Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction
Jean‐Claude TardifFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in FranceSimon KouzFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) — all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici CardiologiDavid D. WatersFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in FranceOlivier F. BertrandCentre Hospitalier Universitaire de ToursRafael DíazUniversidad Autónoma de MadridAldo P. MaggioniCentre Hospitalier Universitaire de ToursFausto J. PintoUniversidad Autónoma de MadridRéda IbrahimMontreal Heart InstituteHabib GamraCentre Hospitalier Universitaire de ToursGhassan S. KiwanFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) — all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici CardiologiColin BerryFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) — all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici CardiologiJosé López‐SendónUniversidad Autónoma de MadridPetr OšťádalCentre Hospitalier Universitaire de ToursWolfgang KöenigCentre Hospitalier Universitaire de ToursDenis AngoulvantMontreal Heart InstituteJean C. GrégoireMontreal Heart InstituteMarc-André LavoieCentre Hospitalier Universitaire de ToursMarie‐Pierre DubéCentre Hospitalier Universitaire de ToursDavid RhaindsFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) - all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red-Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) - all in FranceMylène ProvencherFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) — all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici CardiologiLucie BlondeauMontreal Heart InstituteAndreas OrfanosFrom the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) — all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici CardiologiPhilippe L. L’AllierCentre Hospitalier Universitaire de ToursMarie‐Claude GuertinMontreal Heart InstituteFrançois RoubilleMontreal Heart Institute
2019en
Ochiq kirishBronza
ABI
Annotatsiya
BACKGROUND: Experimental and clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine is an orally administered, potent antiinflammatory medication that is indicated for the treatment of gout and pericarditis. METHODS: We performed a randomized, double-blind trial involving patients recruited within 30 days after a myocardial infarction. The patients were randomly assigned to receive either low-dose colchicine (0.5 mg once daily) or placebo. The primary efficacy end point was a composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization. The components of the primary end point and safety were also assessed. RESULTS: A total of 4745 patients were enrolled; 2366 patients were assigned to the colchicine group, and 2379 to the placebo group. Patients were followed for a median of 22.6 months. The primary end point occurred in 5.5% of the patients in the colchicine group, as compared with 7.1% of those in the placebo group (hazard ratio, 0.77; 95% confidence interval [CI], 0.61 to 0.96; P = 0.02). The hazard ratios were 0.84 (95% CI, 0.46 to 1.52) for death from cardiovascular causes, 0.83 (95% CI, 0.25 to 2.73) for resuscitated cardiac arrest, 0.91 (95% CI, 0.68 to 1.21) for myocardial infarction, 0.26 (95% CI, 0.10 to 0.70) for stroke, and 0.50 (95% CI, 0.31 to 0.81) for urgent hospitalization for angina leading to coronary revascularization. Diarrhea was reported in 9.7% of the patients in the colchicine group and in 8.9% of those in the placebo group (P = 0.35). Pneumonia was reported as a serious adverse event in 0.9% of the patients in the colchicine group and in 0.4% of those in the placebo group (P = 0.03). CONCLUSIONS: Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo. (Funded by the Government of Quebec and others; COLCOT ClinicalTrials.gov number, NCT02551094.).
Hali tarjima qilinmagan
Identifikatorlar
Iqtiboslar va manbalar
3 ta iqtibos0 ta foydalanilgan manba