Abstract
This phase 3, multiregional, randomized, double-blind, placebo-controlled study assessed the efficacy/safety profile of anacetrapib added to ongoing therapy with statin ± other lipid-modifying therapies in patients with hypercholesterolemia who were not at their low-density lipoprotein (LDL-C) goal (as per the National Cholesterol Education Program Adult Treatment Panel III guidelines) and in those with low high-density lipoprotein cholesterol (HDL-C). Patients on a stable dose of statin ± other lipid-modifying therapies and with LDL-C ≥70 to <115, ≥100 to <145, ≥130, or ≥160mg/dl for very high, high, moderate, or low CHD risk or at LDL-C goal (per CHD risk category) with HDL-C ≤40mg/dl were randomized in a ratio of 1:1 to anacetrapib 100mg (n= 290) or placebo (n= 293) for 24weeks, followed by a 12-week off-drug phase. The co-primary end points were % change from baseline in LDL-C and HDL-C and the safety profile of anacetrapib. Treatment with anacetrapib reduced LDL-C (BQ) by 37% (95% confidence interval-42.5,-31.0) and increased HDL-C by 118% (95% confidence interval 110.6, 125.7) relative to placebo (p <0.001 for both). Anacetrapib also reduced non-HDL-C, apolipoprotein B, and lipoprotein a and increased apolipoprotein AI versus placebo (p <0.001 for all). There were no clinically meaningful differences between the anacetrapib and placebo groups in the % patients who discontinued drug due to an adverse event or in abnormalities in liver enzymes, creatine kinase, blood pressure, electrolytes, or adjudicated cardiovascular events. Treatment with anacetrapib substantially reduced LDL-C and also increased HDL-C and was well tolerated over 24weeks in statin-treated patients with hypercholesterolemia or low HDL-C.
Highlights
This phase 3, multiregional, randomized, double-blind, placebo-controlled study assessed the efficacy/safety profile of anacetrapib added to ongoing therapy with statin – other lipidmodifying therapies in patients with hypercholesterolemia who were not at their lowdensity lipoprotein (LDL-C) goal and in those with low high-density lipoprotein cholesterol (HDL-C)
Previous studies have shown that cholesteryl ester transfer protein (CETP) inhibitors favorably modify plasma lipid profiles when administered in combination with statins, several investigational CETP inhibitors failed to show a benefit on aBaylor College of Medicine, Houston, Texas; bMerck & Co., Inc., Kenilworth, New Jersey; cKocaeli University Medical Faculty, Kocaeli, Turkey; dChina PLA General Hospital, Beijing, China; eThe First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China; fDivision of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan; gAsan Medical Center, Seoul, South Korea; hNucleo de Pesquisa Clinica, Parana, Brazil; iState Budgetary Healthcare Institution, Moscow, Russia; and jCardioarritmias e Investigacion
In contrast to most lipid studies, which include predominantly participants from North America and western Europe, this multicenter, randomized, double-blind study was conducted in the populous countries underrepresented in clinical trials (i.e., Brazil, Russia, China, Korea, Taiwan, Turkey, and Mexico) to compare the lipid-modifying efficacy and safety profile of anacetrapib 100 mg versus placebo added to ongoing optimal statin therapy (Æother lipid-modifying therapies [LMTs]) in patients with hypercholesterolemia who were not at their LDL-C goal and in those with low HDL-C
Summary
This phase 3, multiregional, randomized, double-blind, placebo-controlled study assessed the efficacy/safety profile of anacetrapib added to ongoing therapy with statin – other lipidmodifying therapies in patients with hypercholesterolemia who were not at their lowdensity lipoprotein (LDL-C) goal (as per the National Cholesterol Education Program Adult Treatment Panel III guidelines) and in those with low high-density lipoprotein cholesterol (HDL-C). In contrast to most lipid studies, which include predominantly participants from North America and western Europe, this multicenter, randomized, double-blind study was conducted in the populous countries underrepresented in clinical trials (i.e., Brazil, Russia, China, Korea, Taiwan, Turkey, and Mexico) to compare the lipid-modifying efficacy and safety profile of anacetrapib 100 mg versus placebo added to ongoing optimal statin therapy (Æother lipid-modifying therapies [LMTs]) in patients with hypercholesterolemia who were not at their LDL-C goal (as per the National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] guidelines) and in those with low HDL-C
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