An evaluation of an alternative dosing regimen with tadalafil, 3 times/week, for men with erectile dysfunction: SURE study in 14 European countries.
OBJECTIVE
To examine the preference for 2 dosing regimens (on demand or 3 times/week) for tadalafil, a phosphodiesterase 5 inhibitor with a duration of effectiveness up to 36 hours in men with erectile dysfunction (ED).


METHODS
SURE is a 14 European country, multicenter, crossover, and open-label study. Men with ED (N=4262) were randomized to tadalafil 20mg treatment on demand (maximum one dose per day and before sexual activity) or 3 times/week for 5-6 weeks. After a 1-week washout period, patients were crossed over to the alternate regimen for 5-6 weeks. The patient's response to a treatment preference question (TPQ) was used to determine the preferred treatment regimen.


RESULTS
The mean age of the randomized patients was 55 years and 85.2% reported a history of ED for one year or greater. Overall, the responses of 3861 men to the TPQ assessment showed that 57.8% preferred the on-demand regimen and 42.2% preferred the 3 times/week dosing. Both regimens were efficacious and well tolerated.


CONCLUSIONS
In this study, while 57.8% of men preferred the on-demand regimen of tadalafil 20mg, a substantial number (42.2%) preferred the 3 times/week treatment. The two regimens provide additional treatment options by giving men with erectile dysfunction unique flexibility in dosing with tadalafil.
Mirone
Vincenzo
V
University of Naples Federico II, A.O.U. Federico II, Via S. Pansini 5, Ed. 5-80131, Napoli, Italy. mirone@unina.it
Costa
Pierre
P
Damber
Jan-Erik
JE
Holmes
Simon
S
Moncada
Ignacio
I
Van Ahlen
Hermann
H
Wespes
Eric
E
Cordell
William H
WH
Chan
Melanie
M
Lembo
Danilo
D
Varanese
Lucio
L
D002243:Carbolines / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D005060:Europe; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D012189:Retrospective Studies; D012449:Safety; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil