Colchicine reduces arterial stiffness in high-risk T2D patients: RCT

AIMS: The anti-inflammatory drug colchicine has been shown to reduce the risk of cardiovascular disease (CVD) in patients with and without diabetes. The underlying mechanisms are, however, elusive. In this trial, we investigated the effect of colchicine on arterial stiffness, ambulatory blood pressure, and albuminuria in patients with type 2 diabetes. METHODS AND RESULTS: We conducted a double-blind, randomized, placebo-controlled trial in individuals with type 2 diabetes with a history of CVD or a high risk thereof. One hundred participants were assigned in a 1:1 ratio to receive colchicine 0.5 mg once daily or placebo for 26 weeks. The primary outcome was change in arterial stiffness assessed as carotid-femoral pulse wave velocity (cfPWV). Secondary outcomes included 24-h ambulatory BP and urine albumin-to-creatinine ratio (UACR). Treatment with colchicine significantly mitigated arterial stiffness progression compared with placebo [mean arterial pressure (MAP)-adjusted change in cfPWV: -0.7 m/s, 95% CI: -1.3; -0.1, P = 0.03]. Crude analyses without MAP adjustment showed a non-significant reduction in cfPWV of -0.3 m/s (95% CI: -1.0; 0.4, P = 0.45). Colchicine had no significant effect on 24-h systolic ambulatory BP (change: 3.0 mmHg, 95% CI: -0.5; 6.5 mmHg, P = 0.10) or UACR (percentage change: 0.5, 95% CI: -29.5; 40.4, P = 0.98). CONCLUSION: This study suggests that low-dose colchicine may reduce arterial stiffness in high risk patients with type 2 diabetes. While these findings indicate that mitigating arterial stiffness contributes to the observed reduction in cardiovascular events in outcome trials, further research is needed to confirm these effects and understand the underlying mechanisms. Clinical trial registration information: EudraCT-no.: 2021-003525-30.Link: https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003525-30/DK.