Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial
| Autor: | P. Barton Duell, Narendra D. Lalwani, Erik S.G. Stroes, Xin Zhao, Le Anne T. Bloedon, Pragna M. Patel, Lawrence A. Leiter, Seth J. Baum, Jeffrey C. Hanselman, Anne C. Goldberg |
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| Přispěvatelé: | Experimental Vascular Medicine, Vascular Medicine, ACS - Atherosclerosis & ischemic syndromes |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Randomization Hyperlipidemia Familial Combined Familial hypercholesterolemia Placebo 01 natural sciences law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Internal medicine Hyperlipidemia Clinical endpoint Medicine Humans Dicarboxylic Acids 030212 general & internal medicine 0101 mathematics Adverse effect Aged business.industry Anticholesteremic Agents 010102 general mathematics Fatty Acids General Medicine Cholesterol LDL Middle Aged medicine.disease Atherosclerosis Clinical trial Cardiovascular Diseases Drug Therapy Combination Female Hydroxymethylglutaryl-CoA Reductase Inhibitors business |
| Zdroj: | JAMA, 322(18), 1780-1788. American Medical Association |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.2019.16585 |
| Popis: | Importance: Additional treatment options are needed for patients who do not achieve sufficient reduction in low-density lipoprotein cholesterol (LDL-C) level with available lipid-lowering therapies. Objective: To assess the efficacy of bempedoic acid vs placebo in patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy. Design, Setting, and Participants: Phase 3, randomized, double-blind, placebo-controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018. A total of 779 patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both met randomization criteria, which included LDL-C level 70 mg/dL (1.8 mmol/L) or greater while receiving maximally tolerated lipid-lowering therapy. Interventions: Patients were randomized 2:1 to treatment with bempedoic acid (180 mg) (n = 522) or placebo (n = 257) once daily for 52 weeks. Main Outcomes and Measures: The primary end point was percent change from baseline in LDL-C level at week 12. Secondary measures included changes in levels of lipids, lipoproteins, and biomarkers. Results: Among 779 randomized patients (mean age, 64.3 years; 283 women [36.3%]), 740 (95.0%) completed the trial. At baseline, mean LDL-C level was 120.4 (SD, 37.9) mg/dL. Bempedoic acid lowered LDL-C levels significantly more than placebo at week 12 (-15.1% vs 2.4%, respectively; difference, -17.4% [95% CI, -21.0% to -13.9%]; P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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