Randomized, parallel, double-blind comparison of the ulcer-healing effects of ilaprazole and omeprazole in the treatment of gastric and duodenal ulcers
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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.
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.
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.
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).
KeywordsIlaprazole Proton-pump inhibitor Gastroduodenal ulcer Acid suppression
The authors wish to thank Dr Jennie Wong for her editorial assistance. These data were published in abstract form (Gut 2006; 55 (Suppl V): A79) and were presented orally at the 14th United European Gastroenterology Week, Berlin, 2006.
Conflict of interest statement
This study was sponsored by Ilyang Pharmaceutical Company, Limited, Seoul, South Korea. None of the authors has financial interest in the study.
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