This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (263)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in JAMA  Topic Collections  • Diabetes Mellitus  • Randomized Controlled Trial  • Alert me on articles by topic

A Randomized Controlled Trial

Marc S. Rendell, MD; Jacob Rajfer, MD; Pierre A. Wicker, MD; Michael D. Smith, PhD; for the Sildenafil Diabetes Study Group

JAMA. 1999;281:421-426.

Context  Erectile dysfunction is common in men with diabetes.

Objective  To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes.

Design  A multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study conducted May through November 1996.

Setting  Patients' homes and 19 clinical practice centers in the United States.

Patients  A total of 268 men (mean age, 57 years) with erectile dysfunction (mean duration, 5.6 years) and diabetes (mean duration, 12 years).

Interventions  Patients were randomized to receive sildenafil (n=136) or placebo (n=132) as needed, but not more than once daily, for 12 weeks. Patients took the study drug or placebo 1 hour before anticipated sexual activity. The starting dose of sildenafil citrate was 50 mg, with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability, to be taken as needed.

Main Outcome Measures  Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events.

Results  Two hundred fifty-two patients (94%) completed the study (131/136 in the sildenafil group, 121/132 in the placebo group). By intention-to-treat analysis, at 12 weeks, 74 (56%) of 131 patients in the sildenafil group reported improved erections compared with 13 (10%) of 127 patients in the placebo group (P<.001). The proportion of men with at least 1 successful attempt at sexual intercourse was 61% (71/117) for the sildenafil group vs 22% (25/114) for the placebo group (P<.001). Adverse events related to treatment were reported for 22 (16%) of 136 patients taking sildenafil and 1 (1%) of 132 patients receiving placebo. The most common adverse events were headache (11% sildenafil, 2% placebo), dyspepsia (9% sildenafil, 0% placebo), and respiratory tract disorder (6% sildenafil, 2% placebo), predominantly sinus congestion or drainage. The incidence of cardiovascular adverse events was comparable for both groups (3% sildenafil, 5% placebo).

Conclusion  Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes.

Author Affiliations: Creighton Diabetes Center, Omaha, Neb (Dr Rendell); Harbor-University of California, Los Angeles Medical Center, Torrance (Dr Rajfer); Pfizer Central Research, Groton, Conn (Dr Wicker) and Sandwich, England (Dr Smith). A complete list of the members of the Sildenafil Diabetes Study Group appears at the end of this article.

RELATED ARTICLES

Treatment of Erectile Dysfunction in Men With Diabetes
Larry I. Lipshultz and Edward D. Kim
JAMA. 1999;281(5):465-466.
EXTRACT | FULL TEXT  

February 3, 1999
JAMA. 1999;281(5):481-482.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Role of Oxidative Stress in the Pathophysiological Mechanism of Erectile Dysfunction
Agarwal et al.
J Androl 2006;27:335-347.
FULL TEXT  

Sildenafil in the Treatment of Antipsychotic-Induced Erectile Dysfunction: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose, Two-Way Crossover Trial
Gopalakrishnan et al.
Am. J. Psychiatry 2006;163:494-499.
ABSTRACT | FULL TEXT  

Sildenafil Improves Sleep-Related Erections in Hypogonadal Men: Evidence From a Randomized, Placebo-Controlled, Crossover Study of a Synergic Role for Both Testosterone and Sildenafil on Penile Erections
Rochira et al.
J Androl 2006;27:165-175.
ABSTRACT | FULL TEXT  

Phosphodiesterase 5 Inhibitors for Erectile Dysfunction
Setter et al.
The Annals of Pharmacotherapy 2005;39:1286-1295.
ABSTRACT | FULL TEXT  

A double blind, randomised study of sildenafil citrate for erectile dysfunction in men with multiple sclerosis
Fowler et al.
J. Neurol. Neurosurg. Psychiatry 2005;76:700-705.
ABSTRACT | FULL TEXT  

Erectile Dysfunction in Diabetic Patients
Penson and Wessells
Diabetes Spectr. 2004;17:225-230.
ABSTRACT | FULL TEXT  

Oxidative Stress and Antioxidant Therapy: Their Impact in Diabetes-Associated Erectile Dysfunction
De Young et al.
J Androl 2004;25:830-836.
ABSTRACT | FULL TEXT  

Advances in the Treatment of Erectile Dysfunction: A Focus on Tadalafil
Norwood et al.
Journal of Pharmacy Practice 2004;17:239-250.
ABSTRACT  

A 66-Year-Old Man With Sexual Dysfunction
Morgentaler
JAMA 2004;291:2994-3003.
FULL TEXT  

Erectile Dysfunction After Open Versus Angioplasty Aortoiliac Procedures: A Questionnaire Survey
Karkos et al.
VASC ENDOVASCULAR SURG 2004;38:157-165.
ABSTRACT  

Pharmacokinetics, Pharmacodynamics, and Efficacy of Phosphodiesterase Type 5 Inhibitors
Sussman
JAOA: Journal of the American Osteopathic Association 2004;104:11S-15S.
ABSTRACT | FULL TEXT  

Cognitive Changes Predict Continued Recovery of Erectile Functioning Versus Relapse After Discontinuation of Sildenafil Treatment for Male Erectile Dysfunction
van Lankveld et al.
Psychosom. Med. 2003;65:709-718.
ABSTRACT | FULL TEXT  

Do Impotent Men With Diabetes Have More Severe Erectile Dysfunction and Worse Quality of Life Than the General Population of Impotent Patients?: Results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction (ExCEED) database
Penson et al.
Diabetes Care 2003;26:1093-1099.
ABSTRACT | FULL TEXT  

Vardenafil, a New Phosphodiesterase Type 5 Inhibitor, in the Treatment of Erectile Dysfunction in Men With Diabetes: A multicenter double-blind placebo-controlled fixed-dose study
Goldstein et al.
Diabetes Care 2003;26:777-783.
ABSTRACT | FULL TEXT  

Sildenafil Citrate for Treatment of Erectile Dysfunction in Men With Type 1 Diabetes: Results of a randomized controlled trial
Stuckey et al.
Diabetes Care 2003;26:279-284.
ABSTRACT | FULL TEXT  

Treatment of Antidepressant-Associated Sexual Dysfunction With Sildenafil: A Randomized Controlled Trial
Nurnberg et al.
JAMA 2003;289:56-64.
ABSTRACT | FULL TEXT  

Effects of Tadalafil on Erectile Dysfunction in Men With Diabetes
Saenz de Tejada et al.
Diabetes Care 2002;25:2159-2164.
ABSTRACT | FULL TEXT  

Challenges in Oral Therapy for Erectile Dysfunction
Seftel
J Androl 2002;23:729-736.
FULL TEXT  

Acute and Prolonged Effects of Sildenafil on Brachial Artery Flow-Mediated Dilatation in Type 2 Diabetes
Desouza et al.
Diabetes Care 2002;25:1336-1339.
ABSTRACT | FULL TEXT  

Erectile dysfunction in patients with diabetes mellitus -- advances in treatment with phosphodiesterase type 5 inhibitors
Snow
British Journal of Diabetes & Vascular Disease 2002;2:282-287.
ABSTRACT  

Sildenafil citrate in the management of diabetic erectile dysfunction
Hackett
British Journal of Diabetes & Vascular Disease 2002;2:306-308.
ABSTRACT  

Effects of Sildenafil on Nocturnal Penile Tumescence and Rigidity in Normal Men: Randomized, Placebo-Controlled, Crossover Study
Rochira et al.
J Androl 2002;23:566-571.
ABSTRACT | FULL TEXT  

Gene Therapy of Erectile Dysfunction in the Rat with Penile Neuronal Nitric Oxide Synthase
Magee et al.
Biol. Reprod. 2002;67:20-28.
ABSTRACT | FULL TEXT  

Sildenafil for Male Erectile Dysfunction: A Systematic Review and Meta-analysis
Fink et al.
Arch Intern Med 2002;162:1349-1360.
ABSTRACT | FULL TEXT  

The Impact of Clinical Trials on the Treatment of Diabetes Mellitus
Nathan
J. Clin. Endocrinol. Metab. 2002;87:1929-1937.
ABSTRACT | FULL TEXT  

Erectile Dysfunction and Quality of Life in Type 2 Diabetic Patients: A serious problem too often overlooked
De Berardis et al.
Diabetes Care 2002;25:284-291.
ABSTRACT | FULL TEXT  

Treatment of Erectile Dysfunction in Men With Depressive Symptoms: Results of a Placebo-Controlled Trial With Sildenafil Citrate
Seidman et al.
Am. J. Psychiatry 2001;158:1623-1630.
ABSTRACT | FULL TEXT  

Erectile dysfunction and the effects of sildenafil treatment in patients on haemodialysis and continuous ambulatory peritoneal dialysis
Turk et al.
Nephrol Dial Transplant 2001;16:1818-1822.
ABSTRACT | FULL TEXT  

Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction
EARDLEY et al.
Br. J. Psychiatry 2001;178:325-330.
ABSTRACT | FULL TEXT  

Efficacy of Oral Sildenafil in the Treatment of Erectile Dysfunction in Diabetic Men With Positive Response to Intracavernosal Injection of Alprostadil
Lepore and Nosari
Diabetes Care 2001;24:409-411.
FULL TEXT  

Sildenafil for Diabetic Men With Erectile Dysfunction
Garg et al.
JAMA 1999;282:939-941.
FULL TEXT  

Sexual Dysfunction in Uremia
PALMER
J. Am. Soc. Nephrol. 1999;10:1381-1388.
FULL TEXT  

Sildenafil (Viagra): Findings in Diabetic Men
JWatch Psychiatry 1999;1999:16-16.
FULL TEXT  

Sildenafil (Viagra) Effective for Erectile Dysfunction in Diabetic Men
JWatch General 1999;1999:2-2.
FULL TEXT  

Treatment of Erectile Dysfunction in Men With Diabetes
Lipshultz and Kim
JAMA 1999;281:465-466.
FULL TEXT