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Original ArticleOpen Access
The Efficacy and Safety of Oral Sildenafil in Thai Men with Erectile Dysfunction : A Randomized, Double-Blind, Placebo Controlled, Flexible-Dose Study
Kongkanand A 
,
RatanaOlarn K ,
Ruangdilokrat M ,
Tantiwong A ,
the F
,
RatanaOlarn K ,
Ruangdilokrat M ,
Tantiwong A ,
the F Objective : To evaluate the efficacy and safety of sildenafil citrate (Viagra"') in a randomized,
double-blind, placebo-controlled, flexible-dose study in Thai men with erectile dysfunction of broad-
spectrum etiology and more than 6 months' duration.
Material and Method : 125 patients aged 26 to 77 years were randomized at 4 centers in
Thailand to receive either sildenafil citrate (50 mg initially, increased if necessary up to 100 mg or
decreased to 25 mg depending on efficacy and/or tolerability) (n
=
63) or a matching placebo (n
=
62)
taken on an 'as needed' basis approximately I hour prior to anticipated sexual activity for a period
of 12 weeks. Efficacy was assessed by the patients' responses to the IS-question International Index
of Erectile Function (liEF), to questions on the event log of sexual activity, and to the global efficacy
assessment question concerning improvement in erections.
Results : At the conclusion of the study, both the primary efficacy variables relating to the
achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy
variables, which included the 5 separate domains of sexual functioning of the liEF, the percentage of
successful attempts at sexual intercourse, and the global efficacy assessment question concerning
improvement in erections, were all significantly improved statistically by sildenafil in comparison
with placebo except in the sexual desire domain which showed no difference. The percentage of
successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the
placebo group it was 33.05 per cent. The percentage of global efficacy assessment was improved in the
sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group. Adverse events con-
sidered treatment-related occurred in 19 patients (30.2%) receiving sildenafil and 7 (11.3%) receiving
placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache,
and dizziness, which occurred in 14.3 per cent, 6.3 per cent, and 6.3 per cent of patients respectively.
All events were mild in nature.
196
A. KONGKANAND
et
double-blind, placebo-controlled, flexible-dose study in Thai men with erectile dysfunction of broad-
spectrum etiology and more than 6 months' duration.
Material and Method : 125 patients aged 26 to 77 years were randomized at 4 centers in
Thailand to receive either sildenafil citrate (50 mg initially, increased if necessary up to 100 mg or
decreased to 25 mg depending on efficacy and/or tolerability) (n
=
63) or a matching placebo (n
=
62)
taken on an 'as needed' basis approximately I hour prior to anticipated sexual activity for a period
of 12 weeks. Efficacy was assessed by the patients' responses to the IS-question International Index
of Erectile Function (liEF), to questions on the event log of sexual activity, and to the global efficacy
assessment question concerning improvement in erections.
Results : At the conclusion of the study, both the primary efficacy variables relating to the
achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy
variables, which included the 5 separate domains of sexual functioning of the liEF, the percentage of
successful attempts at sexual intercourse, and the global efficacy assessment question concerning
improvement in erections, were all significantly improved statistically by sildenafil in comparison
with placebo except in the sexual desire domain which showed no difference. The percentage of
successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the
placebo group it was 33.05 per cent. The percentage of global efficacy assessment was improved in the
sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group. Adverse events con-
sidered treatment-related occurred in 19 patients (30.2%) receiving sildenafil and 7 (11.3%) receiving
placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache,
and dizziness, which occurred in 14.3 per cent, 6.3 per cent, and 6.3 per cent of patients respectively.
All events were mild in nature.
196
A. KONGKANAND
et
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