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. Google Scholar 2. : Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol1994; 151: 54. Link, Google Scholar 3. Age and sexual outlet. In: Sexual behavior in the human male. Edited by . Philadelphia: W.B. Saunders1948: 218. Google Scholar 4. : Efficacy and safety of intracavernosal alprostadil in men with erectile dysfunction. N Engl J Med1996; 334: 873. Google Scholar 5. : Treatment of men with erectile dysfunction with transurethral alprostadil. N Engl J Med1997; 336: 1. Google Scholar 6. : Clinical Guidelines Panel on Erectile Dysfunction: summary report on the treatment of organic erectile dysfunction. J Urol1996; 156: 2007. Link, Google Scholar 7. : Nitric oxide as a mediator of relaxation of the corpus cavernosum in response to nonadrenergic, noncholinergic neurotransmission. N Engl J Med1992; 326: 90. Crossref, Medline, Google Scholar 8. : Physiology of penile erection. Physiol Rev1995; 75: 191. Crossref, Medline, Google Scholar 9. : The role of nitric oxide in the physiology of erection. Biol Reprod1995; 52: 485. Google Scholar 10. : Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impot Res1996; 8: 47. Google Scholar 11. : Sildenafil, a novel inhibitor of phosphodiesterase type 5 in human corpus cavernosum smooth muscle cells. Life Sci1998; 62: PL. Google Scholar 12. : Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol1996; 78: 257. Google Scholar 13. : The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology1997; 49: 822. Crossref, Medline, Google Scholar 14. : Impotence and its non-surgical management. Br J Clin Pract1997; 51: 99. 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 Hari