Abstract
Introduction: Statins are used to treat those with hyperlipidemia and at high risk for a cardiovascular event, including women of childbearing potential. Traditionally, statins have been contraindicated during pregnancy because of a theoretical risk of teratogenicity. The FDA removed the black box warning for usage during pregnancy in 2021and recent observational studies have reported a relatively safe profile of statin use during pregnancy. However, ongoing evidence is needed because of the small samples and limited data available. Therefore, the objective of this study is to report perinatal outcomes of statin use during pregnancy. Methods: Patients taking a statin while pregnant were matched 1:10 to non-statin pregnant patients by age (±1 years), date of delivery (±2 years), hypertension, diabetes, and smoking history. All patients were > 18 years of age and received prenatal and delivery care between 1997 and 2021 at Intermountain Health, a system of 24 hospitals and 215 clinics in Utah, Idaho, and Nevada. Data for this study utilized electronic health records stored in Intermountain’s data warehouse. Results: A total of 57 statin-user pregnancies were well-matched to 570 non-statin user pregnancies (Table 1). No significant differences were found between the groups for miscarriage, pre-term delivery, preclampsia/eclampsia, and congenital anomalies (Table 2). Mean length of statin use prior to pregnancy was 1.3±2.5 years. Among those without miscarriages, 59.6% discontinued statin use, with a mean length of use while pregnant before discontinuation being 5 months. Conclusions: This study suggests that statin use while pregnant may be safe with no congenital anomalies being found. However, ongoing surveillance is needed because of the small sample size of statin users that can make it difficult to detect associations.
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