Oral sildenafil in the treatment of erectile dysfunction

Abstract

No AccessJournal of Urology1 Feb 2002Oral sildenafil in the treatment of erectile dysfunction Irwin Goldstein, M.D. Tom F. Lue, M.D. Harin Padma-Nathan, M.D. Raymond C. Rosen, Ph.D. William D. Steers, M.D. Pierre A. Wicker, andM.D. Sildenafil Study Group Irwin GoldsteinIrwin Goldstein , Tom F. LueTom F. Lue , Harin Padma-NathanHarin Padma-Nathan , Raymond C. RosenRaymond C. Rosen , William D. SteersWilliam D. Steers , Pierre A. WickerPierre A. Wicker , and Sildenafil Study Group View All Author Informationhttps://doi.org/10.1016/S0022-5347(02)80386-XAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Background Sildenafil is a potent inhibitor of cyclic guanosine monophosphate in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, or mixed causes. Methods In a 24-week dose-response study, 532 men were treated with oral sildenaffi (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this doseescalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. Results In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. Conclusions Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction. References 1. : Impotence. JAMA1993; 270: 83. 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Google Scholar © 2002 by American Urological Association, IncFiguresReferencesRelatedDetails Volume 167Issue 2 Part 2February 2002Page: 1197-1203 Advertisement Copyright & Permissions© 2002 by American Urological Association, IncMetrics Author Information Irwin Goldstein From the Department of Urology, Boston University Medical Center, Boston More articles by this author Tom F. Lue Department of Urology, University of California, San Francisco More articles by this author Harin Padma-Nathan Department of Urology, University of Southern California, Los Angeles Male Clinic, Santa Monica, Calif. More articles by this author Raymond C. Rosen Department of Psychiatry, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, N.J. More articles by this author William D. Steers Department of Urology University of Virginia, Charlottesville More articles by this author Pierre A. Wicker Pfizer Central Research, Groton, Conn. 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