Abstract 11600: Characteristics and Outcomes of Statin Use During Pregnancy: A US Real-World Experience

Abstract

Introduction: Statins traditionally have been contraindicated during pregnancy because of a theoretical risk of teratogenicity. However, emerging evidence to suggest relative safety and potential harm in contraindicating statins in high cardiovascular (CV)-risk pregnancies have led the FDA in 2021 to remove the “Pregnancy Category X” label. This has placed a heavy burden on physician-patient (pt) shared decision making in that statins “should be discontinued in most pregnant patients or consider the ongoing therapeutic needs of the individual pt, particularly those at very high risk for CV events during pregnancy”. Methods: The objective of this study was to describe the current real-world characteristics of pts prescribed a statin during pregnancy and pregnancy outcomes in a large US healthcare system. Pregnant pts taking a statin were identified by a search of the electronic medical records (eMR) of Intermountain Healthcare, a system of 24 hospitals and 215 clinics in Utah, Idaho, and Nevada, between 1997 and 2021, and pregnancy outcomes determined electronically. Statin pts were matched 1:10 by age (+/- 1 y) with non-statin pts. Characteristics and outcomes were determined, and adjusted odds ratios (aOR) were calculated. Results: A total of 63 statin-user pregnancies were matched to 630 controls. Stain pts had more co-morbidities and higher baseline lipids (Table 1). Adverse pregnancy outcomes were more frequent in statin users (Table 2A). However, statin use did not contribute significantly to multivariable risk prediction of miscarriage or congenital anomalies although possibly it did to eclampsia/preeclampsia (Table 2B). Conclusions: In a current real-world US experience, pts prescribed statins during pregnancy had more comorbidities and more adverse outcomes, including fetal anomalies. However, after adjustment, statin use did not contribute to multivariable risk prediction of miscarriage or congenital anomalies.