2023-06-27 04:54:32
A study led by a Quebec researcher has led the Food and Drug Administration (FDA) to approve, for the first time, an anti-inflammatory that can prevent cardiovascular events.
Updated yesterday at 5:00 a.m.
What there is to know
The Quebec COLCOT study led to FDA approval of the first anti-inflammatory for the prevention of cardiovascular events. According to the results of COLCOT, colchicine reduces cardiovascular events by 23% in patients who have suffered a heart attack in the 30 days preceding the administration of the drug. In Quebec, you can get colchicine for less than $1 a day. The side effects of colchicine are mainly gastrointestinal.
The US FDA last week approved low-dose colchicine (0.5 milligrams per day) to reduce the risk of heart attack, stroke, coronary artery bypass and cardiovascular death in patients with coronary heart disease or who have multiple cardiovascular risk factors.
“This is very good news, we are very proud! “Launches the director of the research center of the Montreal Heart Institute and professor of medicine at the University of Montreal Jean-Claude Tardif, joined by telephone.
Dr. Tardif conducted the first of two studies that led the FDA to approve the anti-inflammatory in the prevention of cardiovascular events. The COLCOT study, published in 2019 in the journal The New England Journal of Medicine, compared the effectiveness of colchicine and a placebo in reducing cardiovascular risk in 4745 patients. The results demonstrate that colchicine reduces cardiovascular events by 23% in patients who have suffered a heart attack within 30 days prior to drug administration.
The COLCOT results were supported by a second study in 2020, LoDoCo-2, also published in The New England Journal of Medicine and conducted by Australian researcher and cardiologist Stefan Mark Nidorf. Researchers report a 31% reduction in the risk of cardiovascular events with colchicine in patients with chronic cardiovascular disease when added to standard preventive treatments.
COLCOT led to the approval of colchicine by Health Canada in 2021 for the reduction of cardiovascular events in patients with cardiovascular disease.
For Dr. Tardif, the approval of colchicine by the FDA must now translate into action. “Now that this drug has been approved by the most stringent agencies, doctors and nurses need to be informed and reassured to promote its prescription,” he explains.
Benefits that outweigh the risks
Who says medicine, says side effects. Colchicine is no exception to the rule. The symptoms reported by the COLCOT and LoDoCo-2 studies are mainly gastrointestinal. The researchers noted stomach aches, diarrhea and vomiting. Muscle pain has also been observed.
PHOTO PROVIDED BY THE MONTREAL HEART INSTITUTE
Dr. Jean-Claude Tardif
Overall, colchicine was well tolerated in the patients who participated in the study. But it is not recommended for people with kidney failure or severe liver disease.
Dr. Jean-Claude Tardif
The researcher and director of the cardiology research axis at the Institut universitaire de cardiologie et de pneumologie de Québec, Philippe Pibarot, who was not involved in the studies, is also delighted with the approval of colchicine by the FDA. , especially since this important advance can be partly attributed to a homegrown study.
According to Dr. Pibarot, what distinguishes colchicine from other anti-inflammatories is the safety associated with its chronic use.
There are other anti-inflammatories that are stronger than colchicine, but they also come with more side effects. In the case of colchicine, its effectiveness outweighs its side effects.
Dr Philippe Pibarot
Its low cost is also an attractive factor for patients. “In Quebec, you can get it for less than $1 a day,” points out Dr. Tardif.
The many facets of colchicine
The use of colchicine as an anti-inflammatory is not new. Far from there. “Colchicine comes from a plant, fall colchicum, which was consumed thousands of years ago for its anti-inflammatory properties,” explains Dr. Tardif.
Colchicine was later marketed to treat gout, pericarditis, and familial Mediterranean fever.
What prompted Dr. Tardif to test its effectiveness once morest cardiovascular disease? “It’s been known for regarding 20 years that inflammation is a major cause of atherosclerosis, the buildup of fat in the arteries that can lead to heart attacks,” he explains. We therefore wanted to assess whether the anti-inflammatory power of colchicine might prevent cardiovascular events. »
The next step ? To test the preventive power of this drug in patients who have never had a cardiac event, but who present certain risk factors. Dr. Tardif’s team is also recruiting people who suffer from type II diabetes in order to launch the next phase of its research.
Colchicine found itself at the heart of a media storm at the start of 2021, when preliminary results obtained by Dr. Tardif’s team seemed to demonstrate its effectiveness in preventing complications related to COVID-19.
The National Institute of Excellence in Health and Social Services of Quebec (INESSS), which reviewed the study, concluded that these results were not statistically significant and that further research were needed.
According to Dr. Pibarot, on the contrary, the results of the COLCOT study are very robust, especially since they have been supported by several clinical trials.
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