Department of Gastroenterology, University of Leuven, Leuven, Belgium.
Texas Tech University, El Paso, Texas, USA.
Neurogastroenterol Motil. 2023 Oct;35(10):e14652. doi: 10.1111/nmo.14652. Epub 2023 Aug 3.
Previous clinical studies of trazpiroben, a dopamine D /D receptor antagonist for long-term treatment of moderate-to-severe idiopathic and diabetic gastroparesis, have shown improved symptoms of fullness. This study assessed trazpiroben efficacy, safety, and tolerability in adults with idiopathic and diabetic gastroparesis versus placebo.
This global, multicenter, double-blind, parallel-group, phase 2b study (NCT03544229) enrolled eligible adults aged 18-85 years with symptomatic idiopathic or diabetic gastroparesis. Randomized participants received either oral placebo or trazpiroben 5, 25, or 50 mg, administered twice daily over 12 weeks, and completed the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary. Change in weekly composite score from baseline to week 12 (primary endpoint) and treatment-emergent adverse events were assessed. Data were summarized descriptively.
Overall, 242 participants were enrolled (mean [standard deviation] age 55.7 [14.2] years; 75.6% female); 193 completed the study. No significant differences in change from baseline in weekly average of the daily diary composite score occurred at week 12 between placebo (least-squares mean [standard error] -1.19 [0.12]) and trazpiroben (5, 25, and 50 mg: -1.11 [0.22], -1.17 [0.12], and -1.21 [0.12], respectively). Overall, 41.4% of participants receiving trazpiroben reported treatment-emergent adverse events (placebo, 39.7%). No serious events were considered trazpiroben-related; no life-threatening or fatal events were reported.
CONCLUSIONS & INFERENCES: There was no clinically meaningful difference in efficacy between trazpiroben and placebo in treating gastroparesis, based on the primary endpoint analysis. Trazpiroben was well tolerated with no new safety concerns identified, strengthening evidence supporting its favorable safety profile. NCT number: NCT03544229.
先前的曲匹派仑临床研究表明，曲匹派仑是一种多巴胺 D 2/ D 3 受体拮抗剂，可用于中重度特发性和糖尿病性胃轻瘫的长期治疗，能改善饱胀感等症状。本研究评估了曲匹派仑治疗特发性和糖尿病性胃轻瘫的疗效、安全性和耐受性，与安慰剂相比。
这是一项全球性、多中心、双盲、平行组、2b 期研究（NCT03544229），纳入了年龄在 18-85 岁之间、有症状的特发性或糖尿病性胃轻瘫的合格成年人。随机分组的参与者接受口服安慰剂或曲匹派仑 5、25 或 50mg，每日两次，持续 12 周，并完成美国神经胃肠病学和动力学会胃轻瘫主要症状指数-日常日记。从基线到 12 周的每周综合评分变化（主要终点）和治疗中出现的不良事件进行评估。数据以描述性方式进行总结。
共有 242 名参与者入组（平均[标准差]年龄 55.7[14.2]岁；75.6%为女性）；193 名参与者完成了研究。在 12 周时，与安慰剂相比（最小二乘均值[标准误差]-1.19[0.12]），曲匹派仑（5、25 和 50mg）在每周平均日常日记综合评分的变化方面没有统计学意义（-1.11[0.22]、-1.17[0.12]和-1.21[0.12]）。总体而言，41.4%接受曲匹派仑治疗的患者报告了治疗中出现的不良事件（安慰剂为 39.7%）。没有严重事件被认为与曲匹派仑有关；没有报告危及生命或致命的事件。
基于主要终点分析，曲匹派仑与安慰剂在治疗胃轻瘫方面没有明显的临床疗效差异。曲匹派仑具有良好的耐受性，未发现新的安全性问题，进一步证实了其安全性良好。NCT03544229。
