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Sildenafil Treatment Less Effective in Men With Diabetes Than in Non-Diabetics
A DGReview of :"Oral sildenafil in the treatment of erectile dysfunction in diabetic men; A randomized double-blind and placebo-controlled study"
Journal of Diabetes and its Complications
07/09/2004
By Shane Alexander
Oral sildenafil is only moderately effective in the treatment of erectile dysfunction in patients with diabetes, an Iranian researcher reports.
"The response rate was lower and cardiovascular events were higher than previously reported in nondiabetic patients," writes M. R. Safarinejad, MD, Department of Urology, Military University of Medical Sciences, Tehran.
A total of 282 men (mean age 46.4 years) with erectile dysfunction (mean duration 3.6 years) and diabetes (mean duration 11 years) were recruited for this randomised, double-blind, placebo-controlled trial.
Over the 16-week study period, 144 men were assigned to receive sildenafil 100 mg approximately 1 hour before sexual activity and 138 men received a matching placebo.
Treatment efficacy was evaluated using the International Index of Erectile Function questionnaire. Ninety-three percent of men in the sildenafil group and 93% of men in the placebo group completed the study.
The investigator reports positive clinical results in 51% of men in the sildenafil group compared with 11% of men in the placebo group (P < .003). In the sildenafil group, 59% of men noted at least 1 successful attempt at sexual intercourse compared with 21% of men in the placebo group (P < .002).
Adverse effects were reported by 22 % of men treated with sildenafil compared with 3 % of men in the placebo group. The most frequently reported adverse events were: headaches (sildenafil: 20%, placebo: 2%), flushing (sildenafil: 19%, placebo: 0%), rhinitis (sildenafil: 6%, placebo: 0%), and cardiovascular events (sildenafil: 7%, placebo: 0%).
Two percent of patients treated with sildenafil reported new chest pain; myocardial infarction was documented in half of those patients.
J Diabetes Complications 2004 Jul-Aug;18:4:205-10
"Oral sildenafil in the treatment of erectile dysfunction in diabetic men; A randomized double-blind and placebo-controlled study"
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