Ongoing Study of VASCEPA in Statin-Treated Patients

A cardiovascular outcomes study of VASCEPA designed to evaluate the efficacy of 4 g/d of VASCEPA in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy is currently underway (REDUCE-IT).

The effect of VASCEPA on cardiovascular mortality and morbidity has not been determined. Participants in the clinical investigation of VASCEPA currently underway (REDUCE-IT) should not be advised to use VASCEPA in place of participation in that study. VASCEPA should not be taken in place of a healthy diet and lifestyle or statin therapy.

For additional information about the
REDUCE-IT Study Design, click here.

REDUCE-IT program overview
  • Randomized, double-blind, parallel-group design
  • Secondary outcome measures: incidence of additional CV events, lipid and lipoprotein levels, subgroup analyses such as patients with diabetes, etc
  • International trial, first patient dosed: December 2011

Amarin may now disclose truthful, non-misleading information not included in the VASCEPA Prescribing Information to healthcare professionals pursuant to a federal court order issued on March 8, 2016 in Amarin Pharma Inc. v. United States Food and Drug Administration, 119 F. Supp. 3d. 196 (S.D.N.Y. 2015).

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 that for yourself.
  • The ANCHOR trial was sponsored by Amarin Pharma, Inc. and its affiliates.
References: 1. A study of AMR101 to evaluate its ability to reduce cardiovascular events in high risk patients with hypertriglyceridemia and on statin, the primary objective is to evaluate the effect of 4 g/day AMR101 for preventing the occurrence of a first major cardiovascular event, (REDUCE-IT). ClinicalTrials.gov website. http://www.clinicaltrials.gov/ct2/show/NCT01492361. Updated March 4, 2016. Accessed July 18, 2016. 2. Research and development. Amarin Pharma, Inc. website. http://www.amarincorp.com/products.html. Updated June 27, 2016. Accessed July 18, 2016.