OBJECTIVES Our objective was to investigate the effectiveness and safety of silodosin in patients with benign prostatic hyperplasia (BPH) who switched to silodosin from another α1 blocker because of inadequate response. METHODS This was a prospective observational study conducted at 715 medical facilities in Japan in patients with BPH who received an α1 blocker other than silodosin for at least 3 months but had experienced unsatisfactory treatment outcomes. Patients completed questionnaires, including the International Prostate Symptom Score (IPSS), quality of life (QOL) score and Overactive Bladder Symptom Score (OABSS) at baseline (time of switching) and after 3 months of treatment with silodosin. RESULTS Overall, 3355 patients were assessed for safety and 3144 patients for effectiveness. Mean ± standard deviation age was 73.1 ± 8.2 years, and most patients had been receiving tamsulosin (53.6%) or naftopidil (45.5%) before silodosin. Silodosin was well tolerated, with an overall incidence of adverse drug reactions of 8.1% and no unexpected safety signals. Significant improvements were observed after switching to silodosin in all effectiveness outcome measures, including total IPSS, all IPSS subscale scores, QOL score, total OABSS, all OABSS subscale scores and residual urine volume. Significant improvements in total IPSS were seen in patients who had been receiving tamsulosin or naftopidil before switching and in almost all other patient subgroups, with the exception of patients with mild symptoms (total IPSS ≤ 7) at baseline. CONCLUSIONS This post-marketing analysis indicates that switching to silodosin from tamsulosin or naftopidil significantly improved symptoms associated with BPH, and silodosin was well tolerated in Japanese patients.

中文翻译：

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西洛多辛对良性前列腺增生和对现有α-1受体阻滞剂反应不良的患者的上市后监测：SPLASH研究。

目的我们的目的是研究西洛多辛在良性前列腺增生（BPH）患者中的疗效和安全性，该患者由于反应不足而从另一种α1受体阻滞剂转为西洛多辛。方法这是一项前瞻性观察性研究，在日本的715家医疗机构中对BPH接受了西洛多辛以外的α1受体阻滞剂至少3个月但治疗效果不理想的BPH患者进行了观察性研究。患者完成了问卷调查，包括国际前列腺症状评分（IPSS），生活质量（QOL）评分和基线（转换时间）以及西洛多辛治疗3个月后膀胱过度活动症症状评分（OABSS）。结果总体上，对3355例患者进行了安全性评估，对3144例患者进行了有效性评估。平均±标准差年龄为73.1±8.2岁，大多数患者在接受西洛多辛之前已接受坦索罗辛（53.6％）或那夫多地（45.5％）。西洛多辛具有良好的耐受性，药物不良反应的总发生率为8.1％，并且没有意外的安全信号。切换至西洛多辛后，所有有效结局指标均得到了显着改善，包括总IPSS，所有IPSS子评分，QOL评分，总OABSS，所有OABSS子评分和残留尿量。除基线时有轻度症状（总IPSS≤7）的患者外，在转换前接受坦索罗辛或那夫多地的患者以及几乎所有其他患者亚组中，总IPSS均有显着改善。