Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
31733140
DOI
10.1056/nejmoa1912388
Knihovny.cz E-resources
- MeSH
- Intention to Treat Analysis MeSH
- Angina Pectoris epidemiology MeSH
- Anti-Inflammatory Agents administration & dosage adverse effects MeSH
- Biomarkers blood MeSH
- C-Reactive Protein analysis MeSH
- Stroke epidemiology MeSH
- Double-Blind Method MeSH
- Incidence MeSH
- Myocardial Infarction drug therapy therapy MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Diseases epidemiology mortality MeSH
- Colchicine administration & dosage adverse effects MeSH
- Percutaneous Coronary Intervention MeSH
- Middle Aged MeSH
- Humans MeSH
- Proportional Hazards Models MeSH
- Recurrence MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Anti-Inflammatory Agents MeSH
- Biomarkers MeSH
- C-Reactive Protein MeSH
- Colchicine MeSH
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.).
References provided by Crossref.org
ClinicalTrials.gov
NCT02551094