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Randomized, parallel, double-blind comparison of the ulcer-healing effects of ilaprazole and omeprazole in the treatment of gastric and duodenal ulcers

  • Original Article—Alimentary Tract
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Abstract

Purpose

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).

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References

  1. Periclou AP, Goldwater R, Lee SM, Park DW, Kim DY, Cho KD, et al. A comparative pharmacodynamic study of ILAPRAZOLE versus omeprazole in patients with gastroesophageal reflux disease. Clin Pharmacol Ther. 2000;68(3):304–11.

    Article  PubMed  CAS  Google Scholar 

  2. Kil BJ, Kim IW, Shin CY, Jeong JH, Jun CH, Lee SM, et al. Comparison of IY81149 with omeprazole in rat reflux oesophagitis. J Auton Pharmacol. 2000;20(5–6):291–6.

    Article  PubMed  CAS  Google Scholar 

  3. Goldwater R, Lee SM, Chung GJ, Kim DY, Cho KD, Boileau F. A phase I, randomized, parallel placebo-controlled safety, tolerance and pharmacokinetic study of multiple doses of IY-8119 in fasting male volunteers. ASCPT; 1999 March 18–20; San Antonio, Texas.

  4. World Medical Association. Declaration of Helsinki. Ferney-Voltaire: WMA, 2002. http://www.wma.net/e/policy/b3.htm (accessed 17 April 2006).

  5. Miyake T, Suzaki T, Oishi M. Correlation of gastric ulcer healing features by endoscopy, stereoscopic microscopy, and histology, and a reclassification of the epithelial regenerative process. Dig Dis Sci. 1980;25(1):8–14.

    Article  PubMed  CAS  Google Scholar 

  6. Gillen D, Wirz AA, Neithercut WD, Ardill JES, McColl KEL. Helicobacter pylori infection potentiates the inhibition of gastric acid secretion by omeprazole. Gut. 1999;44:468–75.

    Article  PubMed  CAS  Google Scholar 

  7. Holtmann G, Cain C, Malfertheiner P. Helicobacter pylori infection accelerates healing of reflux esophagitis during treatment with the proton pump inhibitor pantoprazole. Gastroenterology. 1999;117:11–6.

    Article  PubMed  CAS  Google Scholar 

  8. Labenz J, Tillenburg B, Peitz U, Idstrom JP, Verdu EF, Stolte M, et al. Helicobacter pylori augments the pH increasing effect of omeprazole in patients with duodenal ulcer. Gastroenterology. 1996;110:725–32.

    Article  PubMed  CAS  Google Scholar 

  9. Suzuki J, Mine T, Kobayasi I, Fujita T. Relationship between the eradication of Helicobacter pylori and the healing pattern of peptic ulcer. J Clin Gastroenterol. 1998;27(Suppl 1):S159–62.

    Article  PubMed  Google Scholar 

  10. Vakil N, Hahn B, McSorley D. Recurrent symptoms and gastro-oesophageal reflux disease in patients with duodenal ulcer treated for Helicobacter pylori infection. Aliment Pharmacol Ther. 2000;14(1):45–51.

    Article  PubMed  CAS  Google Scholar 

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Acknowledgments

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.

Author information

Authors and Affiliations

  1. Department of Medicine, Yong Loo Lin School of Medicine, National University Hospital, National University of Singapore, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore

    Khek Yu Ho

  2. Department of Gastroenterology and Hepatology, National University Hospital, Singapore, Singapore

    Khek Yu Ho

  3. Vicente Sotto Medical Center, Cebu, Philippines

    Arlene Kuan

  4. Philippine General Hospital, Manila, Philippines

    Felix Zaño

  5. University Malaya Medical Centre, Kuala Lumpur, Malaysia

    Khean Lee Goh

  6. Chulalonkorn Hospital, Bangkok, Thailand

    Varocha Mahachai

  7. Ilyang Central Research Institute, Yongin, South Korea

    Dong Yeon Kim & Hwan Min Yoon

Authors
  1. Khek Yu Ho
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  2. Arlene Kuan
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  3. Felix Zaño
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  4. Khean Lee Goh
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  5. Varocha Mahachai
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  6. Dong Yeon Kim
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  7. Hwan Min Yoon
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Corresponding author

Correspondence to Khek Yu Ho.

Appendix

Appendix

In addition to the authors, the IY-81149 Study Group includes the following persons: Judy Lao Tan, Cebu Doctors Hospital, Philippines; Muhammad Radzi Abu Hassan, Hospital Alor Setar, Malaysia; Jayaram Menon, Queen Elizabeth Hospital, Malaysia; Jane Ricaforte—Campos, Medical Centre Manila, Philippines; late Panir Chelvam, The Gastroenterology Centre, Malaysia; Jose Sollano Jr, University of Santo Tomas Hospital, Philippines; Ernesto Que, East Avenue Medical Centre, Philippines; Siriwat Anantapunpong, Rajavithi Hospital, Thailand; Roland Chong Siong Eng, Gleneagles Hospital, Singapore; Sompote Lee, Chiang Mai Ram Hospital, Thailand; Thanakorn Harnsomburana, Lerdsin General Hospital, Thailand; Suraphol Churnratanakul, Premongkutklao Hospital, Thailand; Chutima Pramoolsinsap, Ramathibodi Hospital, Thailand; Udom Kachintorn, Siriraj Hospital, Thailand; Voraphan Saowaros, Police General Hospital, Thailand; Ian Roberts-Thomson, Queen Elizabeth Hospital, Australia; Marilyn Arguillas, Davao Doctors Hospital, Philippines; S Ganesananthan, Kuala Lumpur Hospital, Malaysia; Williams David, St. Vincent Hospital (Melb), Australia; Satawat Thongsawat, Chiang Mai University Hospital, Thailand; Daniel Parungao, University o the East. Ramon Magsaysay Medical Centre, Philippines; Mark Appleyard, Royal Brisbane Hospital, Australia; Timothy Florin, Mater Adult Misericodiae Hospital, Australia; and Sanjay Nandurkar, Box Hill Hospital, Australia.

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Ho, K.Y., Kuan, A., Zaño, F. et al. Randomized, parallel, double-blind comparison of the ulcer-healing effects of ilaprazole and omeprazole in the treatment of gastric and duodenal ulcers. J Gastroenterol 44, 697–707 (2009). https://doi.org/10.1007/s00535-009-0072-4

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  • DOI: https://doi.org/10.1007/s00535-009-0072-4

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