Initiation of ED treatment with a particular PDE5I may influence treatment-adherence and other outcomes.
In this multicenter, open-label study, men with ED, naïve to PDE5I, were randomized to tadalafil 5 mg once-a-day (OaD; N=257), 10 mg on demand (PRN; N=252) or sildenafil-citrate (sildenafil) 50 mg PRN (N=261) for 8 weeks (dose adjustments allowed), followed by 16 weeks of pragmatic treatment (switching between PDE5I allowed). Primary outcomes (treatment-adherence) were reported previously. Here, we report effects on: Psychological and Interpersonal Relationship Scales, Self-Esteem and Relationship (SEAR) questionnaire, ED Inventory of Treatment Satisfaction (EDITS), International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) and Global Assessment Questions (GAQ). Mixed-model for repeated measures and analysis of covariance were used to analyze changes from baseline; GAQ-responses were evaluated by logistic regression. Analyses were adjusted for treatment, country, ED-severity, baseline and baseline-by-treatment interaction. Patients randomized to tadalafil OaD or PRN reported greater improvement (least-square mean (s.e.) change) in Sexual Self-Confidence (OaD +0.90 (0.048), PRN +0.93 (0.050), vs +0.73 (0.049); P=0.006 and P=0.001) and Spontaneity (OaD +0.11 (0.035), PRN +0.13 (0.035), vs +0.02 (0.035); P=0.044 and P=0.010) compared with sildenafil. Improvements in GAQ and SEP responses, IIEF-EF, orgasmic function, sexual desire, overall satisfaction domains, SEAR and EDITS scores did not differ significantly between treatment groups.
Written by:
Hatzimouratidis K, Buvat J, Büttner H, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Are you the author?
2nd Department of Urology, Aristotle University of Thessaloniki, Thessaloniki, Greece; Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France; Lilly Deutschland GmbH, Medical Department, Bad Homburg, Germany; Saúde Atlântica, Clínica do Dragão, Porto, Portugal; Department of Urology, Hospital La Zarzuela, Madrid, Spain; Diabetological Practice, Warburg, Germany; Lilly Deutschland GmbH, Global Statistical Sciences, Bad Homburg, Germany.
Reference: Int J Impot Res. 2014 May 1. Epub ahead of print.
doi: 10.1038/ijir.2014.15
PubMed Abstract
PMID: 24784894
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