Simvastatin as a novel therapeutic agent for venous ulcers: a randomized, double-blind, placebo-controlled trial

Summary Background Although the standard treatment for venous ulcers is compression, drugs may be used as adjunctive therapy. Simvastatin has shown potential wound‐healing properties; however, no studies have investigated its use in venous ulcers. Objectives To assess the efficacy and safety of simvastatin in venous ulcer healing when combined with standard treatment for ulcers. Methods This was a randomized, double‐blind, placebo‐controlled trial. Outcome measures were the proportion of healed ulcers, healing time, total surface area healed and Dermatology Life Quality Index (DLQI) scores. Results Sixty‐six patients were randomized into two groups: a simvastatin (n = 32) and a control (n = 34) group. Among ulcers ≤ 5 cm, 100% were healed in the simvastatin group, and 50% were healed in the control group [relative risk (RR) 0·10, 95% confidence interval (CI) 0·0141–0·707]. The average healing times for ulcers ≤ 5 cm were 6·89 ± 0·78 weeks and 8·40 ± 1·13 weeks for the simvastatin and control groups, respectively (P 5 cm, 67% closed in the simvastatin group, with a mean healing time of 9·17 ± 1·07 weeks. No ulcers of this size closed in the control group (RR 0·33, 95% CI 0·132–0·840). The simvastatin group had lower DLQI scores (P