The following article was published in the June issue of the International Journal of Impotence Research (Volume 10, Issue 2).
Have PFun!
BigKNY3
______________________________________
Clinical safety of oral sildenafil citrate (VIAGRA TM) in the treatment of erectile dysfunction
A Morales1,5, C Gingell2, M Collins3, PA Wicker4 & IH Osterloh3
1Department of Urology, Queen's University, Kingston General Hospital, Kingston, Ontario, Canadaÿÿÿÿ 2Urology Department, Southmead Hospital, Bristol, UKÿÿÿÿ 3Pfizer Central Research, Sandwich, UKÿÿÿÿ 4Pfizer Central Research, Groton, Connecticut, USAÿÿÿÿ
5Correspondence: Dr A Morales, Department of Urology, Kingston General Hospital, Victory 4, Kingston, Ontario K7L2V7, Canada.
Keywordserectile dysfunction;ÿÿ sildenafil;ÿÿ phosphodiesterase type 5 inhibitor;ÿÿ safety
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 19-87ÿy) received double-blind treatment over a period of up to six months' duration, and 2199 received long-term, open-label sildenafil for up to 1ÿy. 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.
Received 27 March 1998; Revised 14 April 1998; Accepted 14 April 1998 |
