Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group.
OBJECTIVE
To evaluate the efficacy, safety, and tolerability of oral sildenafil in Asian men with erectile dysfunction of various causes (organic, psychogenic, or mixed) and of more than 6 months' duration.


METHODS
In this double-blind, parallel-group trial conducted at eight centers in Malaysia, the Philippines, and Singapore, 254 men, 26 to 78 years old, were randomized to 12 weeks of sildenafil or placebo taken as needed 1 hour before anticipated sexual activity. Initially, the sildenafil (n = 127) or matching placebo (n = 127) dose was 50 mg but could be increased to 100 mg or decreased to 25 mg because of a lack of efficacy or intolerance, respectively. Efficacy was assessed by the 15-question International Index of Erectile Function, patients' event logs of sexual activity, and a global efficacy question about erections.


RESULTS
The two primary efficacy variables relating to achievement and maintenance of an erection sufficient for sexual intercourse, as assessed by the mean scores for International Index of Erectile Function question 3 (4.22 versus 2.59) and question 4 (4.15 versus 2.41), were both significantly higher with sildenafil than with placebo (P <0.0001). In addition, the five separate International Index of Erectile Function domains of sexual function, the percentage of successful intercourse attempts, and the global efficacy assessment of erections revealed significantly greater treatment effects in favor of sildenafil (P <0.0001 versus placebo for all variables). Treatment-related adverse events occurred in 22.8% of patients who received sildenafil and in 10.2% of those who received placebo.


CONCLUSIONS
Sildenafil is an effective and well-tolerated treatment for Asian men with erectile dysfunction of broad-spectrum etiology.
Tan
H M
HM
Subang Jaya Medical Centre, Selangor Darul Ehsan, Malaysia.
Moh
C L
CL
Mendoza
J B
JB
Gana
T
T
Albano
G J
GJ
de la Cruz
R
R
Chye
P L
PL
Sam
C C
CC
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D010679:Philippines; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011687:Purines; D000068677:Sildenafil Citrate; D012846:Singapore; D013450:Sulfones
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate