Sildenafil citrate (Viagra) in erectile dysfunction: Near normalization inmen with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects
Ww. Dinsmore et al., Sildenafil citrate (Viagra) in erectile dysfunction: Near normalization inmen with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects, UROLOGY, 53(4), 1999, pp. 800-805
Objectives. To evaluate the efficacy, safety, and tolerability of sildenafi
l in men with broad-spectrum erectile dysfunction (ED), with reference to a
ge-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. Ef
ficacy assessments included the International Index of Erectile Function (I
IEF), a global assessment question, and patient event log data. In a separa
te, 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 obse
rved 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 therap
y for the treatment of broad-spectrum ED, is associated with a near normali
zation of patient erectile function. (C) 1999, Elsevier Science Inc. All ri
ghts reserved.