Effects of sildenafil and vardenafil on erectile dysfunction and health-related quality of life in haemodialysis patients: a prospective randomized crossover study.
BACKGROUND
Erectile dysfunction (ED) is prevalent in end-stage renal disease (ESRD) and has been associated with impaired health-related quality of life (HRQoL). HRQoL, in turn, is related to morbidity and mortality in ESRD patients. Previous studies have shown improved HRQoL with ED treatment using sildenafil and vardenafil. However, no study has examined the effects of sildenafil or vardenafil on HRQoL in impotent ESRD patients. Furthermore, vardenafil has never been tested and its safety profile has not been determined in ESRD patients. The aim of this randomized crossover study was to compare the effects of sildenafil and vardenafil on measures of HRQoL and on ED scores as well as to determine the safety profile of vardenafil in ESRD patients.


METHODS
In 32 haemodialysis patients with impotence, ED and HRQoL were evaluated by the International Index of Erectile Function (IIEF-5) and the 36-item Short-Form Health (SF-36) surveys, respectively. Patients were randomized into sildenafil and vardenafil groups. After a 4-week treatment and 2-week washout periods, crossover was performed and an additional 4-week treatment was administered. IIEF-5 and SF-36 surveys were given before and after each treatment period. Adverse effects were evaluated by interview. Friedman tests and Bonferroni-adjusted Wilcoxon signed-rank tests were used to compare groups and for post hoc analysis, respectively.


RESULTS
IIEF-5 and SF-36 scores were significantly improved by both sildenafil and vardenafil compared to pretreatment values. There were no differences between sildenafil and vardenafil with respect to the studied parameters. Adverse effect profiles were also similar. No patient dropped out because of side effects.


CONCLUSIONS
Sildenafil and vardenafil caused similar improvements in ED and HRQoL in haemodialysis patients. Vardenafil was well tolerated in our patient population.
Turk
Suleyman
S
Nephrology Department, Meram School of Medicine, Selcuk University, Meram, Konya, Turkey.
Solak
Yalcin
Y
Kan
Seyfullah
S
Atalay
Huseyin
H
Kilinc
Mehmet
M
Agca
Erhan
E
Bodur
Said
S
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D006435:Renal Dialysis / Q000523:psychology*; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use*; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride; D055815:Young Adult
D007093:Imidazoles; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride; D000068677:Sildenafil Citrate