title: Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: final results of OMAREE, a large-scale clinical experience investigation.
abstract: BACKGROUND
  For patients with reflux esophagitis (RE), endoscopic findings alone (without the frequency and severity of symptoms) may not fully reflect the associated impact on health-related quality of life (QOL). There is not enough data about symptoms and QOL of Japanese patients with RE. The present study therefore investigated the epidemiological characteristics of such patients, and evaluated the efficacy and safety of omeprazole (and other gastrointestinal drugs, except proton pump inhibitors [PPIs]) in terms of improving patients' symptoms and QOL.
  
  
  METHODS
  In a large-scale, specific clinical experience investigation of Japanese patients with RE, epidemiological characteristics, QOL and symptoms of the disease in relation to treatment with omeprazole and other gastrointestinal drugs, except PPIs, and safety data of omeprazole were collected. The Quality Of Life in Reflux and Dyspepsia questionnaire (QOLRAD) was used for QOL assessment.
  
  
  RESULTS
  9967 patients were included in the analysis (omeprazole: 7888). At baseline, 75.2% of patients had three or more upper gastrointestinal symptoms, and 31.5% of patients had six or more upper gastrointestinal symptoms. The overall mean QOLRAD score at baseline was 5.14 (the best score is 7). In the omeprazole group, the rate of satisfactory improvement in subjective symptoms was 61.7% and 81.8% at Weeks 4 and 8, respectively, and these were both significantly higher than those of patients treated with other drugs. In both the omeprazole group and the other drugs group, the QOLRAD score at Week 4 improved significantly from baseline, and the degree of improvement was significantly greater in the omeprazole group than in the other drugs group. The favourable tolerability profile of omeprazole was confirmed.
  
  
  CONCLUSIONS
  In a large-scale survey, omeprazole improved symptoms and QOL more effectively in Japanese patients with RE than other investigated drugs, and had a good tolerability profile.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00859287.
authors.affiliation: Research & Development, AstraZeneca K,K, 1-1-88 Ohyodo-naka, Kita-ku, Osaka 531-0076, Japan. shigeru.yoshida@astrazeneca.com
authors.forename: Shigeru
authors.initials: S
authors.lastname: Yoshida
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nii
authors.forename: Masataka
authors.initials: M
authors.lastname: Date
mesh_terms: D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006306:Health Surveys; D006801:Humans; D007564:Japan; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D009853:Omeprazole