Haque Nazneen, Masumori Naoya, Sakamoto Sadaaki, Ye Zhangqun, Yoon Sang-Jin, Kuo Hann-Chorng, Brotherton Betsy, Wilson Timothy, Muganurmath Chandra, McLaughlin Megan, Manyak Michael
GlaxoSmithKline, Brentford, Middlesex, UK.
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan.
Int J Urol. 2018 Nov;25(11):944-951. doi: 10.1111/iju.13785. Epub 2018 Sep 9.
To assess the effectiveness and safety of dutasteride 0.5 mg + tamsulosin 0.2 mg combination compared with tamsulosin 0.2 mg in Asian men with moderate-to-severe benign prostatic hyperplasia.
A 4-week, single-blind, placebo, run-in was followed by a 2-year double-blind randomized controlled trial in men age ≥50 years with symptomatic benign prostatic hyperplasia, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen ≥1.5 and ≤10 ng/mL, peak urinary flow >5 and ≤15 mL/s, and voided volume of ≥125 mL. Participants were randomized to oral daily dutasteride 0.5 mg + tamsulosin 0.2 mg combination or tamsulosin 0.2 mg. The primary efficacy end-point was change in International Prostate Symptom Score at year 2.
Data from 607 participants showed a significant reduction in International Prostate Symptom Score (P < 0.05) at month 24, along with greater improvements (P ≤ 0.006) in peak urinary flow at every assessment and significant prostate volume reduction at months 12 and 24 (P < 0.001) in the combination group. Combination therapy was associated with a significant reduction in the risk of acute urinary retention or benign prostatic hyperplasia-related surgery (P = 0.012), primarily due to a significant reduction in the risk of acute urinary retention (P = 0.005). The safety and tolerability profile of combination therapy was consistent with the known profiles for the individual monotherapies.
Dutasteride 0.5 mg + tamsulosin 0.2 mg combination therapy showed better clinical outcomes than tamsulosin 0.2 mg monotherapy, making it an effective and safe treatment option for Asian men with moderate-to-severe benign prostatic hyperplasia.
评估0.5毫克度他雄胺与0.2毫克坦索罗辛联合用药相较于0.2毫克坦索罗辛单药治疗对亚洲中重度良性前列腺增生男性患者的有效性和安全性。
对年龄≥50岁、有症状的良性前列腺增生、国际前列腺症状评分≥12、前列腺体积≥30立方厘米、前列腺特异性抗原≥1.5且≤10纳克/毫升、最大尿流率>5且≤15毫升/秒、排尿量≥125毫升的男性进行为期4周的单盲、安慰剂导入期，随后进行为期2年的双盲随机对照试验。参与者被随机分为每日口服0.5毫克度他雄胺与0.2毫克坦索罗辛联合用药组或0.2毫克坦索罗辛单药组。主要疗效终点是第2年时国际前列腺症状评分的变化。
607名参与者的数据显示，联合用药组在第24个月时国际前列腺症状评分显著降低（P<0.05），每次评估时最大尿流率改善更明显（P≤0.006），在第12个月和第24个月时前列腺体积显著缩小（P<0.001）。联合治疗与急性尿潴留或良性前列腺增生相关手术风险显著降低相关（P = 0.012），主要是由于急性尿潴留风险显著降低（P = 0.005）。联合治疗的安全性和耐受性与已知的各单药治疗情况一致。
0.5毫克度他雄胺与0.2毫克坦索罗辛联合治疗比0.2毫克坦索罗辛单药治疗显示出更好的临床效果，使其成为亚洲中重度良性前列腺增生男性患者有效且安全的治疗选择。
