| Title: |
Bempedoic acid and cardiovascular outcomes in statin-intolerant patients |
| Authors: |
Nissen, SEE; Lincoff, AM; Brennan, D; Ray, KKK; Mason, D; Kastelein, JJP; Thompson, PDD; Libby, P; Cho, L; Plutzky, J; Bays, HEE; Moriarty, PMM; Menon, V; Grobbee, DEE; Louie, MJJ; Chen, C-F; Li, N; Bloedon, LA; Robinson, P; Horner, M; Sasiela, WJJ; McCluskey, J; Davey, D; Fajardo-Campos, P; Petrovic, P; Fedacko, J; Zmuda, W; Lukyanov, Y; Nicholls, SJJ; CLEAR, OI |
| Source: |
12 ; 1 |
| Publisher Information: |
Massachusetts Medical Society |
| Publication Year: |
2023 |
| Collection: |
Imperial College London: Spiral |
| Description: |
BACKGROUND 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. METHODS 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. RESULTS 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, ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
New England Journal of Medicine; http://hdl.handle.net/10044/1/103990 |
| DOI: |
10.1056/NEJMoa2215024 |
| Availability: |
http://hdl.handle.net/10044/1/103990; https://doi.org/10.1056/NEJMoa2215024 |
| Rights: |
Copyright © 2023 Massachusetts Medical Society. All rights reserved. |
| Accession Number: |
edsbas.4A5E67E3 |
| Database: |
BASE |