Efficacy and safety of low-dose colchicine after myocardial infarction
Autor: | Lucie Blondeau, Mylène Provencher, Olivier F. Bertrand, Aldo P. Maggioni, José López-Sendón, Jean-Claude Tardif, François Roubille, Simon Kouz, Wolfgang Koenig, Marie-Pierre Dubé, Rafael Diaz, Andreas Orfanos, Reda Ibrahim, Denis Angoulvant, Petr Ostadal, Fausto J. Pinto, Jean Grégoire, Ghassan S. Kiwan, Marie-Claude Guertin, David D. Waters, Marc-André Lavoie, David Rhainds, Colin Berry, Habib Gamra, Philippe L. L’Allier |
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Přispěvatelé: | Montreal Heart Institute Coordinating Centre (MHICC), Université de Montréal (UdeM), Montreal Heart Institute, Montreal, Canada, Université Laval [Québec] (ULaval), Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, USA., Institut de Cardiologie et Pneumologie de Québec, Quebec City, ECLAEstudios Clínicos Latino América & Instituto Cardiovascular de Rosario), Rosario, Argentina, Research Center [Associazione Nazionale Medici Cardiologi Ospedalieri] (ANMCO Research Center), Associazione Nazionale Medici Cardiologi Ospedalieri [Firenze] (ANMCO), Cardiology Department, CHULN, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal, Montrea l Heart Institute, Université de Montréal, Montreal, Canada, CHU Fattouma Bourguiba [Monastir] (HFB), Bellevue Medical Center, Beirut, Lebanon, Institute of Cardiovascular and Medical Sciences, University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre (BHF GCRC), University of Glasgow-NHS Greater Glasgow and Clyde, Cardiology department Hospital Universitario La Paz. UAM. IdiPaz. CIBER-CV, Madrid, Spain, Department of Cardiology Cardiovascular Center, NaHomolce Hospital, Prague, Czech Republic, Department of Internal Medicine II – Cardiology, Universität Ulm - Ulm University [Ulm, Allemagne], München, Technische Universität München, German Research Center for Cardiovascular Disease (DZHK), Partner site Munich Heart Alliance, Institute of Epidemiology and Medical Biometry, University of Ulm, Munich, Germany, Cellules Dendritiques, Immunomodulation et Greffes, Université de Tours (UT), Centre Hospitalier Universitaire (CHU) de Tours and Équipe d'Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Montreal Heart Institute - Institut de Cardiologie de Montréal, Montreal Health Innovations Coordinating Center [Montreal Heart Institute] (MHICC), Montreal Health Innovation Coordination Center, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), MORNET, Dominique, Repositório da Universidade de Lisboa, Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS) |
Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
Male
medicine.medical_treatment [SDV]Life Sciences [q-bio] Myocardial Infarction Anti-Inflammatory Agents Inflammation Kaplan-Meier Estimate 030204 cardiovascular system & hematology Pharmacology Medical and Health Sciences law.invention Angina Pectoris 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Percutaneous Coronary Intervention Randomized controlled trial Double-Blind Method law Recurrence General & Internal Medicine medicine Colchicine Humans 030212 general & internal medicine Myocardial infarction Proportional Hazards Models Aged Intention-to-treat analysis business.industry Incidence Low dose Percutaneous coronary intervention General Medicine Middle Aged medicine.disease 3. Good health Intention to Treat Analysis Stroke [SDV] Life Sciences [q-bio] C-Reactive Protein chemistry Clinical evidence Cardiovascular Diseases Female medicine.symptom business Biomarkers |
Zdroj: | Repositório Científico de Acesso Aberto de Portugal Repositório Científico de Acesso Aberto de Portugal (RCAAP) instacron:RCAAP New England Journal of Medicine New England Journal of Medicine, 2019, ⟨10.1056/NEJMoa1912388⟩ The New England journal of medicine, vol 381, iss 26 New England Journal of Medicine, Massachusetts Medical Society, 2019, ⟨10.1056/NEJMoa1912388⟩ |
ISSN: | 0028-4793 1533-4406 |
Popis: | Copyright © 2019 Massachusetts Medical Society. All rights reserved. Background: Experimental and clinical evidence support 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.). |
Databáze: | OpenAIRE |
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