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.