Peer-reviewed article
Pregnancy and neonatal outcomes following statin exposure in early pregnancy: a nationwide consultation-based cohort study in Japan.
Fujioka I, Goto M, Anzai T, Takahashi K, Koinuma S et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study examined whether statins taken during early pregnancy increase the risk of birth defects or other perinatal complications in Japan. Researchers compared 65 pregnant women who were exposed to statins with 903 unexposed women, using data from a national pregnancy database. The study found no significant increase in congenital anomalies at one month after birth, though results were imprecise due to the small exposed group size.
Key points
- No significant difference in congenital anomalies between statin-exposed (1.6%) and control (1.6%) groups after matching
- Estimates for congenital anomalies were imprecise with wide confidence intervals (0.06–15.99)
- Some analyses suggested increased risks of preterm birth (4.26 times higher) and low birth weight (3.32 times higher), but these findings were inconsistent across statistical methods
- Study included only 65 women exposed to statins during early pregnancy, limiting power to detect rare outcomes
- Authors note further research is needed to clarify perinatal risks of statin use in pregnancy
Limitations
This study is underpowered for detecting rare outcomes due to the small number of statin-exposed pregnancies (n=65), and results differed depending on the statistical method used (propensity score matching versus inverse probability weighting), making conclusions uncertain. The study measures congenital anomalies only at one month of age, which may not capture all birth defects.
Abstract
BACKGROUND: Statins are generally recommended to be discontinued once pregnancy is recognized; however, unintentional exposure during early pregnancy may occur in women receiving long-term lipid-lowering therapy, and clinical decision-making often requires careful consideration of potential risks and benefits. We aimed to evaluate the risk of congenital anomalies detected at 1 month and perinatal outcomes among infants born to women exposed to statins during early pregnancy (4–13 weeks of gestation) in Japan. METHODS: Using data from the Japan Drug Information Institute in Pregnancy database (2005–2017), we compared pregnant women exposed to statins during early pregnancy (statin-exposed group) and unexposed controls. Neonatal congenital anomalies at 1 month among live births were the primary outcome; secondary outcomes included pregnancy outcomes such as live birth, miscarriage, abortion, and stillbirth. Propensity score matching (1:1) was conducted to estimate the associations between statin exposure and pregnancy outcomes, and inverse probability weighting was performed using stabilized weights as a sensitivity analysis. RESULTS: Among 968 eligible pregnant women, 65 were in the statin-exposed group and 903 in the control group. After propensity score matching, the prevalence of congenital anomalies did not significantly differ between the statin-exposed (1.6%) and control (1.6%) groups, however, estimates were imprecise (odds ratio: 1.00; 95% confidence interval: 0.06–15.99). Increased risks of preterm birth (risk ratio: 4.26 [2.02–8.99]) and low birth weight (risk ratio: 3.32 [1.73–6.36]) were observed in the IPW analysis but not in the primary PSM analysis. CONCLUSIONS: No increase was observed in congenital anomalies detected at 1 month among live births following early statin exposure, although the estimates were imprecise and the study was underpowered for rare outcomes. Higher risks of preterm birth and low birth weight were observed in weighted analyses but not in the primary propensity score–matched analysis. Further research is needed to clarify perinatal risks associated with statin use in pregnancy. These findings may help inform individualized shared decision-making for women who require statin therapy during pregnancy.