Safety and efficacy of Simvastatin in the treatment of vitiligo: a systematic review and meta-analysis of randomized controlled trials

Abstract

Vitiligo is an autoimmune skin disorder characterized by progressive depigmentation due to melanocyte destruction. Despite various treatment options, achieving complete repigmentation remains challenging. Simvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, has demonstrated anti-inflammatory and immunomodulatory effects, making it a promising candidate for vitiligo treatment. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of Simvastatin in vitiligo treatment. A systematic search of PubMed, Scopus, Web of Science, and Cochrane Library was conducted following PRISMA guidelines. Only RCTs comparing Simvastatin with a control or pre-post Simvastatin assessments in vitiligo patients were included. Six RCTs with a total of 371 patients met the eligibility criteria. The primary outcomes analyzed were VASI reduction and excellent repigmentation response (≥ 75% repigmentation). Secondary outcomes included changes in total cholesterol, triglycerides, and low-density lipoprotein (LDL) levels. Meta-analyses were performed using a random-effects model, and heterogeneity was assessed using the I² statistic. Simvastatin significantly reduced VASI scores (SMD = −0.30; 95% CI −0.52–−0.07, p = 0.010; I² = 0%). The likelihood of achieving excellent repigmentation (≥ 75%) was significantly higher in the Simvastatin group (OR = 6.54; 95% CI 1.08–38.42, p = 0.04; I² = 0%). Additionally, Simvastatin led to a significant reduction in total cholesterol (−62.1 mg/dL; 95% CI −74.0–−50.2, p < 0.00001; I² = 0%), triglycerides (−65.08 mg/dL; 95% CI −89.81–−40.35, p < 0.00001; I² = 69%), and LDL (−66.13 mg/dL; 95% CI −77.50–−54.76, p < 0.00001; I² = 90%). Simvastatin demonstrates significant efficacy in vitiligo treatment, improving VASI scores and repigmentation while also lowering lipid levels. This is the first meta-analysis on this topic, providing evidence for Simvastatin as a potential adjunct therapy. Further large-scale RCTs are needed to validate these findings.