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Background <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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Pregnancy and neonatal outcomes following statin exposure in early pregnancy: a nationwide consultation-based cohort study in Japan

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月14日

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  • Izumi Fujioka,
  • Mikako Goto,
  • Tatsuhiko Anzai,
  • Kunihiko Takahashi,
  • Sachi Koinuma,
  • Atsuko Murashima

摘要

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.