Sexual Function in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia: Results of a 6-Month, Randomized, Double-Blind, Placebo-Controlled Study of Tadalafil Coadministered with Finasteride. (1st January 2015)

• Record Type: Journal Article
• Authors: Glina, Sidney; Roehrborn, Claus G.; Esen, Adil; Plekhanov, Alexey; Sorsaburu, Sebastian; Henneges, Carsten; Büttner, Hartwig; Viktrup, Lars
• Is Part Of: Journal of sexual medicine. Volume 12:Number 1(2015:Jan.)
• Page Start: 129
• Page End: 138
• Publication Date: 2015-01-01
• Subjects: 5-Alpha Reductase Inhibitors -- Benign Prostatic Hyperplasia -- Ejaculatory Function -- Erectile Dysfunction -- Finasteride -- Lower Urinary Tract Symptoms -- Orgasmic Function -- Phosphodiesterase Type 5 Inhibitors -- Tadalafil; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1111/jsm.12714
• Languages: English
• ISSNs: 1743-6095

Abstract

ABSTRACT: Introduction: Tadalafil (TAD) 5 mg coadministered with finasteride (FIN) 5 mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described. 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 3three 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.