AIMTo assess the efficacy and safety of tadalafil in comparison to a placebo, when taken on demand for 12 weeks by East/Southeast Asian men with erectile dysfunction (ED).

METHODSThis multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August 2002 and February 2003. Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive a placebo or 20 mg of tadalafil taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile diary and Global Assessment Questions.

RESULTSTadalafil significantly improved erectile function as compared to the placebo (P < 0.001). At the endpoint, the patients receiving 20 mg of tadalafil reported a greater mean per patient percentage of successful intercourse attempts (Sexual Encounter Profile question 3: 70.9% compared to 33.5% in the placebo) and a greater proportion of improved erections (Global Assessment Question: 86.2% compared to 30.1%). Most (= or < 3%) treatment emergent adverse events were mild or moderate. The most common treatment emergent adverse events were headache, back pain, dizziness and dyspepsia.

CONCLUSIONTadalafil was an effective and well-tolerated treatment for ED in East and Southeast Asian men.

Adolescent ; Adult ; Aged ; Asia, Southeastern ; Carbolines ; adverse effects ; therapeutic use ; China ; Double-Blind Method ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Tadalafil ; Treatment Outcome

PURPOSE: Tadalafil is a phosphodiesterase type 5 inhibitor that is used for the treatment of erectile dysfunction (ED). Previous clinical trials have assessed its efficacy and safety in Western populations, but this drug has not been investigated in a large clinical trial involving Korean men with ED. Thus, the aim of this study was to assess the efficacy and safety of 20 mg tadalafil in comparison to placebo when it is taken on demand by Korean men suffering with ED over a study period of 12 weeks. MATERIALS AND METHODS: Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive placebo or tadalafil 20 mg that was taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary and Global Assessment Questions (GAQ). RESULTS: Tadalafil significantly improved erectile function, as measured by the erectile function domain of the IIEF, compared to placebo (p<0.001). At the endpoint, the patients receiving tadalafil 20mg reported a greater mean per-patient percentage of successful intercourse attempts (SEP3: 71% compared to 31% for placebo) and a greater proportion of improved erections (GAQ: 80% compared to 44%). The most common treatment emergent adverse events were headache (16.3%), flushing (5%) and eye pain (5%), and most of the adverse events were mild or moderate in severity. CONCLUSIONS: Tadalafil was an effective, well-tolerated therapy for Korean men suffering with ED of broad-spectrum severity and etiology.
Erectile Dysfunction* ; Eye Pain ; Flushing ; Headache ; Humans ; Korea* ; Male ; Tadalafil