28 Dec Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction
MedicalResearch.com Interview with:
Dr. Tardif
Jean-Claude Tardif CM, MD, FRCPC, FCCS, FACC, FAHA, FESC, FCAHS
Director, Montrel Heart Institute Research Center
Professor of medicine
Canada Research Chair in translational and personalized medicine
University of Montreal endowed research chair in atherosclerosis
Montreal Heart Institute
MedicalResearch.com: What is the background for this study?
Response: Inflammation appears to play an important role in atherosclerosis. Inhibition of interleukin-1ß by canakinumab reduced the rate of cardiovascular events by 15% CANTOS. In contrast, methotrexate did not affect cardiovascular outcomes or plasma markers of inflammation in CIRT. Colchicine is an inexpensive, orally administered, potent anti-inflammatory medication that has been used for centuries. Colchicine is currently indicated for the management of patients with gout, familial Mediterranean fever and pericarditis. In the LODOCO study, patients with stable coronary disease treated with colchicine 0.5 mg once daily experienced fewer cardiovascular events as compared with those not receiving colchicine. However, that study enrolled only 532 patients and was not placebo-controlled. Because acute coronary syndromes are associated with higher risks of recurrent events and exacerbated inflammation, we conducted the COLchicine Cardiovascular Outcomes Trial (COLCOT) in patients with a recent myocardial infarction to evaluate the effects of colchicine on cardiovascular outcomes and its long-term safety and tolerability.
MedicalResearch.com: What are the main findings?
Response: COLCOT was a double-blind, placebo-controlled, randomized clinical trial of 4745 patients recruited within 30 days after myocardial infarction. Patients were treated according to national guidelines (99% aspirin, 98% a second anti-platelet agent, 99% statin, 93% PCI) and randomly assigned to receive colchicine 0.5 mg daily or placebo. Median follow-up was 22.6 months. Colchicine reduced the risk of the primary composite endpoint of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke or urgent hospitalization for angina requiring coronary revascularization by 23% compared to placebo (p=0.02). The rate of total (first and recurrent) primary endpoint events was reduced by 34% with colchicine (rate ratio vs. placebo, 0.66; 95% CI, 0.51 to 0.86). Colchicine was well tolerated. A nominally higher incidence of diarrhea occurred with colchicine than placebo (9.7% versus 8.9%, p=0.35). Pneumonia was reported as a serious adverse event in 0.9% and 0.4% of patients in the colchicine and placebo groups, respectively (p=0.03).
MedicalResearch.com: What should readers take away from your report?
Response: Colchicine at the low dose of 0.5 mg daily led to a significantly lower rate of ischemic cardiovascular events than placebo among patients with a recent myocardial infarction.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The COLCOT results apply to patients who have recently suffered a myocardial infarction. Further research is needed to assess the benefits of colchicine in other high-risk patients. The LODOCO2 trial of patients with stable coronary disease will be reported in September 2020. We will be launching early in 2020 the COLCOT-T2D trial of 10,000 patients with type 2 diabetes but without known coronary disease.
Citation:
Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction
Jean-Claude Tardif, M.D., Simon Kouz, M.D., David D. Waters, M.D., Olivier F. Bertrand, M.D., Ph.D., Rafael Diaz, M.D., Aldo P. Maggioni, M.D., Fausto J. Pinto, M.D., Ph.D., Reda Ibrahim, M.D., Habib Gamra, M.D., Ghassan S. Kiwan, M.D., Colin Berry, M.D., Ph.D., José López-Sendón, M.D., et al
N Engl J Med 2019; 381:2497-2505
DOI: 10.1056/NEJMoa1912388
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Last Updated on December 28, 2019 by Marie Benz MD FAAD