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

ABSTRACT

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 < 0·001). Among ulcers > 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 < 0·001) post-treatment. No adverse effects were documented. CONCLUSIONS: Simvastatin 40 mg daily, in addition to standard wound care and compression, is associated with a significant improvement in healing rate and time, as well as an improved patient quality of life when compared with placebo in the management of venous ulcers.