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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
Statement of
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
Double-Blind Method
Drug Tolerance
Cholesterol, LDL
Hypolipidemic Agents
Global Health
Rights: © 2020 Elsevier Inc. All rights reserved.
DOI: 10.1016/j.ahj.2020.10.060
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