Flexible-dose vardenafil in a community-based population of men affected by erectile dysfunction: a 12-week open-label, multicenter trial.
OBJECTIVE
To evaluate the efficacy, safety, and tolerability of a flexible-dose regimen of vardenafil in a community-based population of men with erectile dysfunction (ED).


METHODS
This was a 12-week, open-label, flexible-dose, multicenter study of unselected men with ED of diverse origins and severity. Unlike previous studies, prostatectomy-induced ED and previous unresponsiveness to sildenafil were not exclusion criteria. After 4 weeks of treatment with 10 mg of vardenafil, the dose could be continued or titrated to 5 mg or 20 mg, depending on efficacy and tolerability. After 8 weeks, another dose change was possible. Efficacy was assessed with International Index of Erectile Function erectile function (IIEF-EF) domain scores, diary questions of the Sexual Encounter Profile (SEP), and a global assessment question (GAQ) about erection improvement during the previous 4 weeks.


RESULTS
Safety was evaluated in 497 patients, and 480 were suitable for intention-to-treat analysis. After 12 weeks of treatment, the mean per patient rate of successful intercourse, defined by an affirmative response to SEP questions 1-3, was 72%, and was related to age and ED duration. The overall success rate increased from 66% at week 4 to 77% at week 12. The mean IIEF-EF domain score of the whole population increased from 17.2 (baseline) to 24.4 (endpoint). At week 12, the best scores were obtained by patients taking 5 mg and 10 mg. At week 12, GAQ scores showed improved erection in 97.4%, 94.8%, and 78.8% of patients in the 5 mg, 10 mg, and 20 mg group, respectively. Safety was excellent: no serious drug-related event was reported, and only 2.2% of patients discontinued treatment because of side-effects.


CONCLUSIONS
Vardenafil was effective and well tolerated in this community-based ED population that is truly representative of the general ED population. Dose titration meets the patient's needs and optimizes clinical outcome.
Mirone
Vincenzo
V
University of Naples-Urologic Clinic, Naples, Italy.
Palmieri
Alessandro
A
Cucinotta
Domenico
D
Parazzini
Fabio
F
Morelli
Patrizia
P
Bettocchi
Carlo
C
Fusco
Ferdinando
F
Montorsi
Francesco
F
D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012111:Residence Characteristics; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride