Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients

医学 危险系数 安慰剂 冲程(发动机) 心肌梗塞 不利影响 他汀类 临床终点 入射(几何) 随机化 内科学 胃肠病学 随机对照试验 置信区间 心脏病学 外科 病理 替代医学 工程类 物理 光学 机械工程
作者
Steven E. Nissen,A. Michael Lincoff,Danielle M. Brennan,Kausik K. Ray,Denise Mason,John J.P. Kastelein,Paul D. Thompson,Peter Libby,Leslie Cho,Jorge Plutzky,Harold Bays,Patrick M. Moriarty,Venu Menon,Diederick E. Grobbee,Michael J. Louie,Chien‐Feng Chen,Na Li,LeAnne T. Bloedon,Paula Robinson,Maggie Horner,William J. Sasiela,James McCluskey,Deborah Davey,Pedro Fajardo-Campos,Predrag Petrović,Ján Fedačko,Witold Żmuda,Yury Lukyanov,Stephen J. Nicholls
出处
期刊:The New England Journal of Medicine [New England Journal of Medicine]
卷期号:388 (15): 1353-1364 被引量:403
标识
DOI:10.1056/nejmoa2215024
摘要

Bempedoic acid, an ATP citrate lyase inhibitor, reduces low-density lipoprotein (LDL) cholesterol levels and is associated with a low incidence of muscle-related adverse events; its effects on cardiovascular outcomes remain uncertain.We conducted a double-blind, randomized, placebo-controlled trial involving patients who were unable or unwilling to take statins owing to unacceptable adverse effects ("statin-intolerant" patients) and had, or were at high risk for, cardiovascular disease. The patients were assigned to receive oral bempedoic acid, 180 mg daily, or placebo. The primary end point was a four-component composite of major adverse cardiovascular events, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.A total of 13,970 patients underwent randomization; 6992 were assigned to the bempedoic acid group and 6978 to the placebo group. The median duration of follow-up was 40.6 months. The mean LDL cholesterol level at baseline was 139.0 mg per deciliter in both groups, and after 6 months, the reduction in the level was greater with bempedoic acid than with placebo by 29.2 mg per deciliter; the observed difference in the percent reductions was 21.1 percentage points in favor of bempedoic acid. The incidence of a primary end-point event was significantly lower with bempedoic acid than with placebo (819 patients [11.7%] vs. 927 [13.3%]; hazard ratio, 0.87; 95% confidence interval [CI], 0.79 to 0.96; P = 0.004), as were the incidences of a composite of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (575 [8.2%] vs. 663 [9.5%]; hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P = 0.006); fatal or nonfatal myocardial infarction (261 [3.7%] vs. 334 [4.8%]; hazard ratio, 0.77; 95% CI, 0.66 to 0.91; P = 0.002); and coronary revascularization (435 [6.2%] vs. 529 [7.6%]; hazard ratio, 0.81; 95% CI, 0.72 to 0.92; P = 0.001). Bempedoic acid had no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, and death from any cause. The incidences of gout and cholelithiasis were higher with bempedoic acid than with placebo (3.1% vs. 2.1% and 2.2% vs. 1.2%, respectively), as were the incidences of small increases in serum creatinine, uric acid, and hepatic-enzyme levels.Among statin-intolerant patients, treatment with bempedoic acid was associated with a lower risk of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization). (Funded by Esperion Therapeutics; CLEAR Outcomes ClinicalTrials.gov number, NCT02993406.).
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