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MINIMAL
CLINICALLY
IMPORTANT
DIFFERENCES
(MCIDs)
IMPROVEMENT OF THE IIEF-ERECTILE FUNCTION DOMAIN IS A PROXY
OF PATIENT WEANING FROM TADALAFIL OaD IN MEN WITH
PSYCHOGENIC ERECTILE DYSFUNCTION – REALISTIC PICTURE FROM
THE EVERYDAY CLINICAL PRACTICE
OBJECTIVES. Assess efficacy, treatment satisfaction and erectile function
(EF) confidence in a cohort of patients with pure psychogenic erectile
dysfunction (ED) treated with tadalafil 5mg once daily (OaD).
METHODS. Data from 100 consecutive patients seeking first medical help for
pure psychogenic ED throughout the last 24 months were analysed. Healthsignificant comorbidities were scored with the Charlson Comorbidity Index
(CCI). Tadalafil 5mg OaD was prescribed to all patients for not less than 6
months. Patients completed a baseline IIEF before therapy and at survey.
Patients were requested to complete a non-validated questionnaire assessing
compliance to and subjective satisfaction over the prescribed therapy.
Descriptive statistics and logistic regression models tested patients compliance
to and efficacy of long-term treatment with tadalafil OaD [also considering
MCIDs criteria].
RESULTS. Patients mean (SD) age was 45.3 (11.9) yrs (range: 21-54). Of all,
30 (30%) patients refused to answer at the survey. Of the remaining 70
patients, 57 (57%) did use the treatment as prescribed, while 13 (13%) patients
did not even start the therapy. Thirty (52.6%) of the total amount of patients
taking tadalafil OaD discontinued the therapy at the end of the first 6 months
course; conversely, 27 (47.4%) kept taking the drug over the prescribed course.
Mean IIEF-EF significantly improved for both groups at FU evaluation
(p<0.001). Overall, 32 (60.4%) patients showed a significant improvement also
according to MCIDs criteria. Of those patients who took tadalafil OaD 34 (63%)
thought to be able to get successful erections dismissing tadalafil OaD at some
point throughout the course of therapy, even with 15 (45.5%) who considered
that option after 1 month since therapy began. Younger (≤40 yrs) and healthier
patients (CCI<1) thought more often to may dismiss the therapy during
treatment (chi2 4.0; p<0.05; chi2 4.191;p=0.04). Conversely baseline IIEF-EF
did not influence patient behaviour over treatment drop-off. At multivariate
analysis, EF improvement according to MCIDs criteria was significantly
associated with patient’s subjective feeling of independence from tadalafil OaD
(OR 6.7; p=0.01).
DISCUSSION. Several studies showed high drop-out rates from PDE5is
therapy ranging between 45% and 78% after 6–24 months. The only positive
reason for discontinuing PDE5is is considered EF recovery. In this context our
findings showed that tadalafil OaD significantly improved EF of patients with
psychogenic ED. Of all, 63% of patients were confident of having full erections
after drug discontinuation. Conversely, almost half of them did not discontinue
the therapy after the first prescription of 6 months. MCID improvements of EF
domain was the only independent factor associated with patient’s confidence in
discontinuing therapy.
CONCLUSIONS. MCIDs improvement of IIEF-EF was a proxy of patient
weaning from tadalafil OaD continuous treatment.