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| References
- Erection Problems |
| Morales
A, Gingell C, Collins M, Wicker PA, Osterloh IH. Clinical
safety of oral sildenafil citrate (VIAGRA) in the treatment
of erectile dysfunction. Int.J Impot.Res. 1998;10:69-73.
Abstract: Sildenafil citrate has been shown to be effective
in a wide range of patients with erectile dysfunction and
has been approved in the United States for this indication.
The overall clinical safety of oral sildenafil, a potent inhibitor
of phosphodiesterase type 5, in the treatment of erectile
dysfunction was evaluated in more than 3700 patients (with
a total of 1631 years of exposure worldwide). Safety and tolerability
data were analysed from a series of double-blind, placebo-
controlled studies and from 10 open-label extension studies
of sildenafil in the treatment of erectile dysfunction. A
total of 4274 patients (2722 sildenafil, 1552 placebo; age
range 19-87 y) received double-blind treatment over a period
of up to six months' duration, and 2199 received long-term,
open-label sildenafil for up to 1 y. The most commonly reported
adverse events (all causes) were headache (16% sildenafil,
4% placebo), flushing (10% sildenafil, 1% placebo), and dyspepsia
(7% sildenafil, 2% placebo) and they were predominantly transient
and mild or moderate in nature. These adverse events reflect
the pharmacology of sildenafil as a phosphodiesterase type
5 inhibitor. No cases of priapism were reported. The rate
of discontinuation due to adverse events (all causes) was
comparable for patients treated with sildenafil (2.5%) and
placebo (2.3%). In open-label extension studies, 90% of patients
completed long-term sildenafil treatment, with only 2% withdrawing
due to adverse events. Sildenafil is a well-tolerated oral
treatment for erectile dysfunction
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