title: A multicenter prospective observational study of triple therapy with rabeprazole, amoxicillin and metronidazole for Helicobacter pylori in Japan.
abstract: OBJECTIVE
  Triple therapy with rabeprazole (RPZ), amoxicillin (AMPC) and metronidazole (MNZ) (RPZ+AMPC+MNZ therapy: RAM therapy) has been approved by the Japanese Ministry of Health, Labour and Welfare as a second-line therapy for Helicobacter pylori-positive gastric and duodenal ulcers in Japan. The present multicenter prospective observational study aimed to investigate the safety and efficacy of RAM therapy in clinical practice.
  
  
  METHODS
  Patients with H. pylori-positive gastric or duodenal ulcers (including ulcer scars) in whom first-line therapy was unsuccessful were administered 10 mg of RPZ, 750 mg of AMPC and 250 mg of MNZ twice daily for seven days (total: 14 doses) based on an approved dose and regimen. Patient background factors, including complications, previous medical history, concomitant drugs, eradication results and adverse events were recorded by the investigator.
  
  
  RESULTS
  The incidence of adverse drug reactions was 2.21% and the H. pylori eradication rate was 92.8%. Subgroup analyses performed to investigate the patient background factors affecting safety and efficacy revealed no factors that significantly affected the incidence of adverse drug reactions or the H. pylori eradication rate.
  
  
  CONCLUSIONS
  Amid reports of decreased eradication rates with clarithromycin-based first-line therapy, the >90%H. pylori eradication rate achieved in the present study demonstrates the clinical efficacy of RAM therapy in subjects in whom first-line therapy is unsuccessful.
authors.affiliation: Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd., Japan. k-sugizaki@hhc.eisai.co.jp
authors.forename: Katsuya
authors.initials: K
authors.lastname: Sugizaki
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Sakata
authors.forename: Toshihisa
authors.initials: T
authors.lastname: Arai
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Furuhata
authors.forename: Norio
authors.initials: N
authors.lastname: Iinuma
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Suzuki
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D007564:Japan; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D064750:Rabeprazole; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D064750:Rabeprazole; D000658:Amoxicillin