Efficacy and safety of cinitapride in the treatment of mild to moderate postprandial distress syndrome-predominant functional dyspepsia.
OBJECTIVE
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.


METHODS
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.
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.
Yiqi
Y
Du
Tun
T
Su
Xinmiao
X
Song
Jun
J
Gao
Duowu
D
Zou
Changjing
C
Zuo
Weifen
W
Xie
Bangmao
B
Wang
Zhiguang
Z
Zhang
Jianming
J
Xu
Dean
D
Tian
Hesheng
H
Luo
Zhenyu
Z
Zhang
Shaofeng
S
Wang
Jianping
J
Chen
Jizhong
J
Guo
Lei
L
Gong
Yanbing
Y
Ding
Zhaoshen
Z
Li
D000293:Adolescent; D000328:Adult; D000368:Aged; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D004294:Domperidone / Q000009:adverse effects / Q000627:therapeutic use*; D018492:Dopamine Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D065127:Dopamine D2 Receptor Antagonists; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period; D012720:Severity of Illness Index; D013577:Syndrome; D055815:Young Adult
D001549:Benzamides; D018492:Dopamine Antagonists; D065127:Dopamine D2 Receptor Antagonists; D004294:Domperidone; C045316:cinitapride