Statins are safer during pregnancy than previously thought

Current guidelines for the management of dyslipidemias do not recommend statins in pregnant women and in those considering pregnancy (Class III). This contraindication is based primarily on data for the first statin drug developed, namely lovastatin. Lovastatin was designated category X (contraindicated) during pregnancy because of its possible association with congenital anomalies in animal studies. A case report of a baby born with multiple abnormalities after in utero exposure to lovastatin has also raised concerns. Owing to ethical concerns, no large randomized clinical trials of newer statins during pregnancy have been performed. Nevertheless, this problem is highly relevant, since women of reproductive age may well have indications for lipid-lowering therapy. Moreover, there is a hypothesis that statins may have potential obstetric indications, for instance for preeclampsia treatment or prevention. In this regard, observational data are of particular importance.

At the end of December 2021, a large Taiwanese cohort study was published online in JAMA Network Open. This retrospective cohort included 1 443 657 pregnant women 18 years of age or older with their first infant born during the period from January 1, 2004, to December 31, 2014. A total of 469 women (mean [SD] age, 32.6 [5.4] years) who used statins during pregnancy were compared with 4690 matched controls who had no statin exposure during pregnancy. The statin-unexposed cohort (n = 4690) was matched to the exposed cohort according to maternal age and year of delivery at a ratio of 1 to 10.

After controlling for maternal comorbidities and age, low birth weight was more common among offspring in the statin-exposed group (RR, 1.51 [95% CI, 1.05-2.16]), with a greater chance of preterm birth (RR, 1.99 [95% CI, 1.46-2.71]), and a lower 1-minute Apgar score (RR, 1.83 [95% CI, 1.04-3.20]). Congenital anomalies were not associated with statin exposure during pregnancy. In addition, a separate multivariable analysis in women who used statins for more than 3 months prior to pregnancy, maintaining statin use during pregnancy did not increase the risk of ane adverse neonatal outcomes as compared to stopping them after conception.


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