Key result
Continuation or reintroduction of statin therapy after the first trimester in high-risk women with familial hypercholesterolemia appears safe without increased risk of congenital malformations (adjusted OR 1.03, 95% CI 0.89–1.18) and may reduce prolonged off-treatment LDL-C exposure associated with increased ASCVD risk.
Why the study?
Practice and guidance for women with familial hypercholesterolaemia during the reproductive period are fragmented, leading to prolonged treatment interruptions and increased cumulative LDL-C exposure.
Effect estimate: Meta-analysis: adjusted OR 1.03 (95% CI 0.89–1.18) for congenital malformations with statin exposure in early pregnancy; Subgroup analysis OR 1.47 (95% CI 1.12–1.93) for congenital malformations with high-intensity statins (95% CI 0.89-1.18 for main result; 1.12-1.93 for high intensity subgroup)
This review provides practical guidance for managing lipid-lowering therapy in women with familial hypercholesterolemia during pregnancy and family planning to minimize prolonged off-statin periods and cumulative LDL-C exposure.
Women with familial hypercholesterolaemia (FH) accrue a high lifetime LDL-cholesterol (LDL-C) burden and face excess atherosclerotic cardiovascular disease risk that is amplified by prolonged off-statin periods related to family planning, pregnancy and breastfeeding. Current practice and guidance are fragmented, and many women experience long-treatment interruptions that increase the cumulative LDL-C exposure. This review provides a contemporary account of the extant evidence and offers practical, evidence-informed recommendations that focus primarily on women with FH; we address contraception, preconception assessment, management during pregnancy, breastfeeding duration, and timely postpartum reintroduction of lipid-lowering therapy (LLT). We emphasize individualized shared decision-making and multidisciplinary care involving lipidologists, obstetricians, genetic counsellors and other specialists; we also consider alternative options to reduce the risk of prolonged off-treatment periods. Recent regulatory and guideline changes that allow more flexible consideration of statin use in pregnancy for selected high-risk women highlight the need for clear guidance to minimize the cumulative LDL-C exposure, while respecting maternal-fetal safety. Priority actions include development of explicit family-planning and pregnancy guidance for women with FH and implementation strategies to embed these practices into routine care.
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Holven et al. (2026) conducted a review in Women with heterozygous familial hypercholesterolemia (HeFH) during reproductive period including pregnancy and breastfeeding. Statin therapy including continuation or reintroduction after first trimester during pregnancy in selected high-risk women with FH vs. Discontinuation of statin therapy during pregnancy was evaluated on Risk of congenital malformations and ASCVD risk related to statin exposure during pregnancy and cumulative LDL-cholesterol burden in women with FH (Meta-analysis: adjusted OR 1.03 (95% CI 0.89–1.18) for congenital malformations with statin exposure in early pregnancy; Subgroup analysis OR 1.47 (95% CI 1.12–1.93) for congenital malformations with high-intensity statins, 95% CI 0.89-1.18 for main result; 1.12-1.93 for high intensity subgroup). Continuation or reintroduction of statin therapy after the first trimester in high-risk women with familial hypercholesterolemia appears safe without increased risk of congenital malformations (adjusted OR 1.03, 95% CI 0.89–1.18) and may reduce prolonged off-treatment LDL-C exposure associated with increased ASCVD risk.
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