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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 陳妤甄 | 針對膀胱過動之老年患者 - 評估Mirabegron的療效、安全性和耐受性 (PILLAR Study) | 2021/3/30 下午 07:11:32 | 0 |
| 原 文 | 題 目 | Efficacy, safety, and tolerability of mirabegron in patients aged ≥65yr with overactive bladder wet: a phase IV, double-blind, randomised, placebo-controlled study (PILLAR) |
| 作 者 | Wagg A, Staskin D, Engel E, Herschorn S, Kristy RM, Schermer CR. | |
| 出 處 | European Urology, 2020 Feb;77(2):211-220. | |
| 出版日期 | February, 2020 | |
| 評 論 |
大部分膀胱過動症患者為65歲以上的老年人；此篇文章 (以下簡稱: PILLAR試驗) 是第一個使用β3腎上腺受體促進劑 - Mirabegron藥物進行充分研究以證明Mirabegron對老年患者具有療效和安全性 (包括認知功能) 的研究。
PILLAR試驗為第4期、雙盲、隨機、安慰劑對照的研究 (共103個研究中心)；研究地點橫跨美國和加拿大；本篇研究將年老(65歲以上)膀胱過動症患按1:1的比例隨機分為使用Mirabegron組和安慰劑組，在給予12周的藥物治療後，評估排尿次數、尿失禁發作次數、以及生活品質是否有改善。 研究發現：針對65歲以上的膀胱過動症患者，使用Mirabegron比起安慰劑，可以明顯改善頻尿(降低排尿次數)、改善尿失禁(降低尿失禁發作次數)、增加生活品質(困擾指數下降、生活品質上升)；在安全性方面，Mirabegron的耐受性良好，不良事件特性呈現與Mirabegron的已知特性一致，對認知功能的影響在所有治療組別不具統計學上的意義。 整體而言，使用Mirabegron治療膀胱過動老年症患，可有效改善症狀，安全耐受性已知，可供臨床上治療之使用。 |
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| abstract |
Background: The majority of patients with overactive bladder (OAB) are aged >65yr. There has been no prospectively designed study assessing treatment efficacy with the β3-adrenoreceptor agonist, mirabegron, specifically in this age group.
Objective: A phase IV study comparing flexibly dosed mirabegron versus placebo in elderly patients with OAB and urgency incontinence. Design, setting, and participants: Community-dwelling patients aged ≥65yr with OAB for ≥3mo. Intervention: Following a 2-wk placebo run in, patients with one or more incontinence episodes, three or more urgency episodes, and an average of eight or more micturitions/24h were randomised 1:1 to double-blind 25mg/d mirabegron or matched placebo, for 12wk. After week 4 or 8, the dose could be increased to 50mg/d mirabegron/matched placebo based on patient and investigator discretion. Outcome measurements and statistical analysis: Coprimary endpoints: change from baseline to end of treatment (EOT) in the mean numbers of micturitions/24h and incontinence episodes/24h. Secondary endpoints: change from baseline to EOT in the mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Analysis of covariance (ANCOVA) was used for the mean number of micturitions/24h, mean volume voided/micturition, and mean number of urgency episodes/24h. Stratified rank ANCOVA was used for the mean numbers of incontinence episodes/24h and urgency incontinence episodes/24h. Results and limitations: Statistically significant improvements were observed for mirabegron versus placebo in change from baseline to EOT in the mean number of micturitions/24h, mean number of incontinence episodes/24h, mean volume voided/micturition, mean number of urgency episodes/24h, and mean number of urgency incontinence episodes/24h. Safety and tolerability were consistent with the known mirabegron safety profile. Conclusions: Mirabegron efficacy, safety, and tolerability over 12 wk were confirmed in patients aged ≥65yr with OAB and incontinence. Patient summary: We examined the effect of mirabegron compared with placebo in people aged 65yr or older with overactive bladder and incontinence. Mirabegron improved the symptoms of overactive bladder compared with placebo. Side effects were similar to those already known for mirabegron. |
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