Statin Discontinuation Before Pregnancy Not Tied to Adverse Maternal CV Outcomes: Study
South Korea: Researchers have found in a new study that Korean women who discontinued statin therapy before pregnancy did not experience an increased risk of maternal cardiovascular events. Notably, statin discontinuation was associated with a trend toward lower risks of non–live birth and low birth weight, suggesting no adverse and potentially favorable pregnancy outcomes.
The findings are from a large nationwide cohort study published in Circulation by Yongtai Cho, PharmD, from the School of Pharmacy, Sungkyunkwan University, Suwon, South Korea, and colleagues. The study addresses a long-standing clinical dilemma surrounding statin use in women of childbearing age, particularly those with high cardiovascular risk.
Statins are widely prescribed for dyslipidemia and cardiovascular disease prevention, but their use during pregnancy remains controversial. Although the US Food and Drug Administration removed the formal contraindication for statin use in pregnancy in 2021 to encourage individualized decision-making, major cardiovascular guidelines continue to advise discontinuation before conception. Evidence guiding these recommendations has largely focused on fetal outcomes, with limited data on maternal cardiovascular safety.
To bridge this gap, the researchers analyzed data from the National Health Insurance Database of South Korea collected between 2009 and 2023. The cohort included 13,374 women who had used statins for 12 to 24 weeks before their last menstrual period (LMP) between 2010 and 2022. Participants were categorized based on whether they discontinued statins before the LMP or continued therapy beyond it.
Maternal cardiovascular outcomes were assessed using major adverse cardiovascular and cerebrovascular events (MACCE), which included myocardial infarction, stroke, coronary revascularization, and cardiovascular death. Gestational and fetal outcomes evaluated in the study comprised preterm delivery, hypertensive disorders of pregnancy, gestational diabetes, nonlive birth, congenital malformations, and low birth weight.
The following were the key findings of the study:
- After adjustment for potential confounders using propensity score overlap weighting, no significant difference was observed in maternal cardiovascular risk between women who discontinued statins and those who continued therapy.
- The hazard ratio for major adverse cardiovascular and cerebrovascular events (MACCE) was 1.00, indicating that statin discontinuation was not associated with an increased maternal cardiovascular risk.
- Similar neutral cardiovascular risk findings were noted among women with pre-existing atherosclerotic cardiovascular disease or familial hypercholesterolemia.
- Statin discontinuation prior to pregnancy was associated with better fetal outcomes, including a significantly lower risk of nonlive birth.
- Women who stopped statin therapy also had a reduced risk of delivering infants with low birth weight compared with those who continued treatment.
- The observed differences in fetal outcomes were considered secondary findings and should be interpreted cautiously given the observational design of the study.
The investigators acknowledged several limitations, including the potential for residual confounding, reliance on claims data to infer medication use, and the lack of information on statin dosage and intensity. Despite extensive sensitivity analyses, causal relationships cannot be firmly established.
Overall, the study suggests that temporary discontinuation of statins before pregnancy may not compromise maternal cardiovascular health, even in high-risk women. The authors advocate for individualized, case-by-case decision-making when considering statin therapy in pregnancy, balancing maternal cardiovascular needs with fetal safety.
Reference:
Cho Y, Kang D, Lim H, Lee H, Choi EY, Shin JY, Choi KH. Association of Statin Discontinuation in Pregnancy With Maternal Cardiovascular Health and Birth Outcomes: A Nationwide Cohort Study. Circulation. 2026 Jan 23. doi: 10.1161/CIRCULATIONAHA.125.078919. Epub ahead of print. PMID: 41574427.
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