Abstract
Background and 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).
Conclusion
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.
Trial registration: ClinicalTrials.gov NCT01107938.
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Acknowledgments
The authors wish to acknowledge the Department of Gastroenterology, Peking Union Medical College Hospital; Department of Gastroenterology, The General Hospital of the People’s Liberation Army; Department of Gastroenterology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Department of Gastroenterology, Changhai Hospital, Shanghai; Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University; Department of Gastroenterology, Wuhan Union Hospital; Department of Gastroenterology, Renmin Hospital of Wuhan University; Department of Gastroenterology, Guangzhou First People’s Hospital.
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Funding
The study was sponsored by Livzon Pharmaceutical Group Inc., China.
Funding
The study was sponsored by Livzon Pharmaceutical Group Inc., China.
Conflict of interest
Xianghong Qin is an employee of Livzon Pharmaceutical Group Inc. Yan Xue, Liya Zhou, Sanren Lin, Ling Wang, Haitang Hu, and Jielai Xia declare no conflicts of interest that affect the results of the study.
Ethical approval
This study was approved by the Ethics Committee of the Health Center of Peking University.
Informed consent
All study participants provided written informed consent before being included in the study.
Additional information
Y. Xue and X. Qin contributed equally to this work.
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Xue, Y., Qin, X., Zhou, L. et al. A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis. Clin Drug Investig 36, 985–992 (2016). https://doi.org/10.1007/s40261-016-0446-3
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DOI: https://doi.org/10.1007/s40261-016-0446-3