Yiqi Du1, Tun Su, Xinmiao Song, Jun Gao, Duowu Zou, Changjing Zuo, Weifen Xie, Bangmao Wang, Zhiguang Zhang, Jianming Xu, Dean Tian, Hesheng Luo, Zhenyu Zhang, Shaofeng Wang, Jianping Chen, Jizhong Guo, Lei Gong, Yanbing Ding, Zhaoshen Li. 1. Departments of *Gastroenterology †Nuclear Medicine, Shanghai Changhai Hospital, Second Military Medical University ‡Department of Gastroenterology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai §Department of Gastroenterology, Tianjin Medical University General Hospital ∥Department of Gastroenterology, The 2nd Hospital of Tianjin Medical University, Tianjin ¶Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University, Hefei #Department of Gastroenterology, Tongji Hospital, Huazhong University of Science & Technology **Department of Gastroenterology, People's Hospital of Wuhan University, Wuhan ††Department of Gastroenterology, Nanjing First Hospital, Nanjing ‡‡Department of Gastroenterology, The 2nd Affiliated Hospital of Soochow University, Suzhou §§Department of Gastroenterology, The 3rd Affiliated Hospital of Soochow University, Changzhou ∥∥Department of Gastroenterology, Wuxi People's Hospital ¶¶Department of Gastroenterology, Wuxi 2nd People's Hospital, Wuxi ##Department of Gastroenterology, Yangzhou 1st People's Hospital, Yangzhou, China.
Abstract
GOALS AND BACKGROUND:Functional dyspepsia (FD) is a complex disease with a variety of dyspeptic symptoms. Little is known about the clinical efficacy of cinitapride, a 5-HT₄ agonist and D₂ antagonist, in treating FD. STUDY: This randomized, double-blind, double-dummy, positive-controlled study compared the efficacy and safety of cinitapride (1 mg) and domperidone (10 mg) tid for 4 weeks in 383 consecutive patients with mild to moderate, postprandial distress syndrome-predominant dyspeptic symptoms according to Rome III criteria. The primary endpoint was the noninferiority of cinitapride compared with domperidone in relief of symptoms. The overall patient evaluation of treatment and open gastric emptying effects of both drugs were treated as the secondary endpoints. RESULTS: The rates of symptom relief by cinitapride and domperidone after 4 weeks did not differ significantly on intension-to-treat analysis (85.8% vs. 81.8%, P=0.332). Cinitapride significantly reduced the overall severity of postprandial fullness, early satiation, and bloating (4.3±3.9 vs. 17.8±6.6, P<0.001); and it was superior to the effects of domperidone (5.4±4.9 vs. 18.4±6.9, P<0.001; P=0.021 between groups). Cinitapride also decreased the mean half-gastric emptying time from 131.1±119.4 to 86.5±18.7 minutes (P=0.0002). There was a positive relationship between symptoms and gastric emptying time (r=0.332, P=0.041). Cinitapride-related adverse events were observed in 9.1% of patients, including 1 patient with extrapyramidal symptoms. No patient experienced QT interval prolongation. CONCLUSIONS: This phase III trial has confirmed a noninferior efficacy of cinitapride over domperidone for patients with mild to moderate, postprandial distress syndrome-predominant FD. Cinitapride usage is well tolerated, but its cardiovascular events need further evaluation.
RCT Entities:
GOALS AND BACKGROUND:Functional dyspepsia (FD) is a complex disease with a variety of dyspeptic symptoms. Little is known about the clinical efficacy of cinitapride, a 5-HT₄ agonist and D₂ antagonist, in treating FD. STUDY: This randomized, double-blind, double-dummy, positive-controlled study compared the efficacy and safety of cinitapride (1 mg) and domperidone (10 mg) tid for 4 weeks in 383 consecutive patients with mild to moderate, postprandial distress syndrome-predominant dyspeptic symptoms according to Rome III criteria. The primary endpoint was the noninferiority of cinitapride compared with domperidone in relief of symptoms. The overall patient evaluation of treatment and open gastric emptying effects of both drugs were treated as the secondary endpoints. RESULTS: The rates of symptom relief by cinitapride and domperidone after 4 weeks did not differ significantly on intension-to-treat analysis (85.8% vs. 81.8%, P=0.332). Cinitapride significantly reduced the overall severity of postprandial fullness, early satiation, and bloating (4.3±3.9 vs. 17.8±6.6, P<0.001); and it was superior to the effects of domperidone (5.4±4.9 vs. 18.4±6.9, P<0.001; P=0.021 between groups). Cinitapride also decreased the mean half-gastric emptying time from 131.1±119.4 to 86.5±18.7 minutes (P=0.0002). There was a positive relationship between symptoms and gastric emptying time (r=0.332, P=0.041). Cinitapride-related adverse events were observed in 9.1% of patients, including 1 patient with extrapyramidal symptoms. No patient experienced QT interval prolongation. CONCLUSIONS: This phase III trial has confirmed a noninferior efficacy of cinitapride over domperidone for patients with mild to moderate, postprandial distress syndrome-predominant FD. Cinitapride usage is well tolerated, but its cardiovascular events need further evaluation.
Authors: John M Rosen; Jose T Cocjin; Jennifer V Schurman; Jennifer M Colombo; Craig A Friesen Journal: World J Gastrointest Pharmacol Ther Date: 2014-08-06