Efficacy and safety of daily low-dose colchicine after recent MI
Background: Clinical evidence supports the role of inflammation in atherosclerosis and its complications. Colchicine (Colcrys) in an orally administered potent anti-inflammatory that is currently used to treat gout and pericarditis.
Dr. Sameer Qazi
Study design: Randomized, double-blind, placebo-controlled, investigator-initiated trial.
Setting: Funded by Canadian Institute of Health and Research, 167 centers in 12 different countries. Centers were predominately located in Canada, South America, and Europe.
Synopsis: In this study, 4,745 patients with a MI within the last 30 days and treated according to national guidelines were enrolled. There were multiple exclusion criteria including severe heart, renal, and/or hepatic failure. The mean age of patients was 60.6 years. Patients were followed for a median of 22.6 months. The primary endpoint was a composite of death from cardiovascular causes, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization.
The primary endpoint occurred in 5.5% of patients in the colchicine group and 7.1% of those in the placebo group (hazard ratio, 0.77). This was largely because of a decreased incidence of stroke in the colchicine group compared to placebo (0.2% vs 0.8%) and decreased urgent hospitalizations for unstable angina leading to revascularization (1.1% vs 2.1%).
Nausea was more common in the colchicine group as well as pneumonia which was reported as a serious adverse event (0.9% compared to 0.4% in placebo).
Limitations included short follow-up and significant exclusion criteria.
Bottom line: In patients following a recent myocardial infraction, the use of low-dose colchicine at 0.5 mg daily led to a significantly lower percentage of ischemic cardiovascular events compared to placebo.
Citation: Tardif JC et al. Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med. 2019 Dec 26;381:2497-505.
Dr. Qazi is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
