Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Clinical Drug Investigation
Published in: Clinical Drug Investigation 7/2006

01-07-2006 | Original Research Article

Efficacy and Safety of Helicobacter pylori Eradication Therapy with Omeprazole, Amoxicillin and High- and Low-Dose Clarithromycin in Japanese Patients

A Randomised, Double-Blind, Multicentre Study

Authors: Dr Kazuhide Higuchi, Takama Maekawa, Koichiro Nakagawa, Shinji Chouno, Takanobu Hayakumo, Naomi Tomono, Akio Orino, Hirohisa Tanimura, Kan Asahina, Naotaka Matsuura, Motohiko Endo, Masanori Hirano, Choitsu Sakamoto, Tsutomu Inomoto, Tetsuo Arakawa

Published in: Clinical Drug Investigation | Issue 7/2006

Login to get access

Abstract

Objective: Seven-day administration of omeprazole 40 mg/day + amoxicillin 1500 mg/day + clarithromycin 800 mg/day is currently approved in Japan for the eradication of Helicobacter pylori infection. We investigated the efficacy and safety of an omeprazole-based triple therapy regimen in combination with amoxicillin and low-dose clarithromycin in Japanese patients.
Methods: Patients were randomly assigned to either the low-dose group (omeprazole 40 mg/day + amoxicillin 1500 mg/day + clarithromycin 400 mg/day) or the high-dose group (omeprazole 40 mg/day + amoxicillin 1500 mg/day + clarithromycin 800 mg/day). A total of 288 patients were allocated to the low-dose (143) and high-dose (145) groups and were treated twice daily for 1 week.
Results: For the full-analysis set, H. pylori eradication rates were 81.1% (116/143 patients, 90% confidence interval [CI] 74.9, 86.3) in the low-dose group and 80.0% (116/145 patients, 90% CI 73.7, 85.3) in the high-dose group. Per-protocol eradication rates were 81.7% (103/126 patients, 90% CI 75.1, 87.2) and 84.1% (90/107 patients, 90% CI 77.1, 89.6), respectively. When patients with non-susceptibility to clarithromycin were excluded, eradication rates were ⋙80% for both gastric and duodenal ulcers in the two groups. The results suggested that eradication rates were affected more by susceptibility to clarithromycin than to amoxicillin. Both regimens were well tolerated.
Conclusion: This study demonstrated that an omeprazole-based triple-therapy regimen with clarithromycin 400 mg/day was as effective as that with clarithromycin 800 mg/day for H. pylori eradication.
Literature
1.
Warren JR, Marshall BJ. Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet 1983; I(8336): 1273–5
2.
Labenz J, Gyenes E, Rühl GH, et al. Helicobacter pylori reinfection and clinical course of peptic ulcer disease in the first year post-amoxicillin/omeprazole treatment. Eur J Gastroen-terol Hepatol 1992; 4: 893–6
3.
Bayerdörffer E, Mannes GA, Sommer A, et al. Long-term follow-up after eradication of Helicobacter pylori with a combination of omeprazole and amoxicillin. Scand J Gastroenterol Suppl 1993; 196: 19–25PubMedCrossRef
4.
NIH Consensus Development Panel on Helicobacter pylori in Peptic Ulcer Disease. Helicobacter pylori in peptic ulcer disease. JAMA 1994; 272: 65–9CrossRef
5.
6.
European Helicobacter Pylori Study Group. Current European concepts in the management of Helicobacter pylori infection. The Maastricht Consensus Report. Gut 1997; 41: 8–13
7.
Japanese Society for Helicobacter Research. The guideline for diagnosis and treatment of Helicobacter pylori infection [in Japanese]. Jpn J Helicobacter Res 2003; 4 Suppl.: 1–16
8.
Kuwayama H, Luk G, Yoshida S, et al. Efficacy of a low-dose omeprazole-based triple-therapy regimen for Helicobacterpylori eradication independent of cytochrome P450 genotype. The Japanese MACH study. Clin Drag Invest 2005; 25(5): 293–305CrossRef
9.
Asaka M, Sugiyama T, Kato M, et al. A multicenter, double-blind study on triple therapy with lansoprazole, amoxicillin and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients. Helicobacter 2001; 6(3): 254–61PubMedCrossRef
10.
Unge P, Kimura K, Sipponen P, et al. Do Japanese and Swedish peptic ulcer patients respond differently to Helicobacter pylori eradication therapies and what are their histological features? Scand J Gastroenterol 2003; 38(5): 482–90PubMedCrossRef
11.
Miwa H, Ohkura R, Murai T, et al. Impact of rabeprazole, a new proton pump inhibitor, in triple therapy for Helicobacter pylori infection: comparison with omeprazole and lansoprazole. Aliment Pharmacol Ther 1999; 13(6): 741–6PubMedCrossRef
12.
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): 8–14PubMedCrossRef
13.
Review Board of the Japanese Society of Gastroenterology. The guideline on the Helicobacter pylori eradication study (revised) [in Japanese]. J Jpn Soc Gastroenterol 1999; 96(2): 199–207
14.
Helicobacter pylori Panel of Antibiotic Susceptibility Assessment Committee in Japanese Society of Chemotherapy. Report on measurement of breakpoints for clarithromycin (CAM) and amoxicillin (AMPC) in Helicobacter pylori eradication therapy [in Japanese]. Jpn J Chemother 2002; 50: 54–8
15.
Lind T, Veldhuyzen van Zanten S, Unge P, et al. Eradication of Helicobacter pylori using one-week triple therapies combining omeprazole with two antimicrobials: the MACH I study. Helicobacter 1996; 1(3): 138–44PubMedCrossRef
16.
Lind T, Megraud F, Unge P, et al. The MACH 2 study: role of omeprazole in eradication of Helicobacter pylori with 1-week triple therapies. Gastroenterology 1999; 116: 248–53PubMedCrossRef
17.
Zanten SJ, Bradette M, Farley A, et al. The DU-MACH study: eradication of Helicobacter pylori and ulcer healing in patients with acute duodenal ulcer using omeprazole based triple therapy. Aliment Pharmacol Ther 1999; 13(3): 289–95PubMedCrossRef
18.
Malfertheiner P, Bayerdörffer E, Diete U, et al. The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer. Aliment Pharmacol Ther 1999; 13(6): 703–12PubMedCrossRef
19.
Gustavson LE, Kaiser JF, Edmonds AL, et al. Effect of omeprazole on concentrations of clarithromycin in plasma gastric tissue at steady state. Antimicrob Agents Chemother 1995; 39(9): 2078–83PubMedCrossRef
20.
Nakamura M, Spiller RC, Barrett DA. Gastric juice, gastric tissue and blood antibiotic concentrations following omeprazole, amoxicillin and clarithromycin triple therapy. Helicobacter 2003; 8(4): 294–9PubMedCrossRef
21.
Murakami K, Fujioka T. Helicobacter pylori eradication therapy and antibiotics [in Japanese]. In: Fujioka T, Sakaki N, editors. Helicobacter pylori forum: update of pathology and treatment. Tokyo: Igaku-Shoin, 2000: 118–25
22.
The Japanese Society for Helicobacter Research. Drag resistant Helicobacter pylori in Japan: results from resistant bacterial surveillance in 2002 [in Japanese]. Jpn J Helicobacter Res 2004; 6(1): 42–7
23.
Dojo M, Azuma T, Saito T, et al. Effects of CYP2C19 gene polymorphism on cure rates for Helicobacter pylori infection by triple therapy with proton pump inhibitor (omeprazole or rabeprazole), amoxycillin and clarithromycin in Japan. Dig Liver Dis 2001; 33(8): 671–5PubMedCrossRef
Metadata
Title
Efficacy and Safety of Helicobacter pylori Eradication Therapy with Omeprazole, Amoxicillin and High- and Low-Dose Clarithromycin in Japanese Patients
A Randomised, Double-Blind, Multicentre Study
Authors
Dr Kazuhide Higuchi
Takama Maekawa
Koichiro Nakagawa
Shinji Chouno
Takanobu Hayakumo
Naomi Tomono
Akio Orino
Hirohisa Tanimura
Kan Asahina
Naotaka Matsuura
Motohiko Endo
Masanori Hirano
Choitsu Sakamoto
Tsutomu Inomoto
Tetsuo Arakawa
Publication date
01-07-2006
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 7/2006
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.2165/00044011-200626070-00002