Abstract 15071: AMR101 Lowers Triglycerides, Atherogenic Lipoprotein, Phospholipase A2, and High-sensitivity C-reactive Protein Levels in Patients With High Triglycerides and on Background Statin Therapy (the ANCHOR Study)
Objective: AMR101 is an omega-3 agent containing ≥96% pure icosapent ethyl (ethyl-eicosapentaenoic acid [EPA], the ethyl ester of EPA). The efficacy and safety of AMR101 were evaluated in a phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week clinical trial (“ANCHOR”) in high-risk patients with residually high triglyceride (TG) levels despite LDL-C control (40-100 mg/dL) on optimized statin therapy. In previous studies, EPA + docosahexaenoic acid (DHA) in this population did not significantly reduce LDL-C or high-sensitivity C-reactive protein (hsCRP).
Methods: 702 patients with fasting TG 200-500 mg/dL on stable diet were randomized to placebo or AMR101 2 or 4 g/day. The primary end point was median % change in TG from baseline vs placebo at 12 weeks.
Results: Beyond the lipid effects achieved by stable statin therapy, AMR101 4 g/day further reduced placebo-adjusted TG levels from baseline by 21.5% (n=226, P<0.0001); AMR101 2 g/day reduced TG by 10.1% (n=234, P=0.0051) (baseline: 265 and 254 mg/dL). AMR101 produced greater TG reductions in patients with higher baseline TG and treated with higher statin efficacy regimens. AMR101 reduced TG similarly in those with or without diabetes mellitus. AMR101 4 g/day decreased placebo-adjusted LDL-C by 6.2% (P=0.0067 vs placebo); AMR101 2 g/day reduced LDL-C by 3.6% (P=0.0867, noninferior to placebo, prespecified +6% margin). AMR101 4 g/day significantly reduced placebo-adjusted non-HDL-C (-13.6%), apolipoprotein B (apoB; -9.3%), lipoprotein-associated phospholipase A2 (Lp-PLA2; -19.0%), VLDL-C (-24.4%), hsCRP (-0.5 mg/L; baseline: 2.2 mg/L), and total cholesterol (-12.0%). Except for hsCRP, AMR101 2 g/day also significantly reduced these parameters. Both AMR101 doses were well tolerated, with safety profiles similar to placebo.
Conclusions: In the largest omega-3 trial conducted in patients with high TG on statin therapy, AMR101 (at 4 g and 2 g/day) significantly reduced median placebo-corrected TG levels, as well as LDL-C and hsCRP (at 4 g/day). While other trials in hypertriglyceridemic patients on statin therapy suggest EPA and DHA combinations may reduce non-HDL-C, Lp-PLA2, and sometimes apoB, AMR101 not only reduced these parameters, but uniquely reduced LDL-C and hsCRP.
- © 2011 by American Heart Association, Inc.