Colchicine mitigates arterial stiffness in high-risk patients with type 2 diabetes: A randomized placebo-controlled trial

Abstract Aims The anti-inflammatory drug colchicine has been shown to reduce the risk of cardiovascular disease 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 We conducted a double-blind, randomized, placebo-controlled trial in individuals with type 2 diabetes with a history of cardiovascular disease or a high risk hereof. 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-hour ambulatory BP and urine albumin-to-creatinine ratio (UACR). Results Treatment with colchicine significantly mitigated arterial stiffness progression compared to 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-hour 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 contribute to the observed reduction in cardiovascular events in outcome trials, further research is needed to confirm these effects and understand the underlying mechanisms.