Colchicine also being evaluated as a treatment to prevent complications and death related to severe cases of COVID-19 by the Montreal Heart Institute
MONTREAL, Aug. 29, 2020 /PRNewswire/ — Data presented today at the virtual European Society of Cardiology (ESC) Congress late-breaking science session from the COLchicine Cardiovascular Outcomes Trial (COLCOT) shows that a daily dose of colchicine (0.5mg) on top of standard of care significantly reduces the risk of a first ischemic cardiovascular event by nearly half (48%) when given to patients within three days following a heart attack, also known as a myocardial infarction (MI)1. These data have also been published simultaneously in the European Heart Journal1.
The primary efficacy endpoint for COLCOT was a combination of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina requiring coronary revascularization2. After a median follow-up of almost two years, there was a significant reduction of 48% in the incidence of the primary endpoint for patients in whom colchicine was started <day 3 compared to placebo (HR=0.52, 95% CI 0.32-0.84)1. The beneficial effects of starting early colchicine treatment were also demonstrated for urgent hospitalization for angina requiring revascularization (HR=0.35), all coronary revascularization (HR=0.63) and the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction or stroke (HR=0.55, all p<0.05), with reductions of 65%, 37% and 45% respectively1.
“Colchicine is a remarkably cost-effective and well-tolerated medication with anti-inflammatory and immunomodulatory properties,” 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 and COLCORONA primary investigator. “These new data not only support the benefits of colchicine in patients with coronary disease but strengthen our belief that the drug may also be a significant asset in the global fight against COVID-19 by reducing inflammatory storms in patients with the disease, preventing hospitalizations and even deaths.”
Additional pharmacogenetic data from COLCOT, also presented during the ESC virtual late-breaking session today, examined the role of genetic markers in identifying patients that may benefit from colchicine treatment following an MI3. Considering that patients receive long-term treatment with multiple drugs after a heart attack, prediction of those unlikely to benefit from a specific medication is necessary to decrease polypharmacy. These data show that there are credible genetic variants associated with cardiovascular endpoints and gastrointestinal disorder in patients treated with colchicine and that some patients might achieve a better response, with the potential for a more personalized approach to inflammation reduction for cardiovascular prevention3.
Colchicine, a potential drug to fight COVID-19
In addition to these meaningful results from COLCOT, colchicine is also being evaluated in the COLCORONA clinical trial. This multi-center, contact-less, at home study aims to determine the therapeutic benefit of colchicine as a treatment to prevent complications and death related to COVID-19. COLCORONA is one of the few current studies of COVID-19 infection in which non-hospitalized individuals can participate.
The significance of the COLCOT data and treatment with colchicine following a myocardial infarction has now been highlighted in four late-breaking science sessions at the AHA, ACC and ESC respectively over the last 10 months1,2,3,4. These data show that not only is colchicine significantly effective in reducing the risk of first and total ischemic cardiovascular events by 23% and 34% respectively overall, but that adding colchicine 0.5mg daily to standard of care therapy following a myocardial infarction is economically dominant and may help generate significant cost-savings for healthcare systems1,2,4.
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, published in the New England Journal of Medicine, 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 countries2.
About the COLCORONA Trial
COLCORONA is a randomized, double-blind, placebo-controlled clinical trial. It was initiated by Dr. Jean-Claude Tardif, Director of the MHI Research Center and Professor of Medicine at the University of Montreal and aims to determine if colchicine may prevent the phenomenon of major inflammatory storm observed in adults suffering from serious complications linked to COVID-19. The clinical trial requires the recruitment of 6000 patients who meet all the inclusion criteria and none of the exclusion criteria. Patients are randomly assigned to either colchicine or a placebo for 30 days. Evaluations by phone or videoconference then take place 15 and 30 days after the randomization. The study is monitored by a data monitoring committee (DMC) that includes experienced clinical researchers.
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 the largest cardiovascular genetics center in Canada. 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.
- Bouabdallaoui N, Tardif J-C, Walters D, et al. Time-to-treat initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT). Eur Heart J: Available at https://academic.oup.com/eurheartj/issue
- Tardif J-C, Kouz S, Waters D, et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019; 381:2497-2505 DOI: 10.1056/NEJMoa1912388
- Dube M-P, Legault M-A, Lemacon A, et al. Pharmacogenomics of the Efficacy and Safety of Colchicine in COLCOT. Presented by Dr. Dube at the virtual European Society of Cardiology Annual Scientific Sessions (ESC 2020), August 31, 2020.
- Samuel M, Tardif J-C, 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 May 14;qcaa045. doi: 10.1093/ehjqcco/qcaa045.
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SOURCE Montreal Heart Institute