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VARDENAFIL ODT PROMOTES A SATISFACTORY ERECTION IN LESS
THAN 30 MINUTES IN ONE PATIENT OUT OF THREE – REALISTIC
PICTURE FROM THE EVERYDAY CLINICAL PRACTICE
OBJECTIVES. We sought to assess efficacy rate and time to onset of action of
vardenafil 10mg ODT in sexually active heterosexual men (either naive or not
for phosphodiesterase type 5 inhibitors – PDE5i) seeking medical help for
erectile dysfunction (ED) in the everyday clinical practice.
METHODS. Sociodemographic and clinical data from the last 100 consecutive
patients treated with vardenafil ODT were analysed. Health-significant
comorbidities were scored with the Charlson Comorbidity Index (CCI) as a
continuous or a categorized variable (0 vs 1 vs ≥2). Categorized measured
body mass index (BMI) cut-offs were used as proposed by the NIH. All patients
completed the International Index of Erectile Function (IIEF) domains at
baseline and at survey. ED severity was stratified according to the IIEF-erectile
function (IIEF-EF) domain scores. Descriptive statistics and logistic regression
models tested the association between vardenafil ODT treatment and potential
predictors.
RESULTS. Of all, 61 (61%), 32 (32%), and 7 (7%) patients did use, did never
start, and did not agree to participate to the survey, respectively. No significant
differences were observed among men who have taken the drug as compared
with those who did not in terms of age, educational and relationship status;
conversely, more patients who have been previously treated with PDE5i did
use vardenafil ODT (2: 14.64; p=0.001). Vardenafil ODT was taken 2 hours,
between 1 and 2 hours, <1 hour, and  30 min by 7 (11.5%), 13 (21%), 18
(29.5%), and 23 (38%) of the patients. An erection sufficiently rigid for vaginal
penetration was reported in 5 (8.2%), 5 (8.2%), 11 (18%), 14 (23%), 10
(16.3%), and 16 (26.3%) of the patients in <15 min, < 20 min, < 30 min, < 45
min, < 60 min, and  2 hours, respectively. All IIEF-domain scores were
significantly improved after vardenafil ODT (all p0.004). Of 61, 48 (78.7%) had
a positive SEP3 response. At multivariate logistic regression models, BMI > 25
emerged as the only independent predictor of delayed onset of action after
vardenafil ODT intake.
DISCUSSION. Time to onset of action has a significant impact over patients’
compliance to PDE5i therapy. In this real life cross-sectional study we
investigated time to onset of action of the PDE5i firstly available in ODT
formulation and we found that 34.4 % of patients taking vardenafil 10mg ODT
had a satisfactory erection in less than 30 min after drug intake.
CONCLUSIONS. One out of three ED patients taking vardenafil ODT reports a
satisfactory erection in less than 30 min after drug intake in the real-life setting.