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Health Canada approval of low-dose colchicine for cardiovascular disease based on the COLCOT study

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MYINFLA™ 0.5 mg has been approved by Health Canada for the reduction of cardiovascular risk in patients with coronary disease

MONTREAL, Aug. 27, 2021 (GLOBE NEWSWIRE) -- People with coronary disease now have a new treatment option to reduce the risk of cardiovascular events. Health Canada has issued a Notice of Compliance for the prescription drug MYINFLA™ (colchicine 0.5 mg tablets) based on the results of the Montreal Heart Institute (MHI)’s COLCOT clinical trial.

Led by Dr. Jean-Claude Tardif, the COLCOT clinical trial compared colchicine to a placebo, as a complement to standard therapy, for the prevention of ischemic cardiovascular events in patients having recently experienced a myocardial infarction (also known as a heart attack).

Published in the prestigious New England Journal of Medicine, the results demonstrated the high efficacy of colchicine, which, when added to standard treatment in patients with myocardial infarction, significantly reduces cardiovascular risk.

Therefore, treatment with colchicine reduces the risk of a first ischemic cardiovascular event by 23% and the risk of overall ischemic events by 34% in patients having suffered a myocardial infarction1.

“Health Canada's approval of low-dose colchicine (0.5 mg) based on the results of our COLCOT study will allow patients with coronary artery disease to reduce their risk of cardiovascular events,” said Dr. Jean-Claude Tardif, director of the MHI Research Centre, professor of medicine at Université de Montréal and COLCOT principal investigator. “We are pleased that Health Canada has recognized the efficacy and safety of low-dose colchicine for the prevention of atherothrombotic events.”

Repositioning existing drugs
Cardiovascular disease is one of the leading causes of death and hospitalization in Canada. While prevention plays a major role in reducing cardiovascular risk, research into the repositioning of existing drugs remains critical to find new therapeutic avenues to improve patient health in a prompt and affordable manner.

“Health Canada's Notice of Compliance demonstrates the importance of taking advantage of the knowledge we have about existing drugs," says Dr. Jean-Claude Tardif. “By discovering new therapeutic applications to well-known drugs, we can generate a positive impact on the health of Canadians in a timely and cost-effective manner," he concludes.

Colchicine, the active ingredient in MYINFLA™, is already used as a treatment for gout, pericarditis and Familial Mediterranean fever. Health Canada approved the drug on August 25, 2021. MYINFLA (colchicine 0.5 mg extended-release) is indicated for the reduction of atherothrombotic events in adults with existing coronary artery disease, in addition to standard therapies including LDL-cholesterol ("bad cholesterol") lowering and antithrombotic therapy.

About the COLCOT (COLchicine Cardiovascular Outcomes Trial) Study
COLCOT is a randomized, double-blind clinical study comparing the daily intake of 0.5 mg of colchicine with a placebo, in addition to standard care. Coordinated by the Montreal Health Innovations Coordinating Center (MHICC), it took place in 167 research sites located in 12 countries.

The study primary efficacy endpoint was a combination of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, and urgent hospitalization for angina requiring coronary revascularization. Patients were treated according to national guidelines including intensive use of statins.

The events contributing to the efficacy criteria for the study were evaluated and confirmed by an independent adjudication committee made up of cardiologists and neurologists. The clinical trial was overseen by an independent data safety monitoring committee.

Within 30 days of their myocardial infarction, the 4745 COLCOT patients were randomly assigned to receive 0.5 mg colchicine or a placebo daily, in addition to their standard treatment. They were then followed over a median period of 23 months. Patients who received colchicine at a daily dose of 0.5 mg had significantly lower rates of ischemic cardiovascular events (first and recurrent) than those receiving placebo.

About the Montreal Heart Institute
Founded in 1954, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest cardiology research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the Université de Montréal and has more than 2000 employees, including 245 physicians and more than 85 researchers. icm-mhi.org

About the Montreal Health Innovations Coordinating Center (MHICC)
The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing. mhicc.org

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. Bouabdallaoui N, Tardif JC, Waters DD, et al. Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J 2020;41:4092-4099.

3. Samuel M, Tardif JC, Khairy P, et al. Cost-effectiveness of low-dose colchicine after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J - Qual Care Clin Outcomes 2020.

4. Samuel M, Tardif JC, Bouabdallaoui N, et al. Colchicine for secondary prevention of cardiovascular disease: A systematic review and meta-analysis of randomized controlled trials. Can J Cardiol 2021;37:776-785.

5. Nidorf SM, Fiolet ATL, Mosterd A, et al. Colchicine in patients with chronic coronary disease. N Engl J Med 2020;383:1838-47.

6. Fiolet ATL, Opstal TSJ, Mosterd A, et al. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J 2021;42:2765-2775.

7. Tardif JC, Marquis-Gravel G. Low-dose colchicine for the management of coronary artery disease. J Am Coll Cardiol 2021;78:867-869.

Information about pharmaceutical products which is included in this press release is not intended to constitute an advertisement or medical advice.

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Camille Turbide
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