Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study.
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.
2nd Department of Urology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
K
K
Hatzimouratidis
Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France.
J
J
Buvat
Lilly Deutschland GmbH, Medical Department, Bad Homburg, Germany.
H
H
Büttner
Saúde Atlântica, Clínica do Dragão, Porto, Portugal.
P A S
PA
Vendeira
Department of Urology, Hospital La Zarzuela, Madrid, Spain.
I
I
Moncada
Diabetological Practice, Warburg, Germany.
M
M
Boehmer
Lilly Deutschland GmbH, Global Statistical Sciences, Bad Homburg, Germany.
C
C
Henneges
Lilly Deutschland GmbH, Medical Department, Bad Homburg, Germany.
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FG
Boess
D000368:Aged; D002243:Carbolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000523:psychology*; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011687:Purines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012649:Self Concept; D012720:Severity of Illness Index; D000068677:Sildenafil Citrate; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013449:Sulfonamides; D000068581:Tadalafil; D000068677:Sildenafil Citrate