Statins are the class of drug most commonly used to treat hyperlipidemia and have been used during pregnancy to prevent or treat preeclampsia (PE)
1,2 owing to their ability to reverse an angiogenic imbalance and correct endothelial dysfunction.
3 Other benefits associated with statins are control of gestational dyslipidemia from accelerated atherosclerotic disease in the child,
4 prevention of umbilical vein endothelial dysfunction,
5 and spontaneous preterm birth (PTB).
6 However, the safety of statins with regard to the fetus is of concern. The first statin drug developed, lovastatin, was designated category X (contraindicated) during pregnancy because of its possible association with congenital anomalies. The designation was based on animal studies showing developmental toxic effects and the recognition that cholesterol biosynthesis is critical to prenatal development.
7 In the 1980s and 1990s, animal studies of statins demonstrated skeletal malformations, gastroschisis, and a low birth weight (LBW) in rats and rabbits.
8,9 A case report of a baby born with VACTERL (vertebral, anal, cardiac, tracheal, esophageal, renal, and limb abnormalities) after in utero exposure to lovastatin has also raised concerns.
10 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. In most of the prior studies, the study population was small, and confounders (such as maternal comorbidities) were not fully documented.