Grant: Project Grant

Inflammation appears to play an important role in atherosclerosis. Colchicine is an anti-inflammatory medication and is one of the oldest remedies still in use today as a treatment for gout and for Familial Mediterranean Fever. Recently, we have shown in the COLCOT-1 study (COLchicine Cardiovascular Outcomes Trial) that a low dose of colchicine reduced the risk of cardiovascular events in patients with a recent heart attack. Patients using colchicine had 23% fewer events compared to those receiving an inactive substance (placebo) in a study including 4745 patients with a recent heart attack. We now want to study the possible benefits of colchicine in other high-risk patients, such as those with diabetes. The primary objective of the new COLCOT-T2D study is to determine if long-term treatment with colchicine will reduce major cardiovascular events in patients with diabetes. We will also assess the effects of colchicine on the development and progression of cognitive impairment. Additionally, cost-effectiveness and quality of life will be assessed. COLCOT-T2D is a study comparing colchicine 0.5 mg/day and placebo in 10,000 patients aged 60 years and up with type 2 diabetes and at least one additional cardiovascular risk factor. The main criterion of efficacy will be the development of unfavorable events such as death, heart attack, stroke or urgent hospitalization for angina requiring invasive intervention. Cognitive function will also be evaluated. The study will be overseen by an independent monitoring committee. We hope to demonstrate that low-dose colchicine safely reduces the risk of cardiovascular events in patients with diabetes who were initially not known to suffer from heart disease.