A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis.
OBJECTIVE
Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Previous studies have indicated ilaprazole to be safer and more effective in treating duodenal ulcers as compared with omeprazole. Being a novel PPI, ilaprazole may be used in the treatment of reflux esophagitis. The purpose of this study was to evaluate the safety and efficacy of ilaprazole tablets in the treatment of reflux esophagitis.


METHODS
This study used a randomized, double-blind, multi-center, active-comparison design. The patients were randomly divided into an ilaprazole group (10 mg once daily and 15 mg once daily) and an esomeprazole group (40 mg once daily). Both the groups were treated for 8 weeks. Heartburn and reflux symptoms prior to treatment, and 4 and 8 weeks after the treatment were assessed. Gastroscopy was performed after 4 and 8 weeks. The healing rate after 4 weeks treatment was compared. If esophagitis was healed at the end of 4 weeks, patients did not undergo gastroscopy at the end of 8 weeks.


RESULTS
Three hundred and twenty-five patients were enrolled in this study. The 4-week full analysis set (per-protocol set) healing rates in the esomeprazole 40-mg group, the ilaprazole 10-mg group, and the ilaprazole 15-mg group were: 71.43 % (78.89 %), 81.31 % (86.73 %), and 71.70 % (81.40 %), respectively, p = 0.1595 (0.4122); the 8-week healing rates were 84.76 % (93.33 %), 88.79 % (94.90 %), and 85.85 % (97.67 %), respectively, p = 0.6689 (0.4049). Drug-related adverse events rate were 10.48 %, 14.02 %, and 15.09 %, respectively, in the three groups (p = 0.6114).


CONCLUSIONS
The efficacy and safety of ilaprazole (10 mg/day, 15 mg/day) in treating reflux esophagitis was similar to esomeprazole (40 mg/day). Ilaprazole (10 mg/day) has a smaller dosage, hence it should be considered more in clinical uses.


BACKGROUND
ClinicalTrials.gov NCT01107938.
Department of Gastroenterology, Peking University Third Hospital Beijing, 49, Huayuan North Road, Haidian District, Beijing, 100191, China.
Yan
Y
Xue
Livzon Pharmacertical Group Inc., Zhuhai, Guangdong, China.
Xianghong
X
Qin
Department of Gastroenterology, Peking University Third Hospital Beijing, 49, Huayuan North Road, Haidian District, Beijing, 100191, China. zhoumed@126.com.
Liya
L
Zhou
Department of Gastroenterology, Peking University Third Hospital Beijing, 49, Huayuan North Road, Haidian District, Beijing, 100191, China.
Sanren
S
Lin
The Fourth Military Medical University, Xi'an, Shanxi, China.
Ling
L
Wang
Livzon Pharmacertical Group Inc., Zhuhai, Guangdong, China.
Haitang
H
Hu
The Fourth Military Medical University, Xi'an, Shanxi, China.
Jielai
J
Xia
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000328:Adult; D004311:Double-Blind Method; D064098:Esomeprazole / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005260:Female; D006356:Heartburn / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; C119615:ilaprazole; D064098:Esomeprazole