Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study.
Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study.
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DOI：
10.1007/s00345-022-04163-4
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发表时间：
2022-11
影响因子：
3.4
通讯作者：
Yamaguchi, Osamu
中科院分区：
文献类型：
--
作者：
Yoshida, Masaki;Gotoh, Momokazu;Yokoyama, Osamu;Kakizaki, Hidehiro;Yamanishi, Tomonori;Yamaguchi, Osamu
这项多中心、随机、双盲、安慰剂对照的第二阶段研究评估了TAC-302的有效性和安全性，TAC-302是一种恢复轴突生长的新药，用于治疗逼尿肌活动不足(DU)和膀胱过度活动(OAB)的患者。经过2-4周的观察，患者被随机分为2：1口服TAC-302 200 mg或安慰剂，每天两次，共12周。主要终点是逼尿肌收缩强度，通过男性的膀胱收缩指数(BCI)和女性的投影等容压力1(PIP1)来估计。次要终点包括膀胱排尿效率(BVE)和安全性的变化。共纳入76例患者(TAC302例，n = 52例；安慰剂n = 24例)。男性的平均(标准差)BCI在基线时为64.6(16.6)，在12周时(p <； 0.001)为75.2(21.1)，服用TAC-30 2(n = 2 7)时为6 1.3(16.6)和6 0.5(16.7)(p = 0.82)，安慰剂(n = 11)为61.3(16.6)和6 0.5(16.7)(p = 0.82)。女性的平均(SD)PIP1分别为18.8(6.6)和29.4(9.4)(p <； 0.001)，TAC302(n = 15)和安慰剂(n = 7)分别为20.6(7.5)和25.5(9.6)(p = 0.14)。TAC-302显著增加了男性的BCI和两性的BVE。TAC-302对OAB的疗效不明显。不良事件(AEs)、严重AEs和导致用药中断的AEs的发生率在组间相似；未发生药物不良反应。考虑到对男性BCI和BVE的显著影响，TAC-302可能对DU患者有利。ClinicalTrials.gov标识符NCT03175029已于2017年6月5日注册。网上版载有补充材料，可在10.1007/s00345-022-04163-4查阅。
This multicenter, randomized, double-blind, placebo-controlled phase 2 study evaluated the efficacy and safety of TAC-302, a novel drug that restores neurite outgrowth, in patients with detrusor underactivity (DU) and overactive bladder (OAB). After 2–4 weeks of observation, patients were randomized 2:1 to receive oral TAC-302 200 mg or placebo twice daily for 12 weeks. The primary endpoint was detrusor contraction strength, estimated by bladder contractility index (BCI) for males and projected isovolumetric pressure 1 (PIP1) for females. Secondary endpoints included changes in bladder voiding efficiency (BVE) and safety. Seventy-six patients were included (TAC-302, n = 52; placebo, n = 24). The mean (standard deviation [SD]) BCI for males was 64.6 (16.6) at baseline and 75.2 (21.1) at week 12 (p < 0.001) with TAC-302 (n = 27), and 61.3 (16.6) and 60.5 (16.7) (p = 0.82) with placebo (n = 11). The respective mean (SD) PIP1 for females was 18.8 (6.6) and 29.4 (9.4) (p < 0.001) with TAC-302 (n = 15), and 20.6 (7.5) and 25.5 (9.6) (p = 0.14) with placebo (n = 7). TAC-302 significantly increased BCI in males and BVE in both sexes. TAC-302 efficacy on OAB was not clearly shown. The incidences of adverse events (AEs), serious AEs, and AEs leading to dose interruption were similar between groups; no adverse drug reactions occurred. Considering the significant effects on BCI in males and BVE in both sexes, TAC-302 may benefit patients with DU. ClinicalTrials.gov Identifier NCT03175029 registered 6/5/2017. The online version contains supplementary material available at 10.1007/s00345-022-04163-4.
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