Early experience with sildenafil for the treatment of erectile dysfunction in renal transplant recipients.
BACKGROUND
Erectile dysfunction (ED) is common in men with renal failure, but is not always alleviated following kidney transplant. The objective of the present study was to assess the feasibility in renal transplant patients of sildenafil citrate treatment, an agent with proven efficacy in the management of ED.


METHODS
This was a phase IV, open, multicentre, 3 month, dose-escalation study. All patients meeting the inclusion criteria were prescribed a dose of 50 mg sildenafil at the first visit. Thereafter the dose could be increased to 100 mg or reduced to 25 mg based on efficacy or tolerability. The primary efficacy parameter assessed the ability of patients to achieve erections sufficient for intercourse and to maintain erections after penetration. Secondary endpoints assessed patient satisfaction with sildenafil and the effect of sildenafil on their quality of life. Patients were carefully monitored throughout the study for adverse events, interactions with immunosuppressive therapy and effect on graft function.


RESULTS
The study included 50 patients in the intent-to-treat population. Sildenafil significantly improved patient's erection ability and the frequency of their erection maintenance. Analysis of the secondary efficacy parameters revealed that 66% of patients believed treatment had improved their erections. Patients reported improvements in their sexual life and partner relationships and a high level of satisfaction with treatment. There were no interactions between sildenafil and the immunosuppressive drugs and there was no significant adverse effect of sildenafil on graft function.


CONCLUSIONS
Sildenafil is an effective and well-tolerated agent for the treatment of ED in renal transplant recipients.
Barrou
Benoit
B
Transplantation Committee of the French Urological Association, Department of Urology, La Pitié-Salpêtrière University Hospital, 83 boulevard de l'hôpital, F-75013 Paris, France. benoit.barrou@psl.ap-hop-paris.fr
Cuzin
Beatrice
B
Malavaud
Bernard
B
Petit
Jacques
J
Pariente
Jean Louis
JL
Buchler
Mathias
M
Cormier
Luc
L
Benoit
Gerard
G
Costa
Pierre
P
D004305:Dose-Response Relationship, Drug; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D005240:Feasibility Studies; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000601:surgery; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011687:Purines; D012449:Safety; D000068677:Sildenafil Citrate; D013450:Sulfones; D016896:Treatment Outcome
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate