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.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, Osaka City University, Osaka, Japan. khiguchi@med.osaka-cu.ac.jp
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
authors.forename: Takama
authors.initials: T
authors.lastname: Maekawa
authors.forename: Koichiro
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Shinji
authors.initials: S
authors.lastname: Chouno
authors.forename: Takanobu
authors.initials: T
authors.lastname: Hayakumo
authors.forename: Naomi
authors.initials: N
authors.lastname: Tomono
authors.forename: Akio
authors.initials: A
authors.lastname: Orino
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Tanimura
authors.forename: Kan
authors.initials: K
authors.lastname: Asahina
authors.forename: Naotaka
authors.initials: N
authors.lastname: Matsuura
authors.forename: Motohiko
authors.initials: M
authors.lastname: Endo
authors.forename: Masanori
authors.initials: M
authors.lastname: Hirano
authors.forename: Choitsu
authors.initials: C
authors.lastname: Sakamoto
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Inomoto
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Arakawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D065731:Cytochrome P-450 CYP2C19; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D006899:Mixed Function Oxygenases / Q000235:genetics; D009853:Omeprazole / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000658:Amoxicillin; D006899:Mixed Function Oxygenases; D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D017291:Clarithromycin; D009853:Omeprazole