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CLINICAL ABSTRACTS: MEN’S HEALTH

Title: CLINICAL ABSTRACTS: MEN’S HEALTH ,  Modern Medicine, 00268070, Apr99, Vol. 67, Issue 4



Sildenafil effective for erectile dysfunction in diabetic men

Oral Sildenafil appears to be an effective and well-tolerated treatment for organic erectile dysfunction in men with diabetes. The efficacy of this selective inhibitor of phosphodiesterase type 5 (PDE5) “suggests that PDE5 activity remains at least partially intact in diabetes,” according to the Sildenafil Diabetes Study Group, a collaborative of researchers from 19 clinical research centers throughout the United States.

A total of 268 diabetic men (mean age: 57) with organic erectile dysfunction (mean duration: 5.6 years) were randomized to oral Sildenafil citrate (n = 136) or placebo (n = 132) on an as-needed basis for 12 weeks. The patients were instructed to take their treatment 1 hour before sexual activity but not more than once daily. The initial dose of Sildenafil was 50 rog, and this dose could be increased to 100 mg or decreased to 25 mg or placebo based on the investigators’ judgement of efficacy and tolerability.

EFFICACY, The efficacy of treatment was assessed using the International Index of Erectile Function (IIEF) questionnaire, a self-administered, 15-question measure of erectile dysfunction. An increase in mean scores on 2 of the 15 IIEF questions was significantly greater in the Sildenafil group (78% and 93%, respectively) than in the placebo group (25% and 14%, respectively). Patient age, the duration of erectile dysfunction, and the duration of diabetes did not alter the improvements in these three efficacy variables. The Sildenafil group showed significantly greater improvements on 11 of the remaining 13 IIEF questions. Among these efficacy variables were questions related to orgasmic function, satisfaction with sexual intercourse, and overall satisfaction. Furthermore, a significantly greater proportion of the Sildenafil group reported at least one successful attempt at intercourse (61% vs 22% for placebo).

Patients were also asked a global efficacy question (”Did treatment improve your erections?”), to which 56% of the Sildenafil group and 10% of the placebo group reported an improvement.

ADVERSE EVENTS. Sixteen percent of the Sildenafil group and 1% of the placebo group reported treatment-related adverse events. However, these adverse events were transient and mild to moderate in nature and did not cause any of the Sildenafil -treated patients to withdraw from the study.

The most common adverse events in the Sildenafil group were headache (11%), dyspepsia (9%), and respiratory tract disorder such as sinus congestion or drainage (6%). Furthermore, there were no between-group differences in the incidence of cardiovascular adverse events (3% with Sildenafil and 5% with placebo).


INTERVIEW



Larry Lipshultz, MD

Dr. Lipshultz is Professor of Urology at Baylor College of Medicine in Houston, Tex.

Dr. Lipshultz discussed the significance of this study In an interview with MODERN MEDICINE. “This is one of the first studies to come out looking at sub-groups of patients with erectile dysfunction and a specific disease, in terms of how they respond to oral agents like Viagra.” In this case, “we are looking at a large group of men with diabetes as their primary disease and what we see is about a 60% response rate. Since erectile dysfunction is so common in men with diabetes, their ability to have some form of oral therapy is extremely important.

I believe that this is something that primary care physicians can begin to offer immediately. The one caveat Is that you ere not supposed to use Viagra in patients who have active coronary artery disease or who have a history of recent mild cardiac dysfunction. Diabetics are at high risk because they have increased incidence of vascular disease. Therefore, physicians have to make sure that their patients do not fall into this category before they offer it.”


SOURCE



JAMA

Rendell MS, Rajfer J, Wicker PA, Smith MD, Sildenafil Diabetes Study Group. Sildenafil for treatment of erectile dysfunction in men with diabetes: A randomized controlled trial. JAMA (Feb. 3) 1999;281:421-6.


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Source: Modern Medicine, Apr99, Vol. 67 Issue 4, p43, 1p

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