time-control study revealed an increased risk of miscarriage associated with benzodiazepine use during pregnancy after accounting for measurable confounders, and results were unlikely to be due to unmeasured confounding. These findings underscore the necessity for health care professionals to meticulously balance the risk-benefit ratio when considering the use of benzodiazepines to treat psychiatric and sleep disorders during pregnancy.

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“…A case-control design has been used previously to examine the association of congenital heart defects with antidepressant use in pregnant mothers. 16 Still, to our knowledge, no studies have used a similar design to understand the risk of delirium posed by antimuscarinic drugs in older adults. Therefore, our study chose a case-time-control design to mitigate confounding from unknown time-invariant confounders.…”

Section: Introductionmentioning

confidence: 99%

“…To understand and quantify the risk of new‐onset delirium posed by antimuscarinics, we need reliable population‐level evidence with appropriate control for confounding. A case–control design has been used previously to examine the association of congenital heart defects with antidepressant use in pregnant mothers 16 . Still, to our knowledge, no studies have used a similar design to understand the risk of delirium posed by antimuscarinic drugs in older adults.…”

Section: Introductionmentioning

confidence: 99%

Risk of delirium associated with antimuscarinics in older adults: A case‐time‐control study

Nishtala

Chyou

2022

Pharmacoepidemiology and Drug

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Background: Older adults are at an increased risk of delirium because of age, polypharmacy, multiple comorbidities and acute illness. Antimuscarinics are the backbone of the pharmacological management of overactive bladder. However, the safety profiles of antimuscarinics vary because of their dissimilarities to muscarinic receptor-subtype affinities and are associated with differential central anticholinergic adverse effects.Objective: This study aimed to examine delirium risk in new users of oxybutynin and solifenacin in older adults (≥ 65 years). In the secondary analyses, we examined the risk of delirium by type and dose of antimuscarinic.Method: We applied a case-time-control design to investigate delirium risk in older adults who started taking oxybutynin and solifenacin. We used a nationwide inpatient hospital data (2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015)(2016), National Minimum Data Set, maintained by the Ministry of Health, New Zealand (NZ), to identify older adults with a new-onset diagnosis of delirium. Eligible patients were older adults aged 65 at entry into the cohort on 1/1/2006. We used dispensing claims data to determine antimuscarinic treatment exposure. The antimuscarinic included in the study were new users of oxybutynin and solifenacin. These two antimuscarinics are subsidised by the Pharmaceutical Management Agency and are the most frequently used antimuscarinic in NZ. A conditional logistic regression model was used to compute matched odds ratios (MORs) and 95% confidence intervals (CIs). In the case-time-control design, we made separate analyses to evaluate the dose-response risk of delirium.Results: We identified 4818 individuals (mean age 82.14) from 2005 to 2015 with incident delirium and were exposed to at least one of the antimuscarinic of interest. The casetime-control matched odds ratio (MOR) for delirium with oxybutynin was (2.06, 95% confidence interval [CI] 1.07-3.96). Solifenacin was not associated with delirium (0.89 95%CI 0.64-1.23). In the sensitivity analyses, the case-time-control MOR for delirium using a shorter risk period (0-3 days) did not change the results. The dose-response risk of delirium was significant for oxybutynin (0.05, 95%CI 0.02-0.08) but not for solifenacin (À0.01, 95%CI À0.03 to 0.00). In addition, in the subgroup analyses, a statistically significant association of delirium was found for oxybutynin but not for solifenacin in the non-dementia cohort (2.11,95% CI 1.08-4.13) and the dementia cohort (1.25, 95%CI 0.05-26.9).

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Antidepressant use during pregnancy and risk of congenital heart defects: A case‐time‐control study

Cited by 6 publications

References 52 publications

Evaluating the use of methods to mitigate bias from non‐transient medications in the case‐crossover design: A systematic review

Evaluating the use of methods to mitigate bias from non‐transient medications in the case‐crossover design: A systematic review

Benzodiazepine Use During Pregnancy and Risk of Miscarriage

Risk of delirium associated with antimuscarinics in older adults: A case‐time‐control study

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