Are plant sterols and stanols safe for a pregnant patient with hypercholesterolemia?

Plant Sterols and Stanols in Pregnancy

Plant sterols and stanols are safe for pregnant patients with hypercholesterolemia and should be used as part of intensive lifestyle interventions to manage elevated LDL cholesterol. 1

Primary Recommendation

• Plant stanols/sterols at 2 g/day can lower LDL cholesterol by up to 15% and are considered a therapeutic dietary option for pregnant women with elevated LDL cholesterol. 2
• These compounds work by inhibiting cholesterol absorption in the intestine and are virtually unabsorbable systemically, making them ideal for use during pregnancy. 3
• The American Heart Association explicitly recommends plant stanols/sterols as part of dietary therapy for lipid management, with no contraindication during pregnancy. 2

Evidence Supporting Safety in Pregnancy

• A randomized controlled trial specifically evaluated plant stanol ester spreads during pregnancy and lactation, demonstrating clinical safety with no adverse effects on length of gestation or infant growth. 4
• In this study, pregnant women consuming 1.1 g/day of plant stanols during pregnancy showed expected changes in maternal cholesterol metabolism markers without harm to mother or infant. 4
• Plant stanols are minimally absorbed (unlike plant sterols), which further supports their safety profile during pregnancy. 5

How to Implement

• Recommend 2 g/day of plant stanols/sterols through fortified foods such as margarine spreads, orange juice, or soft gel capsules. 2
• These products must be consumed daily to maintain LDL cholesterol reductions, similar to medication adherence. 2
• Plant stanols/sterols should be integrated into a comprehensive heart-healthy diet that limits saturated fat to <7% of total calories and cholesterol to <200 mg/day. 2

Important Caveat: Beta-Carotene Monitoring

• The one potential concern is that plant stanol consumption may lower serum beta-carotene concentrations in infants at 1 month of age. 4
• While this effect was observed in the intervention group, it did not impact overall infant health or growth through 1 year of age. 4
• To mitigate this risk, ensure pregnant women consuming plant stanols maintain adequate intake of deeply colored fruits and vegetables (spinach, carrots, peaches, berries) to preserve beta-carotene levels. 2

Integration with Other Pregnancy-Safe Treatments

• Plant stanols/sterols complement bile acid sequestrants (cholestyramine, colestipol, colesevelam), which are the only pharmacological agents considered safe during pregnancy. 1, 6
• For pregnant women with severe hypercholesterolemia requiring pharmacotherapy, bile acid sequestrants should be the first-line medication, with plant stanols/sterols as an adjunctive dietary measure. 1
• Unlike statins, ezetimibe, PCSK9 inhibitors, bempedoic acid, fibrates, and niacin—which must be avoided during pregnancy—plant stanols/sterols carry no such restrictions. 1, 6

Practical Clinical Approach

• Start with intensive lifestyle modification including plant stanols/sterols 2 g/day for all pregnant women with elevated LDL cholesterol. 1
• If LDL cholesterol remains significantly elevated despite dietary measures, add bile acid sequestrants under specialist guidance. 1
• For extremely high-risk patients (homozygous familial hypercholesterolemia with established ASCVD), lipoprotein apheresis should be considered during pregnancy. 1
• Monitor triglycerides closely, as severe hypertriglyceridemia (≥500 mg/dL) poses pancreatitis risk and requires dietary fat restriction. 6