Abstract | INTRODUCTION: AIM: Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED). METHODS: A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5 mg or PBO once daily coadministered with FIN 5 mg once daily for 26 weeks. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs). RESULTS: Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P ≤ 0.002 for all measures) and among patients without baseline ED (P ≤ 0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P < 0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3 three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders. CONCLUSIONS: TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.
|
Authors | Sidney Glina, Claus G Roehrborn, Adil Esen, Alexey Plekhanov, Sebastian Sorsaburu, Carsten Henneges, Hartwig Büttner, Lars Viktrup |
Journal | The journal of sexual medicine
(J Sex Med)
Vol. 12
Issue 1
Pg. 129-38
(Jan 2015)
ISSN: 1743-6109 [Electronic] Netherlands |
PMID | 25353053
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | © 2014 International Society for Sexual Medicine. |
Chemical References |
- Carbolines
- Phosphodiesterase 5 Inhibitors
- Finasteride
- Tadalafil
|
Topics |
- Carbolines
(therapeutic use)
- Coitus
- Comorbidity
- Double-Blind Method
- Drug Therapy, Combination
- Erectile Dysfunction
(drug therapy, etiology, physiopathology)
- Finasteride
(therapeutic use)
- Humans
- Lower Urinary Tract Symptoms
(complications, drug therapy, physiopathology)
- Male
- Middle Aged
- Phosphodiesterase 5 Inhibitors
(therapeutic use)
- Prostatic Hyperplasia
(complications, drug therapy, physiopathology)
- Tadalafil
- Treatment Outcome
|