Pregnancy Outcome After First-Trimester Exposure to Statins: Study Results Based on the Embryotox Cohort.

IF 2.6 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2026-10-01 DOI:10.1002/pds.70481

Evelin Beck, Andrea T Adelsberger, Katarina Dathe

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引用次数: 0

Abstract

Purpose: This observational cohort study aimed to assess the risk of adverse pregnancy and neonatal outcomes in pregnancies exposed to statins during the first trimester, given that the use of statins during pregnancy remains controversial. The primary study endpoints were the rates of spontaneous abortion and major birth defects.

Methods: In total, 188 pregnancies exposed to statins in the first trimester were compared with a cohort of 564 pregnancies without the study medication, which were recorded at the Embryotox Centre between January 2000 and June 2021. The effect of statin exposure on pregnancy outcome was estimated using Cox proportional hazards regression models. Log-binomial regression was used to evaluate the risk of major birth defects.

Results: Major birth defects were observed in 10 of 135 (7.4%) infants in the statin cohort and in 12 of 501 (2.4%) infants in the comparison cohort (RR 3.09, 95% CI 1.37-7.00). After adjustment for relevant baseline covariates and additional maternal disease factors, the difference substantially attenuated (RRadj 2.16; 95% CI 0.88-5.31). The cumulative incidence of spontaneous abortion was 26.8% in the statin-exposed versus 15.0% in the comparison cohort (HR 1.86, 95% CI 1.13-3.04; HRadj 1.66, 95% CI 0.99-2.78).

Conclusions: Current evidence suggests that statins are not major teratogens. The observed associations between statin exposure and birth defects, as well as unfavourable pregnancy outcomes, are presumably influenced by confounding factors such as underlying maternal disease. Our study results lend support to this assumption. However, they should be interpreted cautiously due to the limited cohort size.

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妊娠早期接触他汀类药物后的妊娠结局：基于Embryotox队列的研究结果。

目的：本观察性队列研究旨在评估妊娠早期暴露于他汀类药物的不良妊娠和新生儿结局的风险，考虑到他汀类药物在妊娠期间的使用仍然存在争议。主要研究终点是自然流产率和主要出生缺陷率。方法：将2000年1月至2021年6月期间在Embryotox中心记录的564例未使用他汀类药物的妊娠与188例妊娠早期暴露于他汀类药物的妊娠进行比较。使用Cox比例风险回归模型估计他汀类药物暴露对妊娠结局的影响。采用对数二项回归法评估出生缺陷风险。结果：135名他汀类药物组婴儿中有10名（7.4%）出现严重出生缺陷，501名对照组婴儿中有12名（2.4%）出现严重出生缺陷（RR 3.09, 95% CI 1.37-7.00）。在校正相关基线协变量和其他母体疾病因素后，差异显著减弱（RRadj 2.16; 95% CI 0.88-5.31）。他汀暴露组自然流产的累积发生率为26.8%，而对照组为15.0% （HR 1.86, 95% CI 1.13-3.04; HRadj 1.66, 95% CI 0.99-2.78）。结论：目前的证据表明他汀类药物不是主要的致畸物。观察到的他汀类药物暴露与出生缺陷以及不良妊娠结局之间的关联可能受到诸如潜在母体疾病等混杂因素的影响。我们的研究结果支持这一假设。然而，由于队列规模有限，应谨慎解读。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.