Teratogenic Risk of Statins in Pregnancy
Teratogenic Risk of Statins in Pregnancy
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DOI：
10.1345/aph.1r202
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发表时间：
2012-10-01
影响因子：
2.9
通讯作者：
Cleveland, Kevin W.
中科院分区：
文献类型：
--
作者：
Godfrey, Laura M.;Erramouspe, John;Cleveland, Kevin W.
目的：为了评估他汀类药物在育龄妇女中的致畸潜力，数据来源：PubMed检索（1980- 2012年9月），使用检索词他汀类药物和妊娠，然后重复使用他汀类药物和致畸性。结果仅限于英文发表的文章使用他汀类药物在human.Study选择和数据提取：所有文章介绍的数据后，他汀类药物使用在任何妊娠三个月的妊娠结局被包括在内。三个病例报告，2个病例系列，2个系统评价，2个注册为基础的研究，和1个前瞻性的观察性队列studywere reviewed.DATA SYNTHESIS：由于最初的上市前研究洛伐他汀在动物中，致畸作用已被假定为是一个类的功能，他汀类药物的作用机制。已收集了妊娠期间人类暴露的数据，并以各种研究形式进行了分析，以制定关于他汀类药物实际致畸风险和相关出生缺陷模式的可用结论。虽然目前的趋势是实际风险低于曾经认为的，但现有文献受到潜在报告偏倚的限制，数据中存在重叠，并且经常缺乏妊娠期间报告畸形的他汀类药物总暴露量。此外，没有人体研究包括数据的2个最新的他汀类药物（瑞舒伐他汀，匹伐他汀）;更多的亲脂性他汀类药物（洛伐他汀，辛伐他汀）有最多的经验，从而有更多的证据相关的致畸potential.CONCLUSIONS：人类致畸风险尚未得到证实，也没有被排除在怀孕期间使用他汀类药物的现有数据。个体他汀类药物之间可能存在的风险差异需要进一步评估。其他数据，包括妊娠早期母亲意外暴露于他汀类药物的前瞻性观察队列，应进一步有助于阐明在该人群中使用他汀类药物的适当建议。
OBJECTIVE: To evaluate the teratogenic potential of statins in women of childbearing age.DATA SOURCES: A PubMed search (1980-September 2012) was performed using the search terms statin and pregnancy, then repeated using statin and teratogenicity. Results were limited to articles published in English reporting on use of statins in humans.STUDY SELECTION AND DATA EXTRACTION: All articles presenting data on pregnancy outcomes after statin use during any trimester of pregnancy were included. Three case reports, 2 case series, 2 systematic reviews, 2 registry-based studies, and 1 prospective observational cohort study were reviewed.DATA SYNTHESIS: Since initial premarketing studies of lovastatin in animals, teratogenesis has been assumed to be a classwide function of statins' mechanism of action. Data from human exposure during pregnancy have been gathered and analyzed in a variety of study formats to formulate useable conclusions on statins' actual teratogenic risk and pattern of associated birth defects. Although the current trend is that actual risk is lower than once thought, the available literature is limited by potential reporting bias, contains overlap in the data, and frequently lacks numbers of total exposures to statins during pregnancy with reported malformations. Additionally, no human studies included data on the 2 newest statins (rosuvastatin, pitavastatin); the more lipophilic statins (Iovastatin, simvastatin) have the most experience and thus have more evidence related to teratogenic potential.CONCLUSIONS: Human teratogenic risk has not been proven nor has it been ruled out by the available data on statin use in pregnancy. Possible differences in risk between individual statins require further evaluation. Additional data, including prospective observational cohorts with inadvertent maternal exposure to statins during early weeks of gestation, should further help to clarify appropriate recommendations for statin use in this population.