title: Proton pump inhibitor step-down therapy for GERD: a multi-center study in Japan.
abstract: OBJECTIVE
  To investigate the predictors of success in step-down of proton pump inhibitor and to assess the quality of life (QOL).
  
  
  METHODS
  Patients who had heartburn twice a week or more were treated with 20 mg omeprazole (OPZ) once daily for 8 wk as an initial therapy (study 1). Patients whose heartburn decreased to once a week or less at the end of the initial therapy were enrolled in study 2 and treated with 10 mg OPZ as maintenance therapy for an additional 6 mo (study 2). QOL was investigated using the gastrointestinal symptom rating scale (GSRS) before initial therapy, after both 4 and 8 wk of initial therapy, and at 1, 2, 3, and 6 mo after starting maintenance therapy.
  
  
  RESULTS
  In study 1, 108 patients were analyzed. Their characteristics were as follows; median age: 63 (range: 20-88) years, sex: 46 women and 62 men. The success rate of the initial therapy was 76%. In the patients with successful initial therapy, abdominal pain, indigestion and reflux GSRS scores were improved. In study 2, 83 patients were analyzed. Seventy of 83 patients completed the study 2 protocol. In the per-protocol analysis, 80% of 70 patients were successful for step-down. On multivariate analysis of baseline demographic data and clinical information, no previous treatment for gastroesophageal reflux disease (GERD) [odds ratio (OR) 0.255, 95% CI: 0.06-0.98] and a lower indigestion score in GSRS at the beginning of step-down therapy (OR 0.214, 95% CI: 0.06-0.73) were found to be the predictors of successful step-down therapy. The improved GSRS scores by initial therapy were maintained through the step-down therapy.
  
  
  CONCLUSIONS
  OPZ was effective for most GERD patients. However, those who have had previous treatment for GERD and experience dyspepsia before step-down require particular monitoring for relapse.
authors.affiliation: Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama 700-8558, Japan. takaotsuzuki@yahoo.co.jp
authors.forename: Takao
authors.initials: T
authors.lastname: Tsuzuki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Okada
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Kawahara
authors.forename: Ryuta
authors.initials: R
authors.lastname: Takenaka
authors.forename: Junichiro
authors.initials: J
authors.lastname: Nasu
authors.forename: Hidehiko
authors.initials: H
authors.lastname: Ishioka
authors.forename: Akiko
authors.initials: A
authors.lastname: Fujiwara
authors.forename: Fumiya
authors.initials: F
authors.lastname: Yoshinaga
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Yamamoto
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy / Q000209:etiology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D004334:Drug Administration Schedule; D004415:Dyspepsia / Q000188:drug therapy / Q000209:etiology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006356:Heartburn / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D009853:Omeprazole / Q000008:administration & dosage*; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D011788:Quality of Life; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole