Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors.
Previous studies established the efficacy of once-daily tadalafil for men  with erectile dysfunction. However, no trial has focused on the effects of  such treatment on men without previous experience using oral phosphodiesterase  type 5 inhibitors. Patients were randomized (2:1) to once-daily tadalafil 5 mg  (with possible down-titration to 2.5 mg; n = 146) or placebo (n = 69) for 12  weeks. Among 215 patients (mean age, 52 years), once-daily tadalafil treatment  resulted in 61.7% of study participants reporting their ability to achieve and  maintain erections as being much better or very much better (vs 21.7% on  placebo; P < .001). Tadalafil significantly improved treatment  satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction  (P < .001 vs placebo at end point) and psychosocial outcomes on  the Self-Esteem and Relationship (SEAR) questionnaire (least squares mean  difference in SEAR total score change from baseline, 11.8 [95% confidence  interval, 5.4%-18.2%; P < .001 vs placebo]). Patients  receiving once-daily tadalafil also experienced a higher proportion of daily  self-reported spontaneous morning erections at end point (58.7%) compared with  placebo (42.2%; P < .001 for the between-treatment difference in  changes from baseline). However, no significant differences in parameters of  endothelial dysfunction (including biomarkers and peripheral arterial  tonometric measures) or nocturnal erections as recorded by the nocturnal  electrobioimpedance volumetric assessment were observed between treatment  groups. Tadalafil was well tolerated; adverse events included back pain,  headache, and dyspepsia. These findings may contribute to a more comprehensive  understanding of once-daily tadalafil's effects on phosphodiesterase type 5  inhibitor-naive men.
Private Practice of Urology and Andrology, Neuer Jungfernstieg 6a, 20354 Hamburg, Germany. Porst20354@aol.com
Hartmut
H
Porst
Gerald B
GB
Brock
Krzysztof
K
Kula
Ignacio
I
Moncada
Francesco
F
Montorsi
Bruce R
BR
Basson
Kraig
K
Kinchen
Antonio
A
Aversa
D000328:Adult; D002243:Carbolines / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004730:Endothelium, Vascular / Q000502:physiology; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D006940:Hyperemia / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects / Q000502:physiology; D010549:Personal Satisfaction; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D010919:Placebos; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D010919:Placebos; D000068581:Tadalafil