The main goal of this study was to explore the dose-effect relationship of ilaprazole.
Ilaprazole is a kind of benzimidazole proton-pump inhibitor, which was confirmed efficacious and safe in treatment of duodenal ulcer (DU). However, the dose-effect relationship of ilaprazole was not clear.
This was a double-blind, parallel, randomized study. Patients aged above 18 years with at least one endoscopically confirmed active nonmalignant DU were treated with rabeprazole 10 mg or ilaprazole 10 mg/5 mg for 4 weeks. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.
A total of 390 patients completed the study finally. Ulcers were successfully healed in 75.38%, 77.86%, and 83.72% of patients after 4-week treatment with rabeprazole 10 mg, ilaprazole 5 mg, and ilaprazole 10 mg, respectively. The 4-week healing rate difference between rabeprazole 10 mg and ilaprazole 5 mg was 2.48% (95% confidence interval: −7.79% to 12.74%) leading to accept the noninferiority hypothesis. Logistic regression model suggested that ilaprazole 10 mg was superior to ilaprazole 5 mg at week 2 (odds ratio, 1.92; 95% confidence interval: 1.02, 3.59; P=0.04). Most patients (80%) became asymptomatic after treatment. At the dosages administered, the 3 drug groups exhibited similar efficacy and a similar safety profile.
Ilaprazole 5 mg is not inferior to rabeprazole 10 mg in treating DU, and a dose-effect relationship have been revealed between 5 mg and 10 mg of ilaprazole.
*Department of Health Statistics, Fourth Military Medical University
‡Department of Gastroenterology, Fourth Military Medical University Xijing Hospital, Xi’an, Shaanxi
†Livzon Pharmaceutical Group Inc., Zhuhai, Guangdong, China
The study was supported by the National Natural Science Foundation of China (grant number: 81773553) and Livzon Pharmaceutical Group Inc. (China). This multicenter clinical trial was conducted with the assistance of the following 5 centers: Xijing Hospital, The Fourth Military Medical University, Shaanxi Province; General Hospital of Guangzhou Military Command of PLA, Guangdong Province; The Second Affiliated Hospital of Sun Yat-sen University, Guangdong Province; The Fifth Affiliated Hospital of Sun Yat-sen University, Guangdong Province; Xinqiao Hospital, The Third Military Medical University, Chongqing.
L.F. and Q.X. contributed equally.
The clinical trial registration number of the study is NCT 02847455.
The authors declare that they have nothing to disclose.
Address correspondence to: Wang Ling, MD, Department of Health Statistics, Fourth Military Medical University, Xi’an 710032, Shaanxi, China (e-mail: firstname.lastname@example.org).
Address correspondence to: Han Ying, MD, Department of Gastroenterology, Fourth Military Medical University Xijing Hospital, Xi’an 710032, Shaanxi, China (e-mail: email@example.com).
Received June 21, 2018
Accepted September 22, 2018