Efficacy and safety of on-demand oral tadalafil in the treatment of men with erectile dysfunction in Taiwan: a randomized, double-blind, parallel, placebo-controlled clinical study.
BACKGROUND
Tadalafil is a phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (ED). Past clinical trials have assessed its efficacy and safety in western populations. Tadalafil has not been investigated in a large clinical trial with a South-east Asian population.


OBJECTIVE
To assess the efficacy and safety of on-demand tadalafil for the treatment of ED in a 12-week, double-blind, placebo-controlled study in Taiwan.


METHODS
Men with mild to severe ED of various etiologies were randomized to receive placebo, tadalafil 10 mg, or tadalafil 20 mg, taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ).


RESULTS
Tadalafil significantly improved erectile function compared with placebo (P < 0.005, all measures). At endpoint, the patients receiving tadalafil reported a greater mean per-patient percentage of successful intercourse attempts (SEP question 3: 70.0%, 10 mg; 78.0%, 20 mg) than placebo-treated patients (42.8%) and a greater proportion of improved erections (GAQ: 92.3% and 84.6% vs. 54.5%). Most treatment-emergent adverse events were mild or moderate. The most common adverse events were back pain, dyspepsia, and myalgia.


CONCLUSIONS
Tadalafil was an effective, well-tolerated therapy for men in Taiwan with ED of broad-spectrum severity and etiology.
Chen
Kuang-Kuo
KK
Department of Surgery, Taipei Veterans General Hospital, Taiwan. kkchen@vghtpe.gov.tw
Jiann
Bang-Ping
BP
Lin
Johnny Shinn-Nan
JS
Lee
Shang-Sen
SS
Huang
Shih-Tsung
ST
Wang
Chii-Jye
CJ
Ju-Ton
Hsieh
H
Su
Chung-Kuang
CK
Costigan
Timothy M
TM
Emmick
Jeffrey T
JT
D000284:Administration, Oral; D000368:Aged; D001416:Back Pain / Q000139:chemically induced; D002243:Carbolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D000068581:Tadalafil; D013624:Taiwan; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D000068581:Tadalafil