• Christie M Ballantyne, Maciej Banach, Mancini G B John GBJ Division of Cardiology, University of British Columbia, 2775 Laurel Street 10th Floor, Vancouver, V5Z 1M9, British Columbia, Canada., Norman E Lepor, Jeffrey C Hanselman, Xin Zhao, and Lawrence A Leiter.
• Department of Medicine, Baylor College of Medicine, One Baylor Plaza, BCM 285, Houston, TX, 77030, USA. Electronic address: cmb@bcm.edu.
• Atherosclerosis. 2018 Oct 1; 277: 195-203.

Background And AimsPatients with hyperlipidemia who are unable to tolerate optimal statin therapy are at increased cardiovascular risk due to ongoing elevations in low-density lipoprotein cholesterol (LDL-C). The objective of CLEAR Tranquility (NCT03001076) was to evaluate the efficacy and safety of bempedoic acid when added to background lipid-modifying therapy in patients with a history of statin intolerance who require additional LDL-C lowering.MethodsThis phase 3, multicenter, randomized, double-blind, placebo-controlled study enrolled patients with a history of statin intolerance and an LDL-C ≥100 mg/dL while on stable lipid-modifying therapy. After a 4-week ezetimibe 10 mg/day run-in period, patients were randomized 2:1 to treatment with bempedoic acid 180 mg or placebo once daily added to ezetimibe 10 mg/day for 12 weeks. The primary endpoint was the percent change from baseline to week 12 in LDL-C.ResultsThe study population comprised 269 patients (181 bempedoic acid, 88 placebo). Bempedoic acid added to background lipid-modifying therapy that included ezetimibe reduced LDL-C by 28.5% more than placebo (p < 0.001; -23.5% bempedoic acid, +5.0% placebo). Significant reductions in secondary endpoints, including non-high-density lipoprotein cholesterol (-23.6%), total cholesterol (-18.0%), apolipoprotein B (-19.3%), and high-sensitivity C-reactive protein (-31.0%), were observed with bempedoic acid vs. placebo (p < 0.001). Bempedoic acid was well tolerated; rates of treatment-emergent adverse events, muscle-related adverse events, and discontinuations were similar in the bempedoic acid and placebo treatment groups.ConclusionsBempedoic acid may provide an oral therapeutic option complementary to ezetimibe in statin intolerant patients who require additional LDL-C lowering.Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

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