Você está deixando o Portal Médico GSK

Você está prestes a deixar o site da GSK. Ao clicar neste link, você será direcionado a um site que não pertence ou é controlado pela GSK. Portanto, a GSK não é responsável por demais conteúdos presentes neste site.




A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Claus G. Roehrborn, Michael J. Manyak, Juan Manuel Palacios-Moreno , Timothy H. Wilson, Erik P.M. Roos, Javier Cambronero Santos, Dimitrios Karanastasis, Janet Plastino, François Giuliano and Raymond C. Rosen.

BJU Int 2018; 121: 647-658


To prospectively assess the impact of the fixed-dose combination (FDC) of the 5a-reductase inhibitor (5ARI), dutasteride 0.5 mg and the a1-adrenoceptor antagonist, tamsulosin 0.4 mg (DUT-TAM FDC) therapy on sexual function domain scores in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), using the Men’s Sexual Health Questionnaire (MSHQ).

Patients and Methods:

This European and Australian double-blind, placebocontrolled, parallel-group study was conducted at 51 centres. Inclusion criteria: age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen 1.5–10 ng/mL. Patients were randomised 1:1 to DUT-TAM FDC therapy or placebo for 12 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains (secondary outcome) was assessed, using a mixed model repeated measures analysis. Safety was evaluated.


The intention-to-treat population included 489 patients (243 DUT-TAM FDC therapy; 246 placebo). A significant decrease (worsening) was observed with DUT-TAM FDC therapy versus placebo on the total MSHQ score (8.7 vs 0.7; standard error [SE]: 0.81, 0.78; P < 0.001), and the ejaculation (7.5 vs 0.6; SE: 0.56, 0.55; P < 0.001) and satisfaction (0.6 vs +0.3; SE: 0.3, 0.29, P = 0.047) domains, but not the erection domain (1.0 vs 0.5; SE: 0.19, 0.19, P = 0.091).


This is the first domain-specific quantitative evaluation of DUT-TAM FDC therapy on sexual function in men with LUTS secondary to BPH. The observed changes in the MSHQ with DUT-TAM FDC therapy were mainly driven by changes in the ejaculation domain. These findings will help give context to erectile and ejaculatory dysfunction AEs reported spontaneously in earlier 5ARI studies.


Desbloqueie os pop-ups para ter acesso aos serviços. 

Saiba como desbloquear os pop-ups.