Department of Urology, University of Texas (UT) Southwestern Medical Center, Dallas, TX, USA.
GlaxoSmithKline (GSK), Washington, DC, USA.
BJU Int. 2018 Apr;121(4):647-658. doi: 10.1111/bju.14057. Epub 2017 Nov 16.
To prospectively assess the impact of the fixed-dose combination (FDC) of the 5α-reductase inhibitor (5ARI), dutasteride 0.5 mg and the α -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).
This European and Australian double-blind, placebo-controlled, parallel-group study was conducted at 51 centres.
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.
前瞻性评估 5α-还原酶抑制剂（5ARI）与 α-肾上腺素能拮抗剂固定剂量组合（FDC），即 dutasteride 0.5mg 和 tamsulosin 0.4mg（DUT-TAM FDC）治疗对良性前列腺增生（BPH）继发下尿路症状（LUTS）男性性功能领域评分的影响，采用男性健康调查问卷（MSHQ）。
这是一项在 51 个中心进行的欧洲和澳大利亚双盲、安慰剂对照、平行组研究。
年龄≥50 岁，国际前列腺症状评分≥12，前列腺体积≥30cc，前列腺特异性抗原 1.5-10ng/ml。患者按 1:1 随机分为 DUT-TAM FDC 治疗组或安慰剂组，治疗 12 个月。采用混合模型重复测量分析评估从基线到第 12 个月的总 MSHQ（主要终点）和 MSHQ 勃起、射精和满意度领域（次要终点）的变化。评估安全性。
意向治疗人群包括 489 例患者（DUT-TAM FDC 治疗 243 例，安慰剂 246 例）。与安慰剂相比，DUT-TAM FDC 治疗组在总 MSHQ 评分上出现显著下降（恶化）（-8.7 对-0.7；标准误 [se]：0.81，0.78；P＜0.001），以及射精（-7.5 对-0.6；se：0.56，0.55；P＜0.001）和满意度（-0.6 对+0.3；se：0.3，0.29，P=0.047）领域，但勃起领域无变化（-1.0 对-0.5；se：0.19，0.19，P=0.091）。
这是首次对 5ARI 治疗 BPH 继发 LUTS 男性性功能进行特定领域的定量评估。DUT-TAM FDC 治疗后 MSHQ 观察到的变化主要是由射精领域的变化驱动的。这些发现将有助于理解早期 5ARI 研究中自发报告的勃起和射精功能障碍不良事件。
