The Montreal Heart Institute Welcomes FDA Approval of Colchicine for the Treatment of Cardiovascular Diseases

MONTREAL, June 23, 2023 (GLOBE NEWSWIRE) — The Montreal Heart Institute (MHI) welcomes the approval by the United States Food and Drug Administration (FDA) of colchicine for cardiovascular prevention. Low-dose colchicine (0.5 mg once daily) is the first approved anti-inflammatory medication to reduce the risk of myocardial infarction (heart attack), stroke, coronary revascularization, and cardiovascular death in adult patients with atherosclerotic coronary artery disease, which consists in deposits potentially causing narrowing of arteries.

Two large cardiovascular clinical studies have been conducted with colchicine: COLCOT, conducted by Dr. Jean-Claude Tardif, Director of Research at the Montreal Heart Institute, and LoDoCo-2, led by Dr. Stefan M. Nidorf from Australia.

“We have known for a long time that inflammation contributes to atherosclerosis and increases cardiovascular risk. Our COLCOT study and the LoDoCo2 study have demonstrated that by treating inflammation, we can reduce the risk of cardiovascular events in patients who have already experienced a heart attack. The FDA’s approval of colchicine confirms that we are entering a new era of patient care, now targeting inflammation as an underlying cause of atherosclerotic coronary artery disease,” said Dr. Jean-Claude Tardif.

COLCOT
Conducted by Dr. Jean-Claude Tardif, this large clinical study compared low-dose colchicine to placebo on top of standard treatment in patients who recently experienced a myocardial infarction. The results, published in the New England Journal of Medicine, demonstrated that colchicine significantly reduces cardiovascular risks. Treatment with colchicine reduced the risk of a new ischemic cardiovascular event by 23% and the risk of total ischemic events by 34% in patients who had a myocardial infarction. The study notably led to the approval of colchicine by Health Canada in August 2021 to reduce the risk of ischemic cardiovascular events in patients who have coronary artery disease.

LoDoCo-2
While the COLCOT study focused on inflammation in patients who had already experienced a myocardial infarction, the LoDoCo-2 study targeted patients with stable atherosclerotic cardiovascular disease. The results of this study demonstrated that colchicine reduced the risk of cardiovascular events by 31% when added to standard prevention treatments in these patients.

About the Montreal Heart Institute
Founded in 1954, the Montreal Heart Institute continually strives for the highest standards of excellence in the cardiovascular field through its leadership in clinical and fundamental research, specialized care, professional training, and prevention. It is home to Canada’s largest cardiovascular research center, largest cardiovascular prevention center, and largest cardiovascular genetics center. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 physicians and over 85 researchers.

References :

1. Tardif JC, Kouz S, Waters D, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019;381:2497-2505; available at nejm.org
2. Stefan M. Nidorf, Aernoud T.L. Fiolet, Arend Mosterd, et al. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med 2020; 383:1838-1847; available at nejm.org

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