MONTREAL, Nov. 16, 2019 (GLOBE NEWSWIRE) -- The Montreal Heart Institute (MHI) today announced results from the COLchicine Cardiovascular Outcomes Trial (COLCOT) which compared colchicine to placebo on top of standard of care in preventing ischemic cardiovascular events in patients with a recent myocardial infarction (MI). In this study, patients receiving colchicine 0.5mg daily had a significantly lower rate of first and total (first and recurrent) ischemic cardiovascular events than those on placebo 1 . These data are simultaneously published in the New England Journal of Medicine (NEJM) and presented today at the American Heart Association (AHA) late-breaking Scientific Session.

The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke or urgent hospitalization for angina requiring coronary revascularization 1 . Patients were also treated according to national guidelines that included the intensive use of statins 1 .

Treatment with colchicine resulted in a:

  • 23% reduction in the risk of a first event of the primary efficacy endpoint; with event rates of 5.5% with colchicine and 7.1% with placebo (HR, 0.77; 95% CI, 0.61-0.96; p=0.02) 1 .   
  • 34% reduction in the risk of total (first and recurrent) events of the primary efficacy endpoint (RR, 0.66, 95% CI, 0.51-0.86, p=0.002) 1 .  
  • 29% reduction in the risk of a first event of the primary efficacy endpoint in patients who adhered to the protocol; with event rates of 5.1% with colchicine and 7.1% with placebo (HR, 0.71; 95% CI, 0.56-0.90) 1 .

“COLCOT exemplifies how to bring innovation in a time- and cost-effective manner to patients by repurposing older drugs,” said Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, Professor of Medicine at the University of Montreal, and COLCOT primary investigator. “These data underscore the potential of colchicine as an efficient and critically needed therapy for reducing inflammation post-myocardial infarction to improve patient cardiovascular outcomes.”

In COLCOT, 4,745 patients were randomized within 30 days of an MI to receive colchicine 0.5mg daily or placebo, on top of their standard of care, and were followed for a median of 23 months 1 . Colchicine was generally well-tolerated with nausea in 1.8% and 1.0% (p=0.02) of patients in the colchicine and placebo groups respectively 1 . Pneumonia was reported as a serious adverse event in 0.9% of colchicine patients compared with 0.4% in the placebo group (p=0.03).

About the COLchicine Cardiovascular Outcomes Trial (COLCOT)

Colchicine is an orally administered anti-inflammatory medication that is currently indicated for the management of pericarditis, gout, familial Mediterranean fever. COLCOT was a randomized, double-blind, placebo-controlled, investigator-initiated trial comparing colchicine 0.5 mg once daily with placebo on top of standard of care in a 1:1 ratio across 167 sites in 12 countries. The colchicine used in this trial was provided by Pharmascience Inc., Canada. The Montreal Health Innovations Coordinating Center (MHICC) coordinated the study and conducted the statistical analyses. Study endpoints were adjudicated by an independent clinical endpoint committee composed of cardiologists and neurologists. The trial was overseen by an independent data safety monitoring board.

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 research center in Canada, the largest cardiovascular prevention center in the country, and a cardiovascular genetics center. The Institute is affiliated with the University of Montreal and has more than 2,000 employees, including 245 doctors and more than 85 researchers.

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 4,500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials and drug repurposing.

References:

1.     Tardif J-C, Kouz S, Waters D, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019. Available at www.nejm.org

Information about pharmaceutical products (including products currently in research) which is included in this press, release is not intended to constitute an advertisement or medical advice.

Contacts:

For COLCOT (International medias)          Clare Evans                                                   Clare.evans@iriscommunication.net        +1 (403) 888 6869                                          For COLCOT and Montreal Heart Institute (Canadian medias) Marie-Claude Pageau marie-claude.pageau@icm- mhi.org +1 (514) 376 3330 p. 3834

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/Attach...5f43c122b7