Randomized, parallel, double-blind comparison of the ulcer-healing effects of ilaprazole and omeprazole in the treatment of gastric and duodenal ulcers.
OBJECTIVE
Ilaprazole (IY-81149) is a new proton-pump inhibitor (PPI) not previously studied in human patients with ulcer disease. This study evaluated and compared it with a reference PPI, omeprazole, in the treatment of gastric and duodenal ulcers.


METHODS
This was a double-blind, parallel, randomized study. Patients aged 18 years and above with at least one endoscopically confirmed active non-malignant gastric/duodenal ulcer were treated with 20 mg/day omeprazole or 5 mg/day or 10 mg/day ilaprazole for four 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. Between-group differences were tested using ANOVA or ANCOVA, as appropriate. Statistical significance was assumed at a two-tailed p value of </=0.05.


RESULTS
Two hundred and twelve gastric ulcer patients (median age 53.3 years) and 306 duodenal ulcer patients (median age 49.7 years) were recruited; 71.8 and 85% of gastric and duodenal ulcer patients, respectively, completed the study. Ulcers were successfully healed in 64.29, 67.14, and 63.89% of gastric ulcer patients and 78.85, 83.65, and 78.57% of duodenal ulcer patients after treatment with 20 mg omeprazole, 5 mg ilaprazole, and 10 mg ilaprazole, respectively. Most patients (>90%) became asymptomatic after treatment. At the dosages administered, both drugs exhibited similar efficacy and a similar safety profile.


CONCLUSIONS
Ilaprazole is as tolerable, safe, and efficacious as omeprazole in the treatment of gastroduodenal ulcers, at a much lower dose (5 vs. 20 mg omeprazole).
Department of Medicine, Yong Loo Lin School of Medicine, National University Hospital, National University of Singapore, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore. mdchoky@nus.edu.sg
Khek Yu
KY
Ho
Arlene
A
Kuan
Felix
F
Zaño
Khean Lee
KL
Goh
Varocha
V
Mahachai
Dong Yeon
DY
Kim
Hwan Min
HM
Yoon
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004381:Duodenal Ulcer / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D013276:Stomach Ulcer / Q000188:drug therapy; D013454:Sulfoxides / Q000008:administration & dosage* / Q000009:adverse effects
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; C119615:ilaprazole; D009853:Omeprazole