title: The pharmacodynamic effect of omeprazole 10 mg and 20 mg once daily in patients with nonerosive reflux disease in Japan.
abstract: BACKGROUND
  To evaluate the pharmacodynamic effect, efficacy, and safety of omeprazole 10 mg and 20 mg once daily in patients with nonerosive reflux disease (NERD) in Japan.
  
  
  METHODS
  A total of 37 patients were randomized to omeprazole 10 mg or omeprazole 20 mg once daily for 4 weeks. Eligible patients had a history of moderate-to-severe heartburn for 2 days or more per week during the last 1 month or longer prior to the study screening, grade M or grade N on Hoshihara's modification of the Los Angeles classification (i.e., no sign of mucosal break on esophagogastroduodenoscopy), and heartburn episodes for 2 days or more per week during the last week of the observation period while taking antacids. Ambulatory 24-h intraesophageal pH was monitored on the day before treatment and on the last day of treatment. The occurrence of a heartburn episode was recorded during pH monitoring. The primary endpoint was the change in the percentage of time with intraesophageal pH < 4 during the 24-h period before and after omeprazole treatment.
  
  
  RESULTS
  Both omeprazole 10 mg and omeprazole 20 mg once daily reduced the percentage of time with intraesophageal pH < 4. The percentage reduction in time with intraesophageal pH < 4 after treatment with omeprazole was associated with a reduced number of heartburn episodes. Patients with grade M or grade N esophagus had similar pH profiles and NERD characteristics (e.g., pH holding time, symptom index) and comparable responses to omeprazole. No serious, drug-related adverse events were reported.
  
  
  CONCLUSIONS
  Omeprazole 10 mg or 20 mg reduces the percentage of time with intraesophageal pH < 4, is efficacious, and is well tolerated in patients with NERD in Japan, regardless of the patient's endoscopic classification.
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, 693-8501, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
authors.forename: Takeaki
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Kato
authors.forename: Kan
authors.initials: K
authors.lastname: Asahina
authors.forename: Ken
authors.initials: K
authors.lastname: Haruma
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Shimatani
authors.forename: Shuji
authors.initials: S
authors.lastname: Inoue
authors.forename: Teppei
authors.initials: T
authors.lastname: Kabemura
authors.forename: Susumu
authors.initials: S
authors.lastname: Kurosawa
authors.forename: Hajime
authors.initials: H
authors.lastname: Kuwayama
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ashida
authors.forename: Michiaki
authors.initials: M
authors.lastname: Hirayama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kiyama
authors.forename: Munemitsu
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Junichi
authors.initials: J
authors.lastname: Suzuki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Suzuki
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Masaru
authors.initials: M
authors.lastname: Aoshima
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D054328:Proton Pump Inhibitors
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole