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https://hdl.handle.net/2440/131651
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dc.contributor.author | Nicholls, S.J. | - |
dc.contributor.author | Lincoff, A.M. | - |
dc.contributor.author | Bays, H.E. | - |
dc.contributor.author | Cho, L. | - |
dc.contributor.author | Grobbee, D.E. | - |
dc.contributor.author | Kastelein, J.J. | - |
dc.contributor.author | Libby, P. | - |
dc.contributor.author | Moriarty, P.M. | - |
dc.contributor.author | Plutzky, J. | - |
dc.contributor.author | Ray, K.K. | - |
dc.contributor.author | Thompson, P.D. | - |
dc.contributor.author | Sasiela, W. | - |
dc.contributor.author | Mason, D. | - |
dc.contributor.author | McCluskey, J. | - |
dc.contributor.author | Davey, D. | - |
dc.contributor.author | Wolski, K. | - |
dc.contributor.author | Nissen, S.E. | - |
dc.date.issued | 2020 | - |
dc.identifier.citation | American Heart Journal, 2020; 235:104-112 | - |
dc.identifier.issn | 0002-8703 | - |
dc.identifier.issn | 1097-6744 | - |
dc.identifier.uri | http://hdl.handle.net/2440/131651 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | StephenJ Nicholls, A Michael Lincoff, Harold E Bays, Leslie Cho, Diederick E Grobbee, John JP Kastelein ... et al. | - |
dc.language.iso | en | - |
dc.publisher | Elsevier | - |
dc.rights | © 2020 Elsevier Inc. All rights reserved. | - |
dc.source.uri | http://dx.doi.org/10.1016/j.ahj.2020.10.060 | - |
dc.subject | Humans | - |
dc.subject | Cardiovascular Diseases | - |
dc.subject | Dicarboxylic Acids | - |
dc.subject | Fatty Acids | - |
dc.subject | Hydroxymethylglutaryl-CoA Reductase Inhibitors | - |
dc.subject | Treatment Outcome | - |
dc.subject | Incidence | - |
dc.subject | Double-Blind Method | - |
dc.subject | Drug Tolerance | - |
dc.subject | Aged | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Cholesterol, LDL | - |
dc.subject | Hypolipidemic Agents | - |
dc.subject | Global Health | - |
dc.subject | Biomarkers | - |
dc.title | Rationale and design of the CLEAR-outcomes trial: Evaluating the effect of Bempedoic acid on cardiovascular events in patients with statin intolerance | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1016/j.ahj.2020.10.060 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Nicholls, S.J. [0000-0002-9668-4368] | - |
Appears in Collections: | Aurora harvest 4 Medicine publications |
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