Statins in High-Risk Pregnancies: A Potential Role Despite Caution

For years, medical guidelines have advised against statin use during pregnancy, citing concerns over fetal safety. Both the European Society of Cardiology and the US Food and Drug Administration (FDA) recommend discontinuing statins for pregnant patients.

However, recent data suggest that for a small subset of very high-risk individuals—such as those with familial hypercholesterolemia or a history of cardiovascular events—statins may still play a critical role in cholesterol management.

Statin Use in High-Risk Pregnancies

·         Speaking at a cardio-obstetrics meeting hosted by the American College of Cardiology, Emily Schwabe, highlighted emerging evidence suggesting that statins might be safe and beneficial for select high-risk pregnant patients.

·         While concerns about teratogenic effects persist, a 2015 Medicaid cohort study involving 88,700 women showed no significant differences in congenital abnormalities between those exposed to statins and those who were not.

·         Similarly, a 2016 systematic review and a 2017 retrospective study found no significant increase in miscarriage risk associated with statin use.

·         Given these findings, clinicians may consider prescribing statins for very high-risk pregnant patients after thorough patient-clinician discussions regarding risks and benefits.

·         Schwabe advised that if statin therapy is necessary, delaying initiation until after the first trimester and switching to pravastatin, a hydrophilic statin with lower placental transfer, may be the best approach.

Pravastatin and Preeclampsia Prevention

Beyond cholesterol management, pravastatin has recently been studied as a potential therapy to prevent preeclampsia, a life-threatening hypertensive disorder in pregnancy. Research findings have been mixed:

• A 2021 multicenter, double-blind study published in Circulation found no significant difference in preeclampsia rates between women taking pravastatin and those on a placebo.

• However, the 2024 INOVASIA study (Indonesia Pravastatin to Prevent Preeclampsia Study), which included 80 high-risk pregnant patients, found that those on pravastatin experienced a lower rate of iatrogenic preterm delivery and their neonates had higher birth weights and lower NICU admission rates compared to controls.

While these findings are promising, Schwabe emphasized that larger, randomized controlled trials with long-term follow-up are needed to determine the efficacy and safety of statins in preeclampsia prevention.

Challenges in Cholesterol Management During Pregnancy

Managing cholesterol during pregnancy is critical, particularly for women with previous cardiac events or a high predisposition to cardiovascular disease. LDL cholesterol naturally rises during pregnancy and breastfeeding, making pre-conception lipid control an important aspect of maternal health.

Despite the FDA's 2021 removal of the black box warning on statins during pregnancy, many clinicians remain hesitant to prescribe them. Most cardio-obstetric specialists feel comfortable prescribing hydrophilic statins (e.g., pravastatin) in low to moderate doses, but patients often express concerns about taking medications during pregnancy. This requires careful patient-centered discussions that weigh medical necessity against individual concerns and beliefs.

For those seeking alternative cholesterol management options, cholestyramine can be used safely throughout pregnancy. However, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors should be discontinued before conception and resumed post-breastfeeding.

Looking Ahead: The Future of Statins in Pregnancy

Research into statin use during pregnancy remains limited by small sample sizes, study inconsistencies and heterogeneous patient populations. The emerging data suggest a possible role for statins in high-risk pregnancies, particularly for cardiovascular disease management and preeclampsia prevention.

However, further large-scale studies are required before statins become a mainstream recommendation for pregnant patients.

While society guidelines do not currently recommend statins for preeclampsia prevention, clinicians can follow American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) recommendations to initiate low-dose aspirin (81 mg/day) for at-risk patients.

As research progresses, the debate over statins in pregnancy will continue. For now, clinicians must navigate a delicate balance: ensuring optimal maternal cardiovascular health while prioritizing fetal safety.

By - Eeshan Aggarwal

Referencehttps://www.medscape.com/viewarticle/dont-discount-statins-very-high-risk-pregnancies-2025a10003hw