A benefit-risk assessment of dapoxetine in the treatment of premature ejaculation.

Premature ejaculation (PE) is considered to be the most common sexual problem affecting men, despite the likelihood that it is under-diagnosed. It is a complex condition with many physical and psychological components, making management complicated. It is important to develop treatments for PE as it adversely affects quality of life for individuals and partners. Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) that has been developed principally for the treatment of PE. It is considered more suitable for the treatment of PE than other SSRIs as it can be used as an 'on demand' treatment to be taken a few hours before an expected sexual encounter, reducing the possibility of adverse effects. Dapoxetine may represent a breakthrough in the treatment of PE as it is the first drug to be licensed for this indication. This review attempts to present a balanced benefit-risk assessment of dapoxetine by examining the evidence from phase III clinical trials, focusing on its efficacy in prolonging intravaginal ejaculatory latency time (IELT), patient sexual satisfaction and safety in patients with PE. The benefits and risks of other therapies that are used to treat PE off-licence are also reviewed. There has only been one study to date that directly compares dapoxetine to another therapy, paroxetine, for this indication. It was found that dapoxetine is most effective at a dose of 60 mg in increasing IELT compared with placebo. All studies have also found that dapoxetine is well tolerated as an 'on-demand' therapy and with continual dosing; however, there are little data regarding possible long-term adverse effects. Findings of the dapoxetine development programme demonstrated that dapoxetine is associated with vasovagal-mediated (neurocardiogenic) syncope. No other associated significant cardiovascular adverse events were identified. Further research is needed to directly compare dapoxetine with other therapies and to investigate the outcomes of dapoxetine used in conjunction with behavioural therapies, and other non-pharmaceutical therapies.