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Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group.
N Engl J Med. 1998 May 14; 338(20):1397-404.NEJM

Abstract

BACKGROUND

Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] 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, and mixed causes.

METHODS

In a 24-week dose-response study, 532 men were treated with oral sildenafil (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 dose-escalation 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.

Authors+Show Affiliations

Department of Urology, Boston University Medical Center, MA 02118, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9580646

Citation

Goldstein, I, et al. "Oral Sildenafil in the Treatment of Erectile Dysfunction. Sildenafil Study Group." The New England Journal of Medicine, vol. 338, no. 20, 1998, pp. 1397-404.
Goldstein I, Lue TF, Padma-Nathan H, et al. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med. 1998;338(20):1397-404.
Goldstein, I., Lue, T. F., Padma-Nathan, H., Rosen, R. C., Steers, W. D., & Wicker, P. A. (1998). Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. The New England Journal of Medicine, 338(20), 1397-404.
Goldstein I, et al. Oral Sildenafil in the Treatment of Erectile Dysfunction. Sildenafil Study Group. N Engl J Med. 1998 May 14;338(20):1397-404. PubMed PMID: 9580646.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. AU - Goldstein,I, AU - Lue,T F, AU - Padma-Nathan,H, AU - Rosen,R C, AU - Steers,W D, AU - Wicker,P A, PY - 1998/5/15/pubmed PY - 1998/5/15/medline PY - 1998/5/15/entrez SP - 1397 EP - 404 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 338 IS - 20 N2 - BACKGROUND: Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] 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, and mixed causes. METHODS: In a 24-week dose-response study, 532 men were treated with oral sildenafil (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 dose-escalation 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. SN - 0028-4793 UR - https://www.unboundmedicine.com/medline/citation/9580646/Oral_sildenafil_in_the_treatment_of_erectile_dysfunction__Sildenafil_Study_Group_ L2 - http://www.nejm.org/doi/full/10.1056/NEJM199805143382001?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -