COLCOT: Colchicine beneficial in patients with diabetes, recent MI
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Patients with diabetes and recent MI had reduced risk for first and total CV events with colchicine compared with placebo, according to new data from the COLCOT trial.
As Healio previously reported, in the main results of COLCOT, adults with a recent MI assigned colchicine, an anti-inflammatory medication used to treat gout, had 23% reduced risk for first CV events and 34% reduced risk for total CV events at 2 years compared with those assigned placebo. François Roubille, MD, PhD, head of the ICU at University Hospital of Montpellier, France, presented an analysis of the patients with diabetes from COLCOT at the virtual American Heart Association Scientific Sessions.
“Experimental and clinical evidence have shown the role of inflammation in atherosclerosis,” Roubille said during a presentation. “The effects of low-dose colchicine were evaluated in the COLCOT patients with diabetes, as the latter is a pro-inflammatory state.”
The analysis included 959 patients (mean age, 62 years; 22% women) who were assigned colchicine 0.5 mg once daily or placebo.
Overall, patients with diabetes were more likely to achieve the primary endpoint of first ischemic event, defined as CV death, resuscitated cardiac arrest, MI, stroke or hospitalization for angina leading to coronary revascularization at 2 years, than those without diabetes (adjusted HR = 1.86; 95% CI, 1.45-2.39; P < .0001), Roubille said.
Among those with diabetes, the primary efficacy endpoint was reduced by 35% in the colchicine group compared with the placebo group (aHR = 0.65; 95% CI, 0.44-0.96; P = .03), he said.
Total ischemic events over 2 years were also reduced in the colchicine group compared with the placebo group (colchicine group, 0.48 events per 100 patient-months; placebo group, 0.96 events per 100 patient-months; HR by negative binomial model = 0.53; 95% CI, 0.33-0.87), according to the researchers.
There was no difference between the groups in total or serious adverse events, although the colchicine group had a higher rate of pneumonia (2.4% vs. 0.4%; P = .008), Roubille said.
“Colchicine at 0.5 mg per day significantly reduces the risk of first and total cardiovascular events by 35% and 47%, respectively, in patients with diabetes and a recent myocardial infarction,” Roubille said during the presentation. “The COLCOT trial and the LoDoCo2 trial have confirmed the beneficial effects of colchicine in secondary prevention. We think that the next step could be investigating the drug in primary prevention, and we are about to launch a large trial in primary prevention named the COLCOT-T2D trial with more than 10,000 patients with type 2 diabetes but without known coronary disease.”
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Roubille F, et al. FS.04: High profile clinical science in CVD. Presented at: American Heart Association Scientific Sessions; Nov. 13-17, 2020 (virtual meeting).
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