Colchicine and the risk of major adverse cardiovascular events in patients with gout and Type 2 diabetes: A nationwide cohort study

Abstract Background Type 2 diabetes mellitus (T2DM) and gout are associated with an increased risk of cardiovascular events. Despite the approval for the secondary prevention of cardiovascular diseases by the United States Food and Drug Administration in 2023, evidence regarding the effectiveness of colchicine among T2DM population remains limited. Objectives We aimed to evaluate the association between the use of colchicine and the risk of major adverse cardiovascular events (MACE) among patients with gout and T2DM. Methods We conducted a nationwide, population‐based cohort study with active comparator, new‐user design using nationwide claims data of South Korea (2010–2022). Patients with T2DM and gout who initiated colchicine or non‐steroidal anti‐inflammatory drugs (NSAIDs) from 2011 to 2022 were included. The primary outcome was MACE (myocardial infarction, ischemic stroke, and cardiovascular death). Secondary outcomes were each individual components of primary outcome and hospitalization due to heart failure. As‐treated approach with 30‐day grace period was applied. Results Before propensity score (PS) matching, 13,019 colchicine users and 111,594 NSAIDs users were included in the study cohort (mean age, 65.5 vs. 62.9; 35.0% vs. 29.8% female). After 1:2 PS matching, 12,908 colchicine users and 25,816 NSAIDs users remained (mean age, 65.7 vs. 65.7 years; 35.2% vs. 35.1% female). The PS‐matched hazard ratio for MACE was 0.94 (95% confidence interval 0.65–1.36), and all secondary outcomes also resulted in null findings. Conclusions Use of colchicine does not significantly reduce the risk of MACE compared with NSAIDs in a real‐world population with T2DM and gout in South Korea between 2011 and 2022.