Asahikawa Medical University, Asahikawa, Japan.
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Adv Ther. 2021 Jan;38(1):739-757. doi: 10.1007/s12325-020-01517-5. Epub 2020 Nov 27.
MATCH was a randomized, double-blind, placebo-controlled study enrolling Japanese and Korean men aged ≥ 40 years who still had overactive bladder (OAB) symptoms while receiving tamsulosin. After a 4-week single-blind screening period in which patients received placebo and tamsulosin, patients were randomized to mirabegron 50 mg + tamsulosin or placebo + tamsulosin for 12 weeks (n = 568). This post hoc analysis investigated the proportion of treatment responders for each treatment group and for subgroups stratified by age based on voiding diaries and patient-reported outcomes (PROs).
Responders were defined as those achieving normalization or clinically meaningful improvements in efficacy, or clinically important differences in PROs [≥ 10-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by ≥ 3 points at EoT [minimally clinically important change (MCIC)]].
At EoT, micturition frequency normalization was achieved by 30.7% of tamsulosin + mirabegron patients and 18.6% of tamsulosin + placebo patients. Normalization of urgency and incontinence was 19.1% and 60.7% for tamsulosin + mirabegron and 18.2% and 60.0% for tamsulosin + placebo. Normalization of OAB symptoms based on OABSS was 17.1% for tamsulosin + mirabegron and 14.5% for tamsulosin + placebo. Higher proportions of patients in the mirabegron add-on group versus the placebo group reported clinically meaningful improvements in micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales. Double- and triple-responder findings were as predicted by the results of single-responder analyses. These results were mirrored in the age groups using cut-offs of 65 and 75 years.
Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS).
ClinicalTrials.gov identifier, NCT02656173.
MATCH 是一项随机、双盲、安慰剂对照的研究，纳入了年龄≥40 岁的日本和韩国男性，他们在接受坦索罗辛治疗时仍有膀胱过度活动症（OAB）症状。在为期 4 周的单盲筛选期内，患者接受安慰剂和坦索罗辛治疗，然后随机分为米拉贝隆 50mg+坦索罗辛或安慰剂+坦索罗辛治疗 12 周（n=568）。本事后分析调查了每组治疗的应答者比例，以及根据排尿日记和患者报告的结果（PROs）按年龄分层的亚组的应答者比例。
应答者定义为在疗效方面达到正常化或具有临床意义的改善，或在 PROs 方面具有临床重要差异[在治疗结束时（EoT）OAB 问卷（OAB-q）症状困扰或总健康相关生活质量（HRQoL）子量表至少改善 10 点（最小有意义差异[MID]）或 OAB 症状评分（OABSS）总分在 EoT 时降低≥3 点（最小临床重要变化[MCIC]）]。
在 EoT 时，坦索罗辛+米拉贝隆组有 30.7%的患者达到排尿频率正常化，坦索罗辛+安慰剂组有 18.6%的患者达到排尿频率正常化。坦索罗辛+米拉贝隆组有 19.1%和 60.7%的患者达到急迫性和尿失禁正常化，坦索罗辛+安慰剂组有 18.2%和 60.0%的患者达到急迫性和尿失禁正常化。基于 OABSS 的 OAB 症状正常化比例，坦索罗辛+米拉贝隆组为 17.1%，坦索罗辛+安慰剂组为 14.5%。与安慰剂组相比，米拉贝隆附加组有更高比例的患者报告在排尿、急迫性和尿失禁方面具有临床意义的改善，并且在 OABSS 的 MCIC 和 OAB-q 子量表的 MID 方面具有临床意义的改善。双重和三重应答者的发现与单一应答者分析的结果一致。这些结果在使用 65 岁和 75 岁年龄截点的年龄组中得到了反映。
米拉贝隆联合坦索罗辛治疗可使更多患者在正常化（例如排尿频率正常化）、疗效方面具有临床意义的改善（例如，急迫性降低≥50%）和 PROs 方面具有微小的重要变化（例如，OABSS 的 MCIC）方面具有更高的应答率。
ClinicalTrials.gov 标识符，NCT02656173。
