VASCEPA Significantly Reduced TG Levels Without Increasing LDL-C in Statin-Treated Patients As Compared To Placebo1

Median Percent Change in TG and LDL-C for VASCEPA 4 g/d Compared to Placebo1

ANCHOR Efficacy TG LDL
  • The effects of VASCEPA 4 g/d were assessed in a randomized, placebo-controlled, double-blind, parallel-group study evaluating statin-treated patients with residually high TG levels
  • 73% of patients had diabetes mellitus
  • The primary endpoint was the median percent change in TG levels from baseline to Week 12 as compared to placebo
  • In statin-treated patients, maintaining LDL-C control by the statin is an important goal when considering add-on therapy

 

 

Important Information for HCPs About VASCEPA as an Add-On to Statins in Patients with High
(200-499 mg/dL) TG Levels

  • Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. VASCEPA should not be taken in place of a healthy diet and lifestyle or statin therapy.
  • The ANCHOR trial demonstrates that VASCEPA lowers TG levels in patients with high (≥200 mg/dL and <500 mg/dL) TG levels not controlled by diet and statin therapy.
  • In the ANCHOR trial, VASCEPA 4 g/day significantly reduced TG, non-HDL-C, Apo B, VLDL-C, TC, and HDL-C levels from baseline relative to placebo in patients with high (≥200 mg/dL and <500 mg/dL) TG levels not controlled by diet and statin therapy.
  • The reduction in TG observed with VASCEPA was not associated with elevations in LDL-C relative to placebo.
  • VASCEPA is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (≥200 mg/dL and <500 mg/dL) TG levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin-lowered LDL-C on cardiovascular risk among statin-treated patients with residually high TG. No prospective study has been conducted to test and support what, if any, benefit exists.
  • Recent cardiovascular outcomes trials (ACCORD Lipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering TG levels in patients with high TG levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising HDL-C and reducing TG levels, among statin-treated patients with well-controlled LDL-C.
  • VASCEPA is not FDA-approved to reduce the risk of coronary heart disease.
  • The effect of VASCEPA on the risk of cardiovascular mortality and morbidity has not been determined.
  • A cardiovascular outcomes study of VASCEPA designed to evaluate the efficacy of VASCEPA in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy is currently underway (REDUCE-IT).
  • VASCEPA may not be eligible for reimbursement under government healthcare programs (such as Medicare and Medicaid) to reduce the risk of coronary heart disease or for treatment of statin-treated patients with mixed dyslipidemia and high (≥200 mg/dL and <500 mg/dL) TG levels. We encourage you to check for yourself.
  • The ANCHOR trial was sponsored by Amarin Pharma, Inc. and its affiliates.
Reference: 1. Ballantyne CM, Bays HE, Kastelein JJ, et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012;110(7):984-992.