In the three years since its launch, sildenafil citrate (Viagra (R)), an or
al agent for the treatment of erectile dysfunction (ED), has been prescribe
d to more than 10 million patients worldwide and has been further evaluated
in clinical studies in diverse patient populations. Significant improvemen
ts in erectile function have been demonstrated in double-blind, placebo-con
trolled trials in patients with ED and underlying diabetes, cardiovascular
disease, minor depression, spinal cord injury and multiple sclerosis, Promi
sing results have also been reported for patients with treated prostate can
cer, end-stage renal failure, Parkinson's disease, and spina bifida and in
multiple organ transplant recipients. Accounts of sildenafil use in clinica
l practice and postmarketing data reflect clinical trial findings of effect
iveness in a broad spectrum of ED aetiologies and overall good tolerability
. As in the clinical trials, most adverse events associated with sildenafil
use have been transient, mild or moderate effects that rarely lead to trea
tment discontinuation.