Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients with Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol.

Autor: Ballantyne CM; Section of Cardiovascular Research, Department of Medicine, Baylor College of Medicine, Houston, Texas. Electronic address: cmb@bcm.edu., Shah S; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Kher U; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Hunter JA; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Gill GG; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Cressman MD; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Ashraf TB; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Johnson-Levonas AO; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey., Mitchel YB; Merck Research Laboratories, Global Clinical Development, Cardiovascular Disease, Kenilworth, New Jersey.
Jazyk: angličtina
Zdroj: The American journal of cardiology [Am J Cardiol] 2017 Feb 01; Vol. 119 (3), pp. 388-396. Date of Electronic Publication: 2016 Nov 01.
DOI: 10.1016/j.amjcard.2016.10.032
Abstrakt: To assess the effects of anacetrapib added to statin ± other lipid-modifying therapies in patients with hypercholesterolemia and not at their low-density lipoprotein cholesterol (LDL-C) goal (as per National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] guidelines) and in those with low high-density lipoprotein cholesterol (HDL-C). Patients on a stable dose of moderate/high-intensity statin ± other lipid-modifying therapies with LDL-C ≥70, ≥100, ≥130, or ≥160 mg/dl for very high, high, moderate, and low coronary heart disease risk, respectively, or at LDL-C goal with HDL-C ≤40 mg/dl, were randomized 1:1:1, stratified by background therapy use, to anacetrapib 100 mg (n = 153), anacetrapib 25 mg (n = 152), or placebo (n = 154) for 24 weeks, followed by a 12-week off-drug reversal phase. The primary end points were percent change from baseline in LDL-C (beta-quantification method) and HDL-C, as well as the safety profile of anacetrapib. Both doses of anacetrapib reduced LDL-C, non-HDL-C, apolipoprotein (Apo) B, and lipoprotein a and increased HDL-C and Apo AI versus placebo (p <0.001 for all). There were no meaningful differences between the anacetrapib 25 mg, 100 mg, and placebo groups in the proportions of discontinuations due to drug-related adverse events (0.7%, 1.3% vs 1.3%) or in abnormalities in liver enzymes (0%, 0% vs 0.7%), creatine kinase elevations overall (0%, 0.7% vs 0%) or with muscle symptoms (none seen), blood pressure, electrolytes, or adjudicated cardiovascular events (0.7%, 0.7% vs 1.3%). In conclusion, treatment with anacetrapib resulted in substantial reductions in LDL-C and increases in HDL-C and was generally well tolerated.
(Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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