CLINICAL SAFETY OF ORAL SILDENAFIL CITRATE (VIAGRA(TM)) IN THE TREATMENT OF ERECTILE DYSFUNCTION

Sildenafil citrate has been shown to be effective in a wide range of p atients with erectile dysfunction and has been approved in the United States for this indication. The overall clinical safety of oral silden afil, a potent inhibitor of phosphodiesterase type 5, in the treatment of erectile dysfunction was evaluated in more than 3700 patients (wit h a total of 1631 years of exposure worldwide). Safety and tolerabilit y 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 sil denafil, 1552 placebo; age range 19-87 y) received double-blind treatm ent over a period of up to six months' duration, and 2199 received lon g-term, open-label sildenafil for up to 1 y. The most commonly reporte d adverse events tall causes) were headache (16% sildenafil, 4% placeb o), flushing (10% sildenafil, 1% placebo), and dyspepsia (7% sildenafi l, 2% placebo) and they were predominantly transient and mild or moder ate in nature. These adverse events reflect the pharmacology of silden afil as a phosphodiesterase type 5 inhibitor. No cases of priapism wer e reported. The rate of discontinuation due to adverse events tall cau ses) was comparable for patients treated with sildenafil (2.5%) and pl acebo (2.3%). In open-label extension studies, 90% of patients complet ed long-term sildenafil treatment, with only 2% withdrawing due to adv erse events. Sildenafil is a well-tolerated oral treatment for erectil e dysfunction.