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| References
- Erection Problems |
| Goldstein
I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA.
Oral sildenafil in the treatment of erectile dysfunction. Sildenafil
Study Group. N.Engl.J Med. 1998;338:1397-404.
Abstract: BACKGROUND: Sildenafil is a potent inhibitor of
cyclic guanosine monophosphate hydrolysis [corrected] in the
corpus cavernosum and therefore increases the penile response
to sexual stimulation. We evaluated the efficacy and safety
of sildenafil, administered as needed in two sequential double-blind
studies of men with erectile dysfunction of organic, psychogenic,
and mixed causes. METHODS: In a 24-week dose- response study,
532 men were treated with oral sildenafil (25, 50, or 100
mg) or placebo. In a 12-week, flexible dose-escalation study,
329 different men were treated with sildenafil or placebo,
with dose escalation to 100 mg based on efficacy and tolerance.
After this dose- escalation study, 225 of the 329 men entered
a 32-week, open-label extension study. We assessed efficacy
according to the International Index of Erectile Function,
a patient log, and a global-efficacy question. RESULTS: In
the dose-response study, increasing doses of sildenafil were
associated with improved erectile function (P values for increases
in scores for questions about achieving and maintaining erections
were <0.001). For the men receiving 100 mg of sildenafil,
the mean score for the question about achieving erections
was 100 percent higher after treatment than at base line (4.0
vs. 2.0 of a possible score of 5). In the last four weeks
of treatment in the dose-escalation study, 69 percent of all
attempts at sexual intercourse were successful for the men
receiving sildenafil, as compared with 22 percent for those
receiving placebo (P<0.001). The mean numbers of successful
attempts per month were 5.9 for the men receiving sildenafil
and 1.5 for those receiving placebo (P<0.001). Headache,
flushing, and dyspepsia were the most common adverse effects
in the dose-escalation study, occurring in 6 percent to 18
percent of the men. Ninety-two percent of the men completed
the 32-week extension study. CONCLUSIONS: Oral sildenafil
is an effective, well-tolerated treatment for men with erectile
dysfunction
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