Oteseconazole for acute and recurrent vulvovaginal candidiasis: A systematic review, meta-analysis, and trial sequential analysis of randomized trials
Abstract
ObjectivesVulvovaginal candidiasis and its recurrent vulvovaginal candidiasis form place a significant burden on women worldwide. However, treatment options remain limited. Oteseconazole, a first-in-class tetrazole CYP51 inhibitor that received Food and Drug Administration approval for recurrent vulvovaginal candidiasis in 2022, has not yet had its comparative efficacy against fluconazole in acute vulvovaginal candidiasis systematically synthesized. In addition, the full scope of evidence for its maintenance use has not been formally synthesized. Using a dual-Population-Intervention-Comparator-Outcome (PICO) framework, this systematic review and meta-analysis aimed to: (a) evaluate whether oteseconazole provides superior efficacy to fluconazole in acute vulvovaginal candidiasis; (b) comprehensively synthesize maintenance efficacy and safety outcomes in recurrent vulvovaginal candidiasis; and (c) assess the certainty and sufficiency of the available evidence using Grading of Recommendations Assessment, Development, and Evaluation and trial sequential analysis.MethodsThis systematic review and meta-analysis was prospectively registered with PROSPERO (registration number: CRD420261331936). A systematic search of PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov was conducted without date or language restrictions. Risk of bias was assessed using the Cochrane Risk of Bias 2.0 tool. Meta-analyses were performed using random-effects models with restricted maximum likelihood…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 959 participants or records.
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