Abstract
Objectives. To evaluate the efficacy, safety, and tolerability of sildenafil in men
with broad-spectrum erectile dysfunction (ED), with reference to age-matched healthy
control subjects.
Methods. One hundred eleven patients were enrolled in a randomized, double-blind,
placebo-controlled, parallel-group, 12-week, flexible-dose study. Efficacy assessments
included the International Index of Erectile Function (IIEF), a global assessment
question, and patient event log data. In a separate, nontreatment study, 109 control
subjects also completed the IIEF.
Results. Mean IIEF scores at baseline were significantly lower for patients with ED
than for control subjects without a history of ED. After treatment, mean IIEF scores
for patients receiving sildenafil approached values observed in control subjects and
were significantly higher than mean scores for patients receiving placebo (P <0.01). Responses to the global assessment question and patient log data corroborated
the IIEF results. Sildenafil was well tolerated, with no discontinuations because
of adverse events.
Conclusions. The results indicate that sildenafil, an effective oral therapy for the
treatment of broad-spectrum ED, is associated with a near normalization of patient
erectile function.
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Article info
Publication history
Received:
August 17,
1998
Footnotes
☆This study was funded by Pfizer Inc.
Identification
Copyright
© 1999 Elsevier Science Inc. Published by Elsevier Inc. All rights reserved.
