The use of colchicine did not significantly reduce the risk of major adverse cardiovascular events (MACE) compared with non-steroidal anti-inflammatory drugs (NSAIDs) in a real-world population study of people with type 2 diabetes mellitus (T2D) and gout.1
“Given the scarcity of evidence from those with both T2D and gout and the different results observed in clinical trials, further research among those population is warranted on the cardiovascular effectiveness of colchicine. To bridge these research gaps, we aimed to investigate the association between colchicine use and the risk of MACE among patients with T2D and gout by conducting a population-based cohort study using the nationwide claims data from South Korea,” study investigator Minjeong Jeon, School of Pharmacy, Sungkyunkwan University, Suwon, South Korea, and colleagues wrote.1
Jeon and colleagues conducted a nationwide, population-based cohort study with an active comparator, new-user design using nationwide claims data from South Korea between 2010 and 2022. The study included people with T2D and gout who initiated colchicine or NSAIDS between 2011 to 2022. The study primarily evaluated MACE events which included myocardial infarction, ischemic stroke, and cardiovascular death. The investigators also assessed each individual MACE component and hospitalization due to heart failure as secondary outcomes. They applied an as-treated approach with a 30-day grace period to the study data.
Overall, the study included 13,019 people using colchicine and 111,594 using NSAIDS. Participants had mean ages of 65.5 and 62.9, respectively, and consisted of 35.0% female and 29.8% female participants, respectively. After 1:2 propensity score matching, the study compared 12,908 in the colchicine group and 25,816 in the NSAIDs group (mean age, 65.7 vs. 65.7 years; 35.2% vs. 35.1% female).
Jeon and colleagues found that the propensity score-matched hazard ratio for MACE was an insignificant 0.94 (95% CI, 0.65–1.36) for the colchicine group. Furthermore, all secondary outcomes assessed also resulted in similar, insignificant findings, demonstrating no significant differences between groups in MACE risk.
“This nationwide, population-based cohort study conducted from 2011 to 2022 found that colchicine use does not significantly reduce the risk of MACE in a real-world population from South Korea with T2D and gout. The findings from this study implies that cardiovascular risk may not be a main consideration in colchicine prescription for gout in patients with T2D,” Jeon and colleagues concluded.1
Other research into MACE event risk with colchicine in people with chronic cardiovascular disease or acute coronary syndrome was recently published by Sining Xie, Epidemiology and Preventive Pharmacology Service, Department of Pharmacological and Biomolecular Sciences, University of Milan, Italy, and colleagues and did demonstrate a reduction in MACE risk when low-dose colchicine was added to standard care for at least 12 months2
Xie and colleagues analyzed data from 6 randomized controlled trials including 21,774 participants. They found that colchicine significantly reduced the risk of MACEs (risk ratio [RR], 0.74; 95% CI, 0.60–0.92) as well as specifically myocardial infarction (RR, 0.85; 95% CI, 0.73–0.98) and stroke (RR, 0.79; 95% CI, 0.65–0.95), with no significant effect on cardiac death and revascularization.2
“The evidence from this study further supports the use of colchicine in patients with stable atherosclerotic disease as an add-on to standard therapies, as already highlighted by FDA recommendations and the recent guidelines of the European Society of Cardiology. Limited data on long-term safety and optimal inflammatory modulation with colchicine warrant further investigation, and future studies should explore more targeted anti-inflammatory therapies that could potentially offer greater efficacy and improved tolerability,” Xie and colleagues concluded.2
References
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Jeon M, Cho Y, Bea S, et al. Colchicine and the risk of major adverse cardiovascular events in patients with gout and Type 2 diabetes: A nationwide cohort study. Journal of Internal Medicine. Published online August 23, 2025. doi: 10.1111/joim.70012
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Xie S, Galimberti F, Olmastroni E, Catapano AL, Casula M. Colchicine and cardiovascular events: An updated meta‐analysis of published randomized controlled trials. Journal of Internal Medicine. Published online July 7, 2025. doi: 10.1111/joim.20107