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Efficacy and safety of on‐demand tadalafil for the treatment of erectile dysfunction in South‐East Asian men
Author(s) -
GUO YING LU,
ZHU JI CHUAN,
PAN TIAN MING,
DING QIANG,
WANG YI XIN,
CHEONG NG FOO,
LIM EDWIN,
SHEN WEI,
VENUGOPALAN MURALI,
CHAN MELANIE
Publication year - 2006
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/j.1442-2042.2006.01393.x
Subject(s) - tadalafil , medicine , erectile dysfunction , placebo , adverse effect , randomized controlled trial , cgmp specific phosphodiesterase type 5 , urology , alternative medicine , pathology
Aim: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on‐demand tadalafil for the treatment of ED in South‐East Asian men. Methods: This was a randomized, double‐blind, placebo‐controlled study of men with mild to severe ED of various etiologies randomized to receive placebo ( n = 122), tadalafil 10 mg ( n = 120), or tadalafil 20 mg ( n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). Results: Men from China, Singapore, and the Philippines participated in this trial ( n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes ( P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF‐EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per‐patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group ( P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group ( P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. Conclusions: Tadalafil was an effective and well‐tolerated treatment for South‐East Asian men with ED.