Department of Surgery, Urology Division, "San Salvatore" General Hospital, L'Aquila, Italy.
Eur Rev Med Pharmacol Sci. 2017 Nov;21(21):4941-4945.
Lower urinary tract symptoms (LUTS) are frequently experienced in association with benign prostatic enlargement (BPE). Current guidelines state that alpha-blockers should be considered the first-line therapy of LUTS associated with BPE in most patients. However, in clinical practice treatment efficacy differs among individuals and, therefore, intra-class switch from one alpha-blocker to another, is frequently applied. In particular, switching to silodosin in clinical practice appears an intriguing therapeutic strategy due to the peculiar pharmacological properties of this molecule. This study evaluates the efficacy of silodosin in patients with LUTS associated with BPE who were not-responders to tamsulosin.
This was a prospective, open-label, single-center study. Patients treated with tamsulosin 0.4 mg once daily for BPE/LUTS for at least 12 months and not responding to therapy were switched to silodosin 8 mg once daily. The co-primary endpoints for evaluation of efficacy were the change in IPSS and quality of life (QoL) from the beginning of silodosin therapy to week 8.
In total, 96 patients were enrolled. Mean International Prostatic Symptoms Score (IPSS) score at baseline was 20.0 ± 4.4, and it significantly decreased to 18.6 ± 4.5 at week 8 (mean change: -1.3 ± 1.4; 95% CI -1.6 - -1.0; p < 0.03). A decrease was also observed for the two IPSS subscores; in particular, the IPSS subscore for storage symptoms was significantly reduced at week 8, compared with baseline. A significant improvement in QoL was observed after switching to silodosin, as compared with baseline (-0.8 ± 1.0; 95% CI -1.0 - -0.6; p < 0.001).
Silodosin improves IPSS symptoms score and QoL in patients with LUTS associated with BPE who were not-responders to tamsulosin therapy.
下尿路症状（LUTS）常与良性前列腺增生（BPE）相关。目前的指南指出，在大多数患者中，α受体阻滞剂应被视为与 BPE 相关的 LUTS 的一线治疗方法。然而，在临床实践中，个体之间的治疗效果存在差异，因此，经常会进行同类药物之间的转换。特别是，由于这种分子的特殊药理学特性，在临床实践中转换为西洛多辛似乎是一种有趣的治疗策略。本研究评估了西洛多辛在对坦索罗辛治疗无反应的 BPE/LUTS 患者中的疗效。
这是一项前瞻性、开放标签、单中心研究。接受坦索罗辛 0.4mg 每日一次治疗 BPE/LUTS 至少 12 个月且对治疗无反应的患者转换为西洛多辛 8mg 每日一次。评估疗效的主要终点是从西洛多辛治疗开始到第 8 周时 IPSS 和生活质量（QoL）的变化。
共有 96 名患者入组。基线时平均国际前列腺症状评分（IPSS）为 20.0±4.4，第 8 周时显著降至 18.6±4.5（平均变化：-1.3±1.4；95%CI-1.6-1.0；p<0.03）。两个 IPSS 子评分也有所下降；特别是，与基线相比，存储症状的 IPSS 子评分在第 8 周时显著降低。与基线相比，转换为西洛多辛后 QoL 显著改善（-0.8±1.0；95%CI-1.0-0.6；p<0.001）。
西洛多辛可改善对坦索罗辛治疗无反应的 BPE 相关 LUTS 患者的 IPSS 症状评分和生活质量。
