Maternal Exposure to Statins Not Linked With Congenital Anomalies: JAMA
Statins are the class of drug most commonly used to treat hyperlipidemia and have been used during pregnancy to prevent or treat preeclampsia (PE).
In a recent study, researchers found no association between statin use for periconceptual hyperlipidemia and adverse perinatal outcomes. The study findings were published in the JAMA Network Open on December 30, 2021.
The first statin drug, lovastatin, was designated category X (contraindicated) during pregnancy because of its possible association with congenital anomalies. Owing to ethical concerns, no large randomized clinical trial (RCT) of statin use during pregnancy has been performed, and only a few human cohort studies, case series, and 1 small RCT have focused on the use of statins during pregnancy. Therefore, researchers of the Taichung Veterans General Hospital, Taichung, Taiwan, conducted a study to examine the perinatal outcomes among offspring associated with maternal use of statins during pregnancy.
Owing to ethical issues, large RCTs are difficult to perform; hence, the researchers performed a retrospective nationwide cohort study reflecting real-world data with a large cohort. They included 1 443 657 pregnant women with their first infant born during the period from January 1, 2004, to December 31, 2014. They used data from the Taiwan National Health Insurance Research Database. They compared the data on congenital anomalies, birth weight, gestational age, preterm birth, low birth weight, very low birth weight, fetal distress, and Apgar score between participants with and participants without statin exposure during pregnancy. They used multivariable analyses to calculate the risk ratio and Poisson regression models to adjust for potential confounders. The researchers further performed a subgroup analysis to compare offspring of women who used statins for more than 3 months before pregnancy and maintained or stopped statin use after pregnancy.
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