OBJECTIVE: To evaluate the efficacy and safety of vardenafil in kidney transplant recipients with erectile dysfunction. METHODS:Thirty-nine kidney transplant recipients with erectile dysfunction (ED) and serum creatinine values <2 mg/dl were enrolled in a 4-week randomized, double blind, placebo-controlled study, 19 treated with placebo and 20 with vardenafil. Vardenafil efficacy was assessed with the IIEF questionnaire after 4 weeks of treatment, and its safety appraised by measuring serum creatinine levels, creatinine clearances and cyclosporine concentrations before and after the treatment. RESULTS:IIEF scores improved from 12.6 +/- 3.4 to 26.5 +/- 2.8 (P < 0.01), but renal function and cyclosporine concentrations remained unchanged in the vardenafil-treated patients. Adverse effects were observed in 4 patients: headache in 2, palpitation and flush in 1, and dyspepsia in the other. CONCLUSION:Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for kidney transplant recipients with ED.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of vardenafil in kidney transplant recipients with erectile dysfunction. METHODS: Thirty-nine kidney transplant recipients with erectile dysfunction (ED) and serum creatinine values <2 mg/dl were enrolled in a 4-week randomized, double blind, placebo-controlled study, 19 treated with placebo and 20 with vardenafil. Vardenafil efficacy was assessed with the IIEF questionnaire after 4 weeks of treatment, and its safety appraised by measuring serum creatinine levels, creatinine clearances and cyclosporine concentrations before and after the treatment. RESULTS: IIEF scores improved from 12.6 +/- 3.4 to 26.5 +/- 2.8 (P < 0.01), but renal function and cyclosporine concentrations remained unchanged in the vardenafil-treated patients. Adverse effects were observed in 4 patients: headache in 2, palpitation and flush in 1, and dyspepsia in the other. CONCLUSION: Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for kidney transplant recipients with ED.
Authors: Mariacristina Vecchio; Sankar D Navaneethan; David W Johnson; Giuseppe Lucisano; Giusi Graziano; Marialuisa Querques; Valeria Saglimbene; Marinella Ruospo; Carmen Bonifati; Emmanuele A Jannini; Giovanni F M Strippoli Journal: Clin J Am Soc Nephrol Date: 2010-05-24 Impact factor: 8.237