Fosfomycin Trometamol versus Comparator Antibiotics for the Treatment of Acute Uncomplicated Urinary Tract Infections in Women: A Systematic Review and Meta-Analysis.

PURPOSE: We performed a systematic review and meta-analysis to compare the effectiveness and safety profile of fosfomycin vs comparator antibiotics in women with acute uncomplicated cystitis. MATERIALS AND METHODS: Relevant databases were searched using methods recommended by the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. We assessed the risk of bias and confounders. The study primary end point was clinical or microbiological success, defined as complete (cure) and/or incomplete resolution of symptoms at the end of treatment (improvement) and/or microbiological eradication. RESULTS: After screening 539 articles 15 were included which recruited a total of 2,295 adult female patients. Of the studies 14 were used for microbiological eradication analysis. We used 11 of the 15 articles in a total of 1,976 patients for clinical resolution and 11 in a total of 1,816 patients for safety outcome analysis. No difference was found for clinical resolution in all comparators combined in 11 randomized controlled trials in a total of 1,976 patients (OR 1.16, 95% CI 0.91-1.49, p=0.13). No difference was found for microbiological eradication in 14 randomized controlled trials in a total of 2,052 patients (OR 1.03, 95% CI 0.83-1.30, p=0.09) or for safety outcome in 11 randomized controlled trials in a total of 1,816 patients (OR 1.17, 95% CI 0.86-1.58, p=0.33). Most adverse effects reported for fosfomycin were transient and single dose therapy seems to have resulted in better patient compliance. CONCLUSIONS: Single dose oral fosfomycin trometamol is equal to comparator regimens in terms of clinical and microbiological effectiveness and safety in women with microbiologically confirmed and/or clinically suspected, acute uncomplicated cystitis. It is associated with high patient compliance.