Abstract 17499: ETC-1002 Incrementally Lowers Low Density Lipoprotein-cholesterol in Patients With Hypercholesterolemia Receiving Stable Statin Therapy
Background: ETC-1002 is an oral investigational drug that modulates hepatic adenosine triphosphate-citrate lyase to reduce cholesterol biosynthesis and may be beneficial in treating patients with elevated LDL-C despite using stable statin therapy. Methods: A double-blind, parallel group, placebo-controlled multicenter trial evaluated patients (n=134) with baseline LDL-C of 115-220 mg/dL while taking atorvastatin ≤20 mg, simvastatin ≤20 mg, rosuvastatin ≤10mg or pravastatin ≤40 mg randomized to ETC-1002 120 mg, ETC-1002 180 mg, or placebo once daily for 12 weeks. Results: ETC-1002 120 mg (p=0.0055) and 180 mg (p<0.0001) lowered LDL-C significantly more than placebo (primary endpoint) as an add-on to statin therapy. ETC-1002 also lowered (p<0.05) apolipoprotein B, non-high density lipoprotein-cholesterol, total cholesterol and LDL particle number more than placebo. C-reactive protein was also reduced with ETC-1002 120 mg (22%, p=0.26) and 180 mg (30%, p=0.08) versus 0% with placebo. Adverse events (AEs), muscle-related AEs, discontinuations due to AEs and levels of clinical safety labs were generally similar compared with placebo.
Conclusion: In patients with elevated LDL-C despite stable statin therapy, ETC-1002 produces incremental LDL-C lowering and is well-tolerated.
Author Disclosures: C.M. Ballantyne: Research Grant; Significant; Abbott Diagnostic, Amarin, Amgen, Eli Lilly, Esperion Therapeutics, Inc., Novartis, Pfizer, Otsuka, Regeneron, Roche Diagnostic, Sanofi-Synthelabo, Takeda, NIH, AHA, ADA. Consultant/Advisory Board; Modest; Abbott Diagnostic, Amarin, Eli Lilly, Esperion Therapeutics, Inc, Genzyme, Matinas BioPharma Inc, Novartis, Regeneron, Roche, Sanofi-Synthelabo. Consultant/Advisory Board; Significant; Amgen, AstraZeneca, Merck, Pfizer. D.E. MacDougall: Employment; Significant; Esperion Therapeutics, Inc. J.R. Margulies: Employment; Significant; Esperion Therapeutics, Inc. P.L. Robinson: Employment; Significant; Esperion Therapeutics, Inc. J.C. Hanselman: Employment; Significant; Esperion Therapeutics, Inc. N.D. Lalwani: Employment; Significant; Esperion Therapeutics, Inc.
- © 2015 by American Heart Association, Inc.