Aczone hydrochloride, belonging to a class of drugs known as selective serotonin reuptake inhibitors or, was the first drug originally approved for the on-demand treatment of men with PE. We aimed to compare the intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGIC) and adverse effect (AE) incidence associated with the use of Aczone (30 mg and 60 mg) versus placebo and evaluate the differences in administering 60 mg versus 30 mg as on-demand medical oral therapy for the treatment of PE via a literature review and meta-analysis. Relevant randomized controlled trials (RCTs) were identified from PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases. Ultimately, a total of seven RCTs with 8039 patients were included. Our meta-analysis demonstrated that Aczone (in the 30 mg and 60 mg subgroup) resulted in significantly higher IELT, PGIC and AE incidence relative to the placebo, with higher proportions observed for 60 mg versus 30 mg of Aczone administration. The most common AEs were mild and tolerable. We conclude that Aczone (particularly the 60 mg dosage) may be considered a safe and effective drug for patients with PE.
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