RESULTS FROM THE ANCHOR STUDY1,2

Co-Administration Therapy With Statins For Additional Lipid Management in Mixed Dyslipidemia*

  • The effects of VASCEPA as add-on therapy to treatment with statins were evaluated in a randomized, placebo-controlled, double-blind, parallel-group study of 453 adult patients (226 receiving VASCEPA and 227 receiving placebo) with persistent high triglyceride levels (≥200 mg/dL and <500 mg/dL) despite statin therapy
  • All patients were receiving statin therapy (atorvastatin, rosuvastatin, or simvastatin) and were treated to low-density lipoprotein cholesterol (LDL-C) goal prior to randomization
  • Patients were randomized to either VASCEPA or placebo and treated for 12 weeks with statin co-therapy
  • The same statin at the same dose was continued throughout the study
  • The median baseline TG and LDL-C levels in these patients were 259 mg/dL and 83 mg/dL, respectively
  • The randomized population in this study was mostly white (96%) and male (61%)
  • The mean age was 61 years and the mean body mass index was 33 kg/m2
  • Seventy-three percent (73%) of patients had diabetes at baseline

Response to the Addition of VASCEPA to Ongoing Statin Therapy in Patients with High Triglyceride Levels
(≥200 mg/dL AND <500 mg/dL)

The changes in the major lipoprotein lipid parameters for the groups receiving VASCEPA plus statin or placebo plus statin are shown in the table.

(Data reviewed and confirmed by the FDA—indication not approved by the FDA)

Exhibit B ANCHOR

% change=median percent change from baseline.
Difference=median of (VASCEPA % change-placebo % change) (Hodges-Lehmann Estimate).
P values from Wilcoxon rank sum test.

 

*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 for yourself.
  • The ANCHOR trial was sponsored by Amarin Pharma, Inc. and its affiliates.
References: 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. 2. Amarin Pharma, Inc. v. United States Food and Drug Administration, 119 F. Supp. 3d. 196 (S.D.N.Y. 2015).