Icosapent ethyl (Eicosapentaenoic acid ethyl ester): Effects upon high-sensitivity C-Reactive protein and lipid parameters in patients with metabolic syndrome

Abstract

Background: The aim of this analysis was to examine the effects of icosapent ethyl (eicosapentaenoic acid ethyl ester, IPE) on high-sensitivity C-reactive protein (hsCRP) and lipid parameters in patients with metabolic syndrome, with and without stable statin therapy. Methods: This post hoc exploratory analysis evaluated patients with metabolic syndrome treated with IPE 4 grams/day, IPE 2 grams/day, or placebo in phase 3, randomized, placebo-controlled studies entitled: MARINE [triglyceride (TG) levels ≥ 500 and ≤ 2000mg/dL] and ANCHOR [TG levels ≥ 200 and < 500mg/dL, despite low-density lipoprotein cholesterol (LDL-C) control with stable statin therapy]. Results: Compared with placebo in patients with metabolic syndrome in MARINE (n = 204) and ANCHOR (n = 645), at the approved dose of 4 grams/day, IPE significantly lowered hsCRP levels 40.0% (P = 0.0007) in MARINE and 23.0% (P = 0.0003) in ANCHOR. Compared with placebo in MARINE, which included patients with and without statin therapy, IPE 4 grams/day significantly reduced hsCRP levels 78.0% in statin-treated patients (P = 0.0035, n = 16). Compared with placebo in MARINE, IPE 4 grams/day significantly reduced TG levels (35.0%; P < 0.0001), non-high-density lipoprotein cholesterol (non-HDL-C; 19.9%; P < 0.0001), and apolipoprotein B levels (ApoB) (9.1%; P = 0.0015) without raising LDL-C levels. Compared with placebo in ANCHOR, IPE 4 grams/day significantly reduced TG (21.7%; P < 0.0001), non-HDL-C (13.5%; P < 0.0001), ApoB (8.8%; P < 0.0001), LDL-C (5.2%; P = 0.0236), and HDL-C levels (4.0%; P = 0.0053). Conclusions: Compared with placebo, IPE 4 grams/day significantly lowered hsCRP levels and improved lipids without raising LDL-C levels in patients with metabolic syndrome and high ( ≥ 200 and < 500 mg/dL) or very high ( ≥ 500 and ≤ 2000 mg/dL) TG levels, with or without stable statin therapy.