{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T19:47:17Z","timestamp":1793908037204,"version":"4.8.0"},"reference-count":34,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"7","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2019,4,2]]},"abstract":"\n Background<\/jats:title>\n \n Inability to tolerate statins because of muscle symptoms contributes to uncontrolled cholesterol levels and insufficient cardiovascular risk reduction. Bempedoic acid, a prodrug that is activated by a hepatic enzyme not present in skeletal muscle, inhibits\n ATP<\/jats:styled-content>\n \u2010citrate lyase, an enzyme upstream of \u03b2\u2010hydroxy \u03b2\u2010methylglutaryl\u2010coenzyme A reductase in the cholesterol biosynthesis pathway.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and Results<\/jats:title>\n \n The phase 3, double\u2010blind, placebo\u2010controlled CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL\u2010Inhibiting Regimen) Serenity study randomized 345 patients with hypercholesterolemia and a history of intolerance to at least 2 statins (1 at the lowest available dose) 2:1 to bempedoic acid 180\u00a0mg or placebo once daily for 24\u00a0weeks. The primary end point was mean percent change from baseline to week 12 in low\u2010density lipoprotein cholesterol. The mean age was 65.2\u00a0years, mean baseline low\u2010density lipoprotein cholesterol was 157.6\u00a0mg\/dL, and 93% of patients reported a history of statin\u2010associated muscle symptoms. Bempedoic acid treatment significantly reduced low\u2010density lipoprotein cholesterol from baseline to week 12 (placebo\u2010corrected difference, \u221221.4% [95% CI, \u221225.1% to \u221217.7%];\n P<\/jats:italic>\n <0.001). Significant reductions with bempedoic acid versus placebo were also observed in non\u2013high\u2010density lipoprotein cholesterol (\u221217.9%), total cholesterol (\u221214.8%), apolipoprotein B (\u221215.0%), and high\u2010sensitivity C\u2010reactive protein (\u221224.3%;\n P<\/jats:italic>\n <0.001 for all comparisons). Bempedoic acid was safe and well tolerated. The most common muscle\u2010related adverse event, myalgia, occurred in 4.7% and 7.2% of patients who received bempedoic acid or placebo, respectively.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Bempedoic acid offers a safe and effective oral therapeutic option for lipid lowering in patients who cannot tolerate statins.<\/jats:p>\n <\/jats:sec>\n \n Clinical Trial Registration<\/jats:title>\n \n URL<\/jats:styled-content>\n :\n https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n . Unique identifier:\n NCT<\/jats:styled-content>\n 02988115.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/jaha.118.011662","type":"journal-article","created":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T05:01:50Z","timestamp":1553835710000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":386,"title":["Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance"],"prefix":"10.1161","volume":"8","author":[{"given":"Ulrich","family":"Laufs","sequence":"first","affiliation":[{"name":"Klinik und Poliklinik f\u00fcr Kardiologie Universit\u00e4tsklinikum Leipzig Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Banach","sequence":"additional","affiliation":[{"name":"Department of Hypertension Medical University of Lodz Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G. B. John","family":"Mancini","sequence":"additional","affiliation":[{"name":"Division of Cardiology University of British Columbia Vancouver British Columbia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Gaudet","sequence":"additional","affiliation":[{"name":"Lipidology Unit, Community Genomic Medicine Centre and ECOGENE\u201021 Department of Medicine Universit\u00e9 de Montr\u00e9al Saguenay Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"LeAnne T.","family":"Bloedon","sequence":"additional","affiliation":[{"name":"Esperion Therapeutics, Inc. Ann Arbor MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lulu Ren","family":"Sterling","sequence":"additional","affiliation":[{"name":"Esperion Therapeutics, Inc. Ann Arbor MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Kelly","sequence":"additional","affiliation":[{"name":"Esperion Therapeutics, Inc. 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