Maternal Exposure to Statins Not Linked With Congenital Anomalies: JAMA

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.

Key findings of the study:

• The researchers enrolled 469 women who used statins during pregnancy and 4690 age-matched controls with no statin exposure during pregnancy.
• After controlling for maternal comorbidities and age, they found that low birth weight was more common among offspring in the statin-exposed group (RR, 1.51), with a greater chance of preterm birth (RR, 1.99) and a lower 1-minute Apgar score (RR, 1.83).
• They found that congenital anomalies were not associated with statin exposure during pregnancy.
• The multivariable analysis also showed no association between statin use for periconceptual hyperlipidemia and adverse perinatal outcomes among women who had used statins prior to pregnancy.

The authors concluded, "This study suggests that statins may be safe when used during pregnancy because there was no association with congenital anomalies, but caution is needed because of an increased risk of low birth weight and preterm labor. The data also suggest that statins could be safely used during pregnancy for women with long-term use of statins before pregnancy."

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DOI:10.1001/jamanetworkopen.2021.41321