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Sildenafil (Viagra) Safe and Effective for Erectile Dysfunction After Renal Transplant: Presented at WCN

By Bruce Sylvester

BERLIN, GERMANY -- June 20, 2003 -- Sildenafil (Viagra) is a safe and effective treatment for erectile dysfunction (ED) in renal transplant patients, and does not affect levels of cyclosporine (CsA) in blood, researchers reported here on June 9^th at the annual World Congress on Nephrology.

"This study showed that male renal transplant patients, who commonly suffer postsurgical erectile dysfunction, can safely and very effectively use this common medication to address the problem and to recover more normally satisfying sexual activities," said R.K. Sharma, MD, PhD, a clinician and researcher in nephrology and urology at the Sanjay Gandhi Post Graduate Institute of Medical Sciences, in Lucknow, India.

ED occurs in 41% to 93% of patients with chronic renal failure (CRF) undergoing dialysis. Previous research showed that 60% to 75% of patients recover full sexual function after renal transplantation.

To evaluate the safety and efficacy of sildenafil in men who underwent renal transplantation, Dr. Sharma and colleagues conducted a crossover, placebo-controlled study in 30 renal allograft recipients who reported ED.

The subjects received sildenafil at doses of 25-100 mg (mean dose, 50 mg) 1 hour before anticipated sexual activity and after completing the International Index of Erectile Function (IIEF).

The researchers administered placebo and sildenafil in a blinded manner, and the study included a washout period. They analysed individual patient data for improvement in IIEF score and global efficacy question at the end of the 2 study periods.

Mean age of subjects was 40 years, and mean time elapsed since transplantation was 4.7 years. Mean period since onset of ED was 17.5 months.

Mean IIEF score improved significantly for all items on the questionnaire with sildenafil treatment compared with baseline scores (P<0.001), while mean scores in the placebo group were similar pre- and posttreatment.

Analysis of the global efficacy question indicated that 26 out of 30 patients improved after sildenafil therapy.

The researchers saw no change in graft function (serum creatinine 1.48 vs. 1.4 mg/dL) and CsA level (90 vs. 91 ng/mL) pre- and posttreatment with sildenafil. In a subgroup of 4 patients, mean area under the curve of cyclosporine was similar with and without sildenafil treatment (7454 vs. 7460 ng-hr/mL).

Five subjects reported mild headache, 1 reported generalised body ache, 2 reported mild rhinorrhoea, and 1 had visual symptoms. One subject with visual symptoms discontinued active treatment.

"Sildenafil can be used safely and is an effective form of therapy for erectile dysfunction in renal transplant patients, and it does not affect the CsA blood levels," the authors concluded.


[Study title: Treatment of Erectile Dysfunction With Sildenafil Citrate In Renal Transplant Recipient: A Cross Over Placebo Controlled Trial. Abstract M760]

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