A new PPI, ilaprazole compared with omeprazole in the treatment of duodenal ulcer: a randomized double-blind multicenter trial.

Abstract

GOALS:

To investigate the efficacy and safety of a new proton pump inhibitor (PPI), ilaprazole (IY-81149) in the treatment of duodenal ulcers and provide some characteristics of the dose-response relationship for later studies.

BACKGROUND:

PPIs have been used therapeutically for many years, and shown great efficacy in accelerating ulcer healing. Currently researches are focused on more potent PPIs. Some preclinical studies have shown that ilaprazole might be such a new substitute.

STUDY:

235 patients with at least 1 endoscopically diagnosed active duodenal ulcer were enrolled in a randomized trial. Patients were randomized into 4 groups (5, 10, and 20 mg/d ilaprazole, with 20 mg/d omeprazole as positive control) and treated for up to 4 weeks. Forty patients accepted continuous 24-hour pH measurements after the fifth dose. The primary endpoint was ulcer healing rate at week 4.

RESULTS:

The efficacy analyses were based on 235 patients. At week 4, 86.4%, 93.1%, 86.4%, and 89.8% patients treated with 5 mg ilaprazole, 10 mg ilaprazole, 20 mg ilaprazole, and 20 mg omeprazole once daily, respectively had ulcers healed (P=0.59). The majority of patients (>70%) became asymptomatic after 4 weeks treatment. Both drugs with stipulated dosages exhibited similar efficacy and safety profiles. Gastric acid suppression increased with increasing dose of ilaprazole in pH study.

CONCLUSIONS:

Ilaprazole is as tolerable, safe, and efficacious as omeprazole in the treatment of duodenal ulcers, especially at a lower dose (10 mg/d ilaprazole vs. 20 mg/d omeprazole). (ClinicalTrials.gov ID: NCT00953381).

• Authors: Ling Wang, Liya Zhou, Sanren Lin, Haitang Hu, Jielai Xia
• Journal: Journal of clinical gastroenterology (J Clin Gastroenterol) Vol. 45 Issue 4 Pg. 322-9 (Apr 2011) ISSN: 1539-2031 [Electronic] United States
• PMID: 20679904 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Anti-Ulcer Agents
• Benzimidazoles
• Proton Pump Inhibitors
• Sulfoxides
• ilaprazole
• Omeprazole

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Adult
• Anti-Ulcer Agents (administration & dosage, adverse effects, therapeutic use)
• Benzimidazoles (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Duodenal Ulcer (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Omeprazole (administration & dosage, adverse effects, therapeutic use)
• Proton Pump Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Sulfoxides (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome