Financiado en parte por Sanofi, Regeneron Pharmaceuticals
Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Quintero K, Roe MT, Sasiela WJ, Tamby JF, Tricoci P, White HD, Zeiher AM, ODYSSEY OUTCOMES Committees and Investigators
The New England journal of medicine · 2,735 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Sanofi
- Empresa
- Regeneron Pharmaceuticals
Según 2 financiadores declarados.
Publicación
- Publicado
- 2018-11-07 · N Engl J Med · vol. 379 · número 22 · págs. 2097–2107
- Editorial
- Massachusetts Medical Society
- Citado
- 3,618 citas · más que el 100% de estudios similares · 329.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 22 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Acute Myocardial Infarction Research · Antiplatelet Therapy and Cardiovascular Diseases
- Palabras clave
- alirocumab, PCSK9 inhibitors, acute coronary syndrome, cardiovascular outcomes, LDL cholesterol lowering, high-intensity statin therapy, LDL cholesterol targets, cardiovascular mortality, myocardial infarction, ischemic stroke, unstable angina, apolipoprotein B, non-HDL cholesterol, secondary prevention, cardiovascular risk reduction, LDL-C lowering therapy
- MeSH
- humans, cardiovascular diseases, hypercholesterolemia, antibodies, monoclonal, anticholesteremic agents, follow-up studies, double-blind method, adult, aged, middle aged, female, male, cholesterol, ldl, acute coronary syndrome, antibodies, monoclonal, humanized, proprotein convertase 9, pcsk9 inhibitors
22 autores
- Gregory G. Schwartz🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz; University of Colorado Denver
- Philippe Gabríel Steg🇫🇷🇬🇧🇺🇸Inserm; Sorbonne Paris Cité; Royal Brompton Hospital; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; Imperial College London; University of Colorado Anschutz
- Michael J. Szarek🇺🇸🇫🇷State University of New York; Inserm; SUNY Downstate Health Sciences University; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Deepak L. Bhatt🇺🇸🇫🇷Brigham and Women's Hospital; Harvard University; Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Vera Bittner🇫🇷🇺🇸Inserm; University of Alabama at Birmingham; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Rafael Díaz🇫🇷🇦🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Instituto Cardiovascular de Rosario; Université Paris Diderot; University of Colorado Anschutz
- Jay M. Edelberg🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Sanofi (United States); Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Shaun G. Goodman🇨🇦🇫🇷🇺🇸St. Michael's Hospital; University of Alberta; Inserm; University of Toronto; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Canadian VIGOUR Centre; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Corinne Hanotin🇫🇷🇺🇸Inserm; Sanofi (France); Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Robert A. Harrington🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Stanford Medicine; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz; Stanford University
- J. Wouter Jukema🇫🇷🇳🇱🇺🇸Inserm; Leiden University Medical Center; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Guillaume Lecorps🇫🇷🇺🇸Inserm; Sanofi (France); Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Kenneth W. Mahaffey🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Stanford Medicine; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz; Stanford University
- Angèle Moryusef🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Sanofi (United States); Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Robert C. Pordy🇫🇷🇺🇸Inserm; Regeneron (United States); Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Kirby Quintero🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Duke Medical Center; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Matthew T. Roe🇫🇷🇺🇸Inserm; Duke University; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Duke Medical Center; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- William J. Sasiela🇫🇷🇺🇸Inserm; Regeneron (United States); Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Jean‐François Tamby🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Sanofi (United States); Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Pierluigi Tricoci🇫🇷🇺🇸Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Duke Medical Center; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Harvey Douglas White🇫🇷🇳🇿🇺🇸Inserm; Auckland City Hospital; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
- Andreas Michael Zeiher🇩🇪🇫🇷🇺🇸Goethe University Frankfurt; Inserm; Sorbonne Paris Cité; Assistance Publique – Hôpitaux de Paris; Hôpital Bichat-Claude-Bernard; Université Paris Diderot; University of Colorado Anschutz
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Patients who have had an acute coronary syndrome are at high risk for recurrent ischemic cardiovascular events. We sought to determine whether alirocumab, a human monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9), would improve cardiovascular outcomes after an acute coronary syndrome in patients receiving high-intensity statin therapy.
Methods
We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an acute coronary syndrome 1 to 12 months earlier, had a low-density lipoprotein (LDL) cholesterol level of at least 70 mg per deciliter (1.8 mmol per liter), a non-high-density lipoprotein cholesterol level of at least 100 mg per deciliter (2.6 mmol per liter), or an apolipoprotein B level of at least 80 mg per deciliter, and were receiving statin therapy at a high-intensity dose or at the maximum tolerated dose. Patients were randomly assigned to receive alirocumab subcutaneously at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks. The dose of alirocumab was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter (0.6 to 1.3 mmol per liter). The primary end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.
Results
The median duration of follow-up was 2.8 years. A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001). A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (hazard ratio, 0.85; 95% CI, 0.73 to 0.98). The absolute benefit of alirocumab with respect to the composite primary end point was greater among patients who had a baseline LDL cholesterol level of 100 mg or more per deciliter than among patients who had a lower baseline level. The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group).
Conclusions
Among patients who had a previous acute coronary syndrome and who were receiving high-intensity statin therapy, the risk of recurrent ischemic cardiovascular events was lower among those who received alirocumab than among those who received placebo. (Funded by Sanofi and Regeneron Pharmaceuticals; ODYSSEY OUTCOMES ClinicalTrials.gov number, NCT01663402 .).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.