Are Zetia (ezetimibe) and Vascepa (icosapent ethyl) safe and effective for lowering low-density lipoprotein (LDL) and total cholesterol in childbearing-age women?

Efficacy and Safety of Zetia and Vascepa in Women of Childbearing Age

Ezetimibe (Zetia) and icosapent ethyl (Vascepa) should be discontinued before planned conception and during pregnancy, with ezetimibe ideally stopped 1-3 months before attempting pregnancy and immediately if pregnancy is discovered. 1

Ezetimibe (Zetia)

Efficacy for Cholesterol Lowering

• As monotherapy: Reduces LDL cholesterol by 15-20% 2
• When combined with statins: Provides an additional 10-16% reduction in LDL cholesterol beyond statin therapy alone 3
• Effectively lowers total cholesterol and may have modest effects on raising HDL cholesterol (2.5-5%) 4

Safety in Women of Childbearing Age

• Must be discontinued before pregnancy

  • Should be stopped 1-3 months before planned conception 3, 1
  • If pregnancy occurs while taking ezetimibe, it should be discontinued immediately 3
  • Should not be used during breastfeeding 1

• The American College of Cardiology guidelines clearly state that ezetimibe should only be used during pregnancy if the potential benefit justifies the risk to the fetus 1

• For women with familial hypercholesterolemia (FH), pre-pregnancy counseling should be offered before starting ezetimibe therapy 3

Vascepa (Icosapent Ethyl)

Efficacy for Cholesterol Lowering

• Primary effect is on triglyceride reduction rather than direct LDL cholesterol lowering 5
• Approved for patients with triglyceride levels of 150-499 mg/dL 5
• Unlike some other omega-3 fatty acids, does not increase LDL cholesterol 5

Safety in Women of Childbearing Age

• Like other lipid-lowering medications, should be discontinued before planned pregnancy 1
• Clinical guidelines recommend avoiding all lipid-lowering drugs during pregnancy and nursing 1

Alternative Management During Pregnancy

For women requiring lipid management during pregnancy:

1. Bile acid sequestrants are the preferred pharmacological option during pregnancy 1

   • Require monitoring for vitamin K deficiency
   • Can provide moderate LDL-C reduction

2. Lifestyle interventions should be emphasized 1

   • Heart-healthy diet
   • Appropriate physical activity
   • Weight management

Special Considerations

High-Risk Patients

• Women with homozygous familial hypercholesterolemia (HoFH) or established atherosclerotic cardiovascular disease (ASCVD) may require special consideration 3, 1
• In these cases:
  • Consultation with a lipid specialist is strongly recommended 1
  • Lipoprotein apheresis may be considered during pregnancy 3
  • In rare cases of HoFH with ASCVD, continued use of lipid-lowering therapy may be considered after the first trimester if benefits outweigh risks 3

Contraception Requirements

• Women taking lipid-lowering medications must use reliable contraception 3
• Unplanned pregnancy while on these medications should be avoided 3

Resumption of Therapy

• Lipid-lowering medications may be resumed after completion of breastfeeding 1
• Regular monitoring of lipid levels should be conducted during this transition

Key Pitfalls to Avoid

1. Failing to counsel women about pregnancy risks before starting therapy
2. Not providing adequate contraception counseling
3. Continuing lipid-lowering medications during pregnancy without specialist consultation
4. Overlooking alternative management strategies during pregnancy
5. Neglecting to monitor for significant lipid elevations during pregnancy after medication discontinuation

In summary, while ezetimibe and icosapent ethyl are effective for their respective lipid targets, they should be avoided during pregnancy and in women planning pregnancy unless the potential cardiovascular benefit clearly outweighs the potential risks to the fetus, and this decision should be made in consultation with specialists.