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Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients.
Nissen, Steven E; Lincoff, A Michael; Brennan, Danielle; Ray, Kausik K; Mason, Denise; Kastelein, John J P; Thompson, Paul D; Libby, Peter; Cho, Leslie; Plutzky, Jorge; Bays, Harold E; Moriarty, Patrick M; Menon, Venu; Grobbee, Diederick E; Louie, Michael J; Chen, Chien-Feng; Li, Na; Bloedon, LeAnne; Robinson, Paula; Horner, Maggie; Sasiela, William J; McCluskey, Jackie; Davey, Deborah; Fajardo-Campos, Pedro; Petrovic, Predrag; Fedacko, Jan; Zmuda, Witold; Lukyanov, Yury; Nicholls, Stephen J.
Afiliación
  • Nissen SE; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Lincoff AM; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Brennan D; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Ray KK; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Mason D; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Kastelein JJP; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Thompson PD; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Libby P; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Cho L; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Plutzky J; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Bays HE; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Moriarty PM; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Menon V; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Grobbee DE; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Louie MJ; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Chen CF; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Li N; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Bloedon L; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Robinson P; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Horner M; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Sasiela WJ; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • McCluskey J; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Davey D; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Fajardo-Campos P; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Petrovic P; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Fedacko J; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Zmuda W; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Lukyanov Y; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
  • Nicholls SJ; From the Cleveland Clinic, Cleveland (S.E.N., A.M.L., D.B., D.M., L.C., V.M., J.M., D.D.); Imperial College London, London (K.K.R.); University of Amsterdam Academic Medical Center, Amsterdam (J.J.P.K.), and University Medical Center Utrecht, Utrecht (D.E.G.) - both in the Netherlands; Hartford Hosp
N Engl J Med ; 388(15): 1353-1364, 2023 Apr 13.
Article en En | MEDLINE | ID: mdl-36876740
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, 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. CONCLUSIONS: 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Cardiovasculares Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: N Engl J Med Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Cardiovasculares Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: N Engl J Med Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos