Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline.

INTRODUCTION

Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear.

AIM

To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline.

METHODS

Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5 mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period.

MAIN OUTCOME MEASURES

Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models.

RESULTS

Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (± standard deviation) age was 58.2 ± 10.7 years; and most subjects had ED for ≥ 1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5 mg and to 46.4% with tadalafil 5 mg (each P < 0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5 mg and from 24.4% to 66.2% with 5 mg (each P < 0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5 mg and from 10.7 to 19.2 with 5 mg (each P < 0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo.

CONCLUSIONS

The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5 mg and 5 mg, respectively, in men with no successful intercourse attempts at baseline.