Clinical Drug Investigation

, Volume 25, Issue 5, pp 293–305 | Cite as

Efficacy of a Low-Dose Omeprazole-Based Triple-Therapy Regimen for Helicobacter pylori Eradication Independent of Cytochrome P450 Genotype

The Japanese MACH Study
  • Hajime Kuwayama
  • Gordon Luk
  • Shunichi Yoshida
  • Takefumi Nakamura
  • Mitsuhiko Kubo
  • Naomi Uemura
  • Shigeru Harasawa
  • Mitsuru Kaise
  • Eiko Sanuki
  • Ken Haruma
  • Masaki Inoue
  • Tomohiko Shimatani
  • Hiroshi Mieno
  • Masahiro Kawanishi
  • Hidenobu Watanabe
  • Mituyoshi Nakashima
  • Saburo Nakazawa
Original Research Article

Abstract

Objectives: To investigate the efficacies of two different triple-therapy regimens (standard versus low doses), and the influence of cytochrome P450 enzyme (CYP) genetic polymorphism on these efficacies, in Japanese patients undergoing Helicobacter pylori eradication treatment.

Methods: All patients received 1 week of triple therapy. Patients in group A (low-dose regimen) received omeprazole 40 mg/day + amoxicillin 1500 mg/day + clarithromycin 800 mg/day; patients in group B (standard-dose regimen) received omeprazole 40 mg/day + amoxicillin 2000 mg/day + clarithromycin 1000 mg/day.

Results: A total of 225 patients (113 in group A and 112 in group B) were randomised to one of the two triple-therapy regimens. The eradication rates were 78.8% (89/113 patients; 95% CI 70.1, 85.9) in group A and 83.0% (93/112 patients; 95% CI 74.8, 89.5) in group B. Genetic polymorphism of CYP2C19, a major metabolic enzyme of omeprazole, did not affect eradication rates, while susceptibility to clarithromycin greatly affected the success of eradication. The cumulative ulcer relapse rate at 24 weeks after endoscopically documented ulcer healing (30 weeks after completion of the drug regimen) was 8.3% for group A and 12.5% for group B (log rank test: p = 0.6248). However, comparison of the cumulative relapse rate of 6.7% in patients after successful H. pylori eradication with the relapse rate of 27.3% in those who failed H. pylori eradication revealed a significant difference in the remission-time curve (log rank test: p = 0.0047). This finding suggested the existence of a relationship between H. pylori eradication failure and ulcer relapse. Both drug regimens were well tolerated. Endoscopically proven reflux esophagitis developed in about 10% of patients after eradication, but was not clinically significant.

Conclusions: One week of triple therapy with a low-dose regimen provides adequate H. pylori eradication in Japanese patients. CYP genetic polymorphism is of minimal clinical significance with both triple-therapy regimens.

Keywords

Omeprazole Duodenal Ulcer Clarithromycin Pylorus Eradication Eradication Rate 

Notes

Acknowledgements

This study was supported by a research grant from AstraZeneca. The authors have no conflicts of interest directly relevant to the content of this study.

The physicians andmedical institutions involved in this clinical study were: Shunichi Yoshida, Kazuhiko Nishimura, Ikushi Sekimoto, Tadashi Soga and Seiichi Hirano, Department of Gastroenterology, Akashi Municipal Hospital, Akashi; Takeshi Nakamura, Iichiro Tomoda, Kiyotaka Kawaguchi, Takayuki Nada and Keiichi Kiritani, Department of Internal Medicine, Kitano Hospital, Osaka; Mitsuuroko Kubo, Hirohisa Tanimura, Masahide Onoshita and Norihiro Enomoto, Department of Internal Medicine, Osaka Police Hospital, Osaka; Naomi Uemura, Shiro Okamoto and Soichiro Yamamoto, Department of Gastroenterology, Kure Kyousai Hospital, Kure; Tadakazu Sekine, Yoshinari Koyanagi, Hikaru Takahashi and Shigeru Matsui, Department of Gastroenterology, Kawaguchi General Hospital, Kawaguchi; Mitsuru Kaise, Nobuaki Suzuki, Jun Miwa, Department of Gastroenterology, Toshiba Hospital, Tokyo; Hajime Kuwayama, Morio Takahashi, Hiroshi Takada, Yoshiya Matsukawa, Hironobu Takada, Shigeki Oka, Department of Gastroenterology, Koshigaya Hospital of Dokkyo University School of Medicine, Koshigaya; Eiko Sanuki, Hirofumi Kobayashi, Tatsuro Tanimoto, Department of Internal Medicine, Saiseikai Hiroshima Hospital, Hiroshima; Ken Haruma, Koji Sumii, Nobuhiro Tanaka, Yasuhiko Kitadai, Masami Kunihiro, First Department of Internal Medicine, Hiroshima University Medical Hospital, Hiroshima; Tomohiko Shimatani, Masaki Inoue, Yoko Horikawa, General Medicine, Hiroshima University Medical Hospital, Hiroshima; Hiroshi Mieno, Kiminori Ito, Mitsuhiro Mihara, First Department of Internal Medicine, Hiroshima Railway Hospital, Hiroshima; Masahiro Kawanishi, Atsunori Kodoi, Shintaro Takagi, Department of Internal Medicine, Hiroshima Mitsubishi Hospital, Hiroshima.

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Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  • Hajime Kuwayama
    • 1
  • Gordon Luk
    • 1
  • Shunichi Yoshida
    • 2
  • Takefumi Nakamura
    • 3
  • Mitsuhiko Kubo
    • 4
  • Naomi Uemura
    • 5
  • Shigeru Harasawa
    • 6
  • Mitsuru Kaise
    • 7
  • Eiko Sanuki
    • 8
  • Ken Haruma
    • 9
  • Masaki Inoue
    • 10
  • Tomohiko Shimatani
    • 11
  • Hiroshi Mieno
    • 12
  • Masahiro Kawanishi
    • 13
  • Hidenobu Watanabe
    • 14
  • Mituyoshi Nakashima
    • 15
  • Saburo Nakazawa
    • 16
  1. 1.Department of Gastroenterology and HepatologyUniversity Hospital of Koshigaya, Dokkyo University School of MedicineCity of Koshigaya, SaitamaJapan
  2. 2.Department of GastroenterologyAkashi Municipal HospitalAkashiJapan
  3. 3.Department of Internal MedicineKitano Hospital of the Tafu Koufuukai Nonprofit CorporationOsakaJapan
  4. 4.Department of Internal MedicineOsaka Police HospitalOsakaJapan
  5. 5.Department of GastroenterologyKure Kyousai Hospital of KKRKureJapan
  6. 6.Kawaguchi General Hospital of Saitama Prefecture SaiseikaiKawaguchiJapan
  7. 7.Department of GastroenterologyToshiba HospitalTokyoJapan
  8. 8.Department of Internal MedicineSaiseikai Hiroshima Hospital of the Imperial Foundation of Social Welfare CorporationHiroshimaJapan
  9. 9.Department of 1st Internal MedicineHiroshima University School of MedicineHiroshimaJapan
  10. 10.Department of Geriatric Medicine, School of MedicineInstitute of Health Sciences, Hiroshima UniversityHiroshimaJapan
  11. 11.Department of General MedicineHiroshima University School of MedicineHiroshima, HiroshimaJapan
  12. 12.Department of 1st Internal MedicineHiroshima Railway Hospital of West Japan RailwayHiroshimaJapan
  13. 13.Department of Internal MedicineHiroshima Mitsubishi HospitalHiroshimaJapan
  14. 14.Department of 1st PathologyNiigata University School of MedicineNigataJapan
  15. 15.Hamamatsu University School of MedicineHamamatsuJapan
  16. 16.Yamashita HospitalIchinomiyaJapan

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