Open AccessEfficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double‐blind, parallel, placebo‐controlled clinical study
Author(s) -
Yip Wai Chun Andrew,
Chiang HanSun,
Mendoza Jesus Benjamin,
Tan HuiMeng,
Li ManKay,
Wang Wei Christine,
Kopernicky Vladimir
Publication year - 2006
Publication title -
asian journal of andrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.701
H-Index - 74
eISSN - 1745-7262
pISSN - 1008-682X
DOI - 10.1111/j.1745-7262.2006.00213.x
Subject(s) - tadalafil , placebo , medicine , erectile dysfunction , adverse effect , randomized controlled trial , clinical trial , clinical endpoint , physical therapy , alternative medicine , pathology
Aim: To 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). Methods: This 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. Results: Tadalafil 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 (≤ 3%) treatment emergent adverse events were mild or moderate. The most common treatment emergent adverse events were headache, back pain, dizziness and dyspepsia. Conclusion: Tadalafil was an effective and well‐tolerated treatment for ED in East and Southeast Asian men. Edited by Jae‐Seung Paick