Low-Dose Colchicine in Patients With Type 2 Diabetes and Recent Myocardial Infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT).
Level 2 - randomized trial
Prespecified subgroup analysis of a double-blind randomized controlled trial
PubMed 38181203 · doi:10.2337/dc23-1825
What was done
This was a prespecified subgroup analysis of the randomized, double-blind Colchicine Cardiovascular Outcomes Trial (COLCOT). The study evaluated 959 patients with type 2 diabetes who were initiated on colchicine 0.5 mg daily or placebo within 30 days after a myocardial infarction and monitored for a median of 22.6 months.
What was found
A primary end point event occurred in 8.7% of patients in the colchicine group compared to 13.1% in the placebo group (hazard ratio 0.65; 95% CI 0.44-0.96; P = 0.03). For adverse events, nausea was reported in 2.7% of colchicine patients versus 0.8% of placebo patients (P = 0.03), and pneumonia occurred in 2.4% versus 0.4% (P = 0.008).
Why it matters
This study provides randomized evidence that anti-inflammatory therapy with low-dose colchicine leads to a large reduction in recurrent cardiovascular events among high-risk patients with type 2 diabetes and recent myocardial infarction.
Limits
As a subgroup analysis, the sample size and absolute event counts are smaller than the main trial, increasing susceptibility to imprecision. Specific components of the primary composite endpoint, baseline glycemic control, and long-term safety beyond median follow-up are not detailed in the abstract. Colchicine was associated with statistically significant increases in pneumonia and nausea.