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https://hdl.handle.net/2440/131651
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Type: | Journal article |
Title: | Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance |
Author: | Nicholls, S.J. Lincoff, A.M. Bays, H.E. Cho, L. Grobbee, D.E. Kastelein, J.J. Libby, P. Moriarty, P.M. Plutzky, J. Ray, K.K. Thompson, P.D. Sasiela, W. Mason, D. McCluskey, J. Davey, D. Wolski, K. Nissen, S.E. |
Citation: | American Heart Journal, 2020; 235:104-112 |
Publisher: | Elsevier |
Issue Date: | 2020 |
ISSN: | 0002-8703 1097-6744 |
Statement of Responsibility: | StephenJ Nicholls, A Michael Lincoff, Harold E Bays, Leslie Cho, Diederick E Grobbee, John JP Kastelein ... et al. |
Abstract: | Background: Although statins play a pivotal role in the prevention of atherosclerotic cardiovascular disease, many patients fail to achieve recommended lipid levels due to statin-associated muscle symptoms. Bempedoic acid is an oral pro-drug that is activated in the liver and inhibits cholesterol synthesis in hepatocytes, but is not activated in skeletal muscle which has the potential to avoid muscle-related adverse events. Accordingly, this agent effectively lowers atherogenic lipoproteins in patients who experience statin-associated muscle symptoms. However, the effects of bempedoic acid on cardiovascular morbidity and mortality have not been studied. Study design: Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes is a randomized, double-blind, placebo-controlled clinical trial. Included patients must have all of the following: (i) established atherosclerotic cardiovascular disease or have a high risk of developing atherosclerotic cardiovascular disease, (ii) documented statin intolerance, and (iii) an LDL-C≥100mg/dL on maximally-tolerated lipid-lowering therapy. The study randomized 14,014 patients to treatment with bempedoic acid 180mg daily or matching placebo on a background of guideline-directed medical therapy. The primary outcome is a composite of the time to first cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. The trial will continue until 1620 patients experience a primary endpoint, with a minimum of 810 hard ischemic events (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) and minimum treatment duration of 36months and a projected median treatment exposure of 42months. Conclusions: CLEAR Outcomes will determine whether bempedoic acid 180mg daily reduces the incidence of adverse cardiovascular events in high vascular risk patients with documented statin intolerance and elevated LDL-C levels. |
Keywords: | Humans Cardiovascular Diseases Dicarboxylic Acids Fatty Acids Hydroxymethylglutaryl-CoA Reductase Inhibitors Treatment Outcome Incidence Double-Blind Method Drug Tolerance Aged Female Male Cholesterol, LDL Hypolipidemic Agents Global Health Biomarkers |
Rights: | © 2020 Elsevier Inc. All rights reserved. |
DOI: | 10.1016/j.ahj.2020.10.060 |
Published version: | http://dx.doi.org/10.1016/j.ahj.2020.10.060 |
Appears in Collections: | Aurora harvest 4 Medicine publications |
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