Department of Urology, National Taiwan University Hospital, Taipei, Taiwan.
BJU Int. 2011 Dec;108(11):1843-8. doi: 10.1111/j.1464-410X.2011.10233.x. Epub 2011 May 18.
What's known on the subject? and What does the study add? Silodosin administered by 4 mg twice daily is as effective as tamsulosin 0.2 mg daily in treating patients with LUTS associated with BPH. Relative to tamsulosin, silodosin has less cardiovascular side effects as judged by the minimal changes of blood pressure and pulse rats after treatment.
• To test the hypothesis that the efficacy of silodosin would not be inferior to tamsulosin in treating patients with lower urinary tract symptoms associated with benign prostate hyperplasia (BPH).
• At nine medical centres, 209 patients with an International Prostate Symptom Score (IPSS) of ≥13 were randomized to silodosin (4 mg twice daily) or tamsulosin (0.2 mg once daily) for 12 weeks. • The primary efficacy measure was the mean change from baseline to endpoint in IPSS. • The non-inferiority margin of the IPSS change was set at 1.0. • Secondary efficacy measures included change in maximal urinary flow rate (Q(max)) and health-related quality of life (HRQL) score.
• Of the 170 (81.3%) patients who completed the study, 86.2% in the silodosin group vs 81.9% in the tamsulosin group achieved a ≥25% decrease in IPSS (P= 0.53). • The mean difference (silodosin minus tamsulosin) in IPSS change from baseline was -0.60 (95% confidence interval -2.15, 0.95), inferring the non-inferiority of silodosin to tamsulosin. • The mean changes in the Q(max) and HRQL score from baseline were comparable between the groups (both, P > 0.05). Although patients receiving silodosin had a significantly higher incidence of abnormal ejaculation (9.7% vs tamsulosin 1.0%, P= 0.009), only 1.9% discontinued treatment. • Tamsulosin treatment resulted in a significant reduction in mean systolic blood pressure (-4.2 mmHg, within-group P= 0.004) relative to the negligible change of silodosin (-0.1 mmHg, within-group P= 0.96)
• The trial shows the non-inferiority of silodosin 4 mg twice daily to tamsulosin 0.2 mg once daily in patients with symptoms of BPH.
•检验假设，即与良性前列腺增生（BPH）相关的下尿路症状患者接受西洛多辛治疗的疗效不劣于坦索罗辛。
•在 9 家医疗中心，209 名国际前列腺症状评分（IPSS）≥13 的患者被随机分为西洛多辛（4mg，每日 2 次）或坦索罗辛（0.2mg，每日 1 次）组，治疗 12 周。•主要疗效指标为 IPSS 自基线至终点的平均变化。•IPSS 变化的非劣效性边界设定为 1.0。•次要疗效指标包括最大尿流率（Qmax）和健康相关生活质量（HRQL）评分的变化。
•170 名（81.3%）完成研究的患者中，西洛多辛组 86.2%和坦索罗辛组 81.9%达到 IPSS 降低≥25%（P=0.53）。•自基线的 IPSS 变化的平均差值（西洛多辛减去坦索罗辛）为-0.60（95%置信区间-2.15，0.95），表明西洛多辛与坦索罗辛相比具有非劣效性。•两组的 Qmax 和 HRQL 评分自基线的变化相当（均 P＞0.05）。尽管接受西洛多辛治疗的患者异常射精发生率显著升高（9.7%比坦索罗辛组 1.0%，P=0.009），但只有 1.9%的患者停止治疗。•与西洛多辛组（0.1mmHg，组内 P=0.96）相比，坦索罗辛治疗导致平均收缩压显著降低（-4.2mmHg，组内 P=0.004）。
•该试验表明，西洛多辛 4mg，每日 2 次与坦索罗辛 0.2mg，每日 1 次治疗 BPH 相关症状的患者疗效相当。
