title: A large-scale nationwide multicenter prospective observational study of triple therapy using rabeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in Japan.
abstract: BACKGROUND
  In recent years in Japan, the rate of clarithromycin (CAM) resistance in Helicobacter pylori has risen to around 30%, and the eradication rate with triple therapy [proton pump inhibitor + amoxicillin (AMPC) + CAM] has been trending downward to around 70%. In 2007, rabeprazole (RPZ)-based triple therapy (RPZ + AMPC + CAM: RAC therapy) was approved in Japan, and a large-scale nationwide study was therefore initiated to evaluate the efficacy and safety of RAC therapy in clinical practice.
  
  
  METHODS
  Patients with H. pylori-positive gastric/duodenal ulcer (including ulcer scars) were administered triple therapy comprising RPZ 10 mg, AMPC 750 mg, and CAM 200 mg (or 400 mg), twice daily for 7 days.
  
  
  RESULTS
  The eradication rate was 80.7% (2,551/3,162). The results of multivariate analysis indicated the following as factors affecting the eradication rate: sex, treatment compliance, history of H. pylori treatment, presence of urologic disease, presence of respiratory disease, and year of starting treatment. The incidence of adverse drug reactions (such as diarrhea and dysgeusia) was 4.4% (166/3,789). The results of multivariate analysis indicated the following as factors affecting the incidence of adverse drug reactions: sex, daily CAM dose, and history of allergies.
  
  
  CONCLUSIONS
  In a large-scale nationwide study of use in clinical practice, RAC therapy was confirmed to be effective and safe.
authors: Department of Gastroenterology, Oita University, 1-1 Idaigaoka, Hasama-machi, Yufu, Oita 879-5593, Japan. fujioka@oita-u.ac.jp
authors: Toshio
authors: T
authors: Fujioka
authors: Nobuo
authors: N
authors: Aoyama
authors: Kyoko
authors: K
authors: Sakai
authors: Yoshiyuki
authors: Y
authors: Miwa
authors: Mineo
authors: M
authors: Kudo
authors: Junichi
authors: J
authors: Kawashima
authors: Yasuo
authors: Y
authors: Matsubara
authors: Jun
authors: J
authors: Miwa
authors: Koji
authors: K
authors: Yakabi
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D064750:Rabeprazole; D012737:Sex Factors; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D064750:Rabeprazole; D000658:Amoxicillin; D017291:Clarithromycin