Statin use during pregnancy: a systematic review and meta-analysis

Abstract

Statins enjoy widespread acceptance as effective drugs to reduce morbidity and mortality in patients with and without cardiovascular disease, and are considered safe for long-term use. However, these compounds are contraindicated during pregnancy based on their potential teratogenic effects. Owing to the increasing number of young women eligible for statin therapy and the concern that the discontinuation of statin therapy might be harmful for both mother and child with hypercholesterolemia, gestational exposure to statins has increasingly become an issue of significant clinical importance. In this systematic review of both human and animal studies on the teratogenic effects of statins during pregnancy, we found that most of the available data in fact suggests that statins are unlikely to be teratogenic. In humans, the observed congenital anomalies were isolated and no consistent pattern has emerged to suggest that a common mechanism could underlie these observations. Animal studies show conflicting results, but in the reports in which an excess of congenital anomalies was reported in the statin-treated rodents, excessive doses were used compared with the regimens we commonly prescribe to human subjects.

Keywords::

• congenital anomalies
• hypercholesterolemia
• pregnancy
• statins
• teratogenic effects

Acknowledgements

The authors thank Leon Bax for kindly translating the Japanese publications and Eva Pajkrt for the interpretation of the birth defects.

Financial & competing interests disclosure

JJP Kastelein has received grant support from AstraZeneca, Pfizer, Roche, Novartis, Merck, Merck Schering-Plough, Isis, Genzyme and sanofi-aventis; lecture fees from AstraZeneca, GlaxoSmithKline, Pfizer, Novartis, Merck–Schering-Plough, Roche, Isis and Boehringer Ingelheim; and consulting fees from AstraZeneca, Abbott, Pfizer, Isis, Genzyme, Roche, Novartis, Merck, Merck Schering-Plough and sanofi-aventis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.