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 safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study.
INTRODUCTION Men with comorbid erectile dysfunction ( ED ) and premature ejaculation ( PE ) may be concomitantly prescribed a phosphodiesterase type 5 ( PDE5 ) inhibitor and dapoxetine . AIM Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on dem and ( prn ) in men with PE and ED who were being treated with PDE5 inhibitors . METHODS This r and omized , double-blind , placebo-controlled , flexible-dose , multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time ( IELT ) of ≤2 minutes in ≥75 % of sexual intercourse episodes ; were on stable regimen of a PDE5 inhibitor ; and had International Index of Erectile Function-erectile function domain score ≥21 . Subjects received placebo , dapoxetine 30 mg , or dapoxetine 60 mg prn ( 1 - 3 hours before intercourse ) for 12 weeks . MAIN OUTCOME MEASURE Stopwatch-measured average IELT , Clinical Global Impression of Change ( CGIC ) in PE , Premature Ejaculation Profile ( PEP ) , and treatment-emergent adverse events ( TEAEs ) . RESULTS Of 495 subjects r and omized , 429 completed the study . Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point ( 5.2 vs. 3.4 minutes ) and weeks 4 , 8 , and 12 ( P ≤ 0.002 for all ) . Men who described their PE at least " better " using the CGIC were significantly greater with dapoxetine vs. placebo at end point ( 56.5 % vs. 35.4 % ) and weeks 4 , 8 , and 12 ( P ≤ 0.001 for all ) . Significantly better outcomes were also reported with dapoxetine vs.  placebo on PEP measures . Incidence of TEAEs was 20.0 % and 29.6 % in placebo- and dapoxetine-treated subjects , respectively ( P = 0.0135 ) . TEAEs led to discontinuation in 1.6 % of subjects in both groups . Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea ( 9.2 % ) , headache ( 4.4 % ) , diarrhea ( 3.6 % ) , dizziness ( 2.4 % ) , and dizziness postural ( 2.4 % ) . CONCLUSIONS In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor , dapoxetine provided meaningful treatment benefit and was generally well tolerated
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 ) .