OBJECTIVE: The cardiovascular benefits of low-dose colchicine have been demonstrated in patients with coronary disease. Its effects were evaluated in this prespecified analysis in patients with type 2 diabetes (T2D) from the Colchicine Cardiovascular Outcomes Trial (COLCOT).
RESEARCH DESIGN AND METHODS: COLCOT was a randomized, double-blinded trial of colchicine, 0.5 mg daily, versus placebo initiated within 30 days after a myocardial infarction.
RESULTS: There were 959 patients with T2D enrolled and monitored for a median of 22.6 months. A primary end point event occurred in 8.7% of patients in the colchicine group and in 13.1% in the placebo group (hazard ratio 0.65; 95% CI 0.44-0.96; P = 0.03). Nausea was reported in 2.7% and 0.8% in the study groups (P = 0.03), and pneumonia occurred in 2.4% and 0.4% (P = 0.008).
CONCLUSIONS: Among patients with T2D and a recent myocardial infarction, colchicine, 0.5 mg daily, leads to a large reduction of cardiovascular events. These results support the conduct of the COLCOT-T2D trial in primary prevention.
Amazing!! Should be read widely.
Although the results from the main trial were compelling, the findings from this subgroup analysis of patients with type 2 diabetes were similar to the main trial results. This is hardly surprising, as one would not expect a different effect of this medication in patients with diabetes who have had an MI.
Based on the two landmark trials, low-dose colchicine has recently been recommended by leading cardiovascular societies (such as ESC and ACC) as a secondary prevention of CVD, particularly among individuals with severe or uncontrolled risk factors, including diabetes. This study is a prespecified subgroup analysis of the landmark trial from 2019 using colchicine after MI to reduce MACE events. It confirmed that using low-dose colchicine in patients with T2D or prediabetes reduces multiple cardiovascular and cerebrovascular endpoints following MI, with a risk reduction of 35% during the median follow-up of 22.6 months. This sheds light on the additional treatment modalities in these populations with uncontrolled risk factors despite optimal medical therapy. Noteworthy, despite proven benefits, this therapy is not fostered enough by the pharmaceutical industry for this indication, presumably because colchicine is an old and not profitable medication.
The findings confirm what we learnt from the COLCOT trial and show that, in people with diabetes, the benefits of colchicine are even greater.
A subgroup analysis of the COLCOT trial in patients with T2DM showing improved CVD outcomes with long-term use of colchicine. This is of interest to both primary care physicians and cardiologists.
I’m not sure this adds anything to the main trial results. Why would the authors expect something less in this subgroup? The usual rule of thumb is the higher the risk, the greater the benefit of an intervention. Patients with DM are at higher risk, so these results confirm only what should have been the a priori expectation for this subgroup. I'm not enthusiastic and I’m not sure it really matters whether or not my primary care physician colleagues know the results of this study.
Although this is a secondary analysis, it was pre-specified and has an interesting finding worthy of discussion. Many providers are probably not aware of the potential role of colchicine in this population.
Nothing to lose here: inexpensive, safe, and the side effects at this dose are rather small.