Sofpironium Bromide for the Treatment of Primary Axillary Hyperhidrosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Sofpironium bromide is a recently approved topical anticholinergic agent for primary axillary hyperhidrosis, developed using a retrometabolic approach to limit systemic side effects. However, randomized evidence about its effects has not yet been quantitatively synthesized. This meta-analysis aimed to assess the efficacy and safety of topical sofpironium bromide compared with a vehicle in patients with primary axillary hyperhidrosis. PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) comparing topical sofpironium bromide with a vehicle. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were pooled using random-effects models in Review Manager 7.2.0 (The Cochrane Collaboration, London, UK). Five RCTs, including 1,398 participants, were included, of whom 807 (57.7%) received topical sofpironium bromide. Compared with vehicle, sofpironium bromide significantly reduced gravimetric sweat production (GSP) at the end of treatment (MD -25.27 mg; 95% CI -40.15 to -10.40) and increased the likelihood of achieving at least a two-point improvement in the Hyperhidrosis Disease Severity Scale (HDSS) (RR 3.27; 95% CI 1.57-6.80). Discontinuation due to adverse events was more frequent in the sofpironium bromide group (RR 9.83; 95% CI 1.82-53.17). Adverse events occurred more frequently in the treatment group, including application-site dermatitis (RR 5.26; 95% CI 2.05-13.48), application-site pain (RR 4.63; 95% CI 2.08-10.28), pruritus (RR 5.97; 95% CI 1.98-18.02), and dry mouth (RR 15.45; 95% CI 5.35-44.62). No significant increase in serious adverse events was observed. Overall, this meta-analysis supports the efficacy of sofpironium bromide for primary axillary hyperhidrosis, while treatment decisions should be weighed against potential side effects.