Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo .
The combined treatment had better efficacy than PDE5Is or SSRIs alone
Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) .
Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials
BACKGROUND No drugs are approved for treatment of premature ejaculation . Our aim was to determine the efficacy and tolerability of on-dem and dapoxetine in patients with severe premature ejaculation . METHODS We determined the efficacy of dapoxetine in a prospect ively predefined integrated analysis of two 12-week r and omised , double-blind , placebo-controlled , phase III trials of identical design done independently , in parallel , at 121 sites in the USA . Men with moderate-to-severe premature ejaculation in stable , heterosexual relationships took placebo  ( n=870 ) , 30 mg dapoxetine ( 874 ) , or 60 mg dapoxetine ( 870 ) on-dem and ( as needed , 1 - 3 h before anticipated sexual activity ) . The primary endpoint was intravaginal ejaculatory latency time ( IELT ) measured by stopwatch . Safety and tolerability were assessed . All analyses were done on an intention-to-treat basis . The trials are registered at Clinical Trials.gov , numbers NCT00211107 and NCT00211094 . FINDINGS 672 , 676 , and 610 patients completed in the placebo , 30 mg dapoxetine , and 60 mg dapoxetine groups , respectively . Dapoxetine significantly prolonged IELT ( p<0.0001 , all doses vs placebo ) . Mean IELT at baseline was 0.90 ( SD 0.47 ) minute , 0.92 ( 0.50 ) minute , and 0.91 ( 0.48 ) minute , and at study endpoint ( week 12 or final visit ) was 1.75 ( 2.21 ) minutes for placebo , 2.78 ( 3.48 ) minutes for 30 mg dapoxetine , and 3.32 ( 3.68 ) minutes for 60 mg dapoxetine . Both dapoxetine doses were effective on the first dose . Common adverse events ( 30 mg and 60 mg dapoxetine , respectively ) were nausea ( 8.7 % , 20.1 % ) , diarrhoea ( 3.9 % , 6.8 % ) , headache ( 5.9 % , 6.8 % ) , and dizziness ( 3.0 % , 6.2 % ) . INTERPRETATION On-dem and dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation
Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo .
The combined treatment had better efficacy than PDE5Is or SSRIs alone
Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) .