What is the use of Vascepa (icosapent ethyl)?

Use of Vascepa (Icosapent Ethyl)

Vascepa (icosapent ethyl) is primarily indicated to reduce cardiovascular risk in patients with elevated triglycerides (135-499 mg/dL) who are on statin therapy with controlled LDL cholesterol and have either established atherosclerotic cardiovascular disease (ASCVD) or diabetes with additional cardiovascular risk factors.

Primary Indications

Vascepa has two main FDA-approved indications:

1. Cardiovascular Risk Reduction:

   • For patients with established ASCVD or diabetes plus at least two additional cardiovascular risk factors
   • Patient must be on statin therapy with controlled LDL-C (41-100 mg/dL)
   • Triglyceride levels should be 135-499 mg/dL
   • Recommended dose: 4g/day (2g twice daily with food) 1

2. Severe Hypertriglyceridemia:

   • For patients with severe hypertriglyceridemia (≥500 mg/dL)
   • Used as an adjunct to diet to reduce triglyceride levels
   • Recommended dose: 4g/day 2

Evidence Supporting Cardiovascular Risk Reduction

The REDUCE-IT trial provides the strongest evidence for Vascepa's cardiovascular benefits:

• 25% relative risk reduction in major adverse cardiovascular events
• 26% reduction in the composite of cardiovascular death, nonfatal MI, or nonfatal stroke
• 20% reduction in cardiovascular death
• Enrolled patients with established ASCVD (70%) or diabetes with additional risk factors (30%) 1

Clinical Considerations

Patient Selection

• Best candidates are those with:
  • Established ASCVD or diabetes with ≥2 additional risk factors
  • Controlled LDL-C on statin therapy
  • Triglycerides between 135-499 mg/dL
  • HbA1c <10%
  • No history of pancreatitis, atrial fibrillation, or severe heart failure 1

Administration

• Dosage: 4g daily (2g twice daily with food)
• Vascepa contains ≥96% EPA ethyl ester and does not contain DHA 2
• Unlike other omega-3 products containing both EPA and DHA, Vascepa does not increase LDL-C levels 3

Monitoring

• Monitor triglyceride levels
• Watch for potential side effects, particularly atrial fibrillation (5.3% vs 3.9% in placebo) 1

Important Distinctions

• Vascepa (icosapent ethyl) should not be confused with other omega-3 fatty acid products:
  • It contains only purified EPA, not DHA
  • Products containing both EPA and DHA have not shown the same cardiovascular benefits 1
  • The STRENGTH trial with a carboxylic acid formulation of EPA+DHA did not show cardiovascular benefit 1

Potential Mechanisms of Action

Vascepa's benefits may extend beyond triglyceride lowering:

• Reduces inflammatory markers (hsCRP reduced by 17.9%)
• Reduces oxidized LDL (13.7% reduction)
• Reduces lipoprotein-associated phospholipase A2 (19.6% reduction) 4

Common Pitfalls

1. Confusing with other omega-3 products: Vascepa is a prescription-only, highly purified EPA ethyl ester, not a dietary fish oil supplement.

2. Inappropriate patient selection: Vascepa's cardiovascular benefits are specifically demonstrated in patients with controlled LDL-C on statins but with residual elevated triglycerides.

3. Inadequate dosing: The full 4g daily dose (2g twice daily with food) is required for cardiovascular risk reduction.

4. Not monitoring for atrial fibrillation: There was a small but significant increase in atrial fibrillation risk in the REDUCE-IT trial.

Vascepa represents an important adjunctive therapy for reducing residual cardiovascular risk in appropriately selected patients already receiving standard-of-care statin therapy.