title: Management strategy for patients with gastroesophageal reflux disease: a comparison between empirical treatment with esomeprazole and endoscopy-oriented treatment.
abstract: OBJECTIVE
  Whether patients with typical gastroesophageal reflux disease (GERD) symptoms and without alarm features should be treated empirically or undergo endoscopy first is a debated issue. In this study, our aim was to assess the efficacy, and to compare the direct costs and impact on health-related quality of life (HRQL), of two treatment strategies (empirical vs endoscopy-oriented treatment) in a large population of patients with GERD.
  
  
  METHODS
  In total, 612 patients were randomized to either empirical treatment with esomeprazole 40 mg once daily (od) (group 1, N = 309) or endoscopy and treatment according to endoscopic findings (group 2, N = 303, esomeprazole 40 mg od in patients with reflux esophagitis and esomeprazole 20 mg od in patients without esophagitis) for 4 wk, followed by esomeprazole 20 mg od maintenance treatment in both groups. Direct costs and HRQL were analyzed in both treatment arms.
  
  
  RESULTS
  At the end of the acute treatment phase (week 4), 267 patients in group 1 (86.4%) and 265 patients in group 2 (87.5%) were considered responders to treatment (intention-to-treat analysis, P= 0.878). Empirical treatment proved to be cost-effective by saving 38.72 euros per treated patient. At the end of the maintenance phase (week 24), a similar proportion of patients responded to treatment in the two groups (71.8%vs 68.3%, P= 0.389). HRQL improved from baseline to week 24 in both groups (difference between study groups not significant).
  
  
  CONCLUSIONS
  In patients with GERD, empirical treatment with esomeprazole proved to be cost-effective compared with endoscopy-oriented treatment, and did not negatively affect patient HRQL. These results should be taken into account in the management of GERD patients in clinical practice.
authors.affiliation: Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy.
authors.forename: Edoardo G
authors.initials: EG
authors.lastname: Giannini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Zentilin
authors.forename: Pietro
authors.initials: P
authors.lastname: Dulbecco
authors.forename: Sergio
authors.initials: S
authors.lastname: Vigneri
authors.forename: Pamela
authors.initials: P
authors.lastname: Scarlata
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Savarino
mesh_terms: D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D003365:Costs and Cost Analysis; D064098:Esomeprazole / Q000627:therapeutic use*; D004945:Esophagoscopy; D005260:Female; D005764:Gastroesophageal Reflux / Q000191:economics / Q000628:therapy*; D005773:Gastroscopy; D006801:Humans; D008297:Male; D011788:Quality of Life
chemical_list: D000897:Anti-Ulcer Agents; D064098:Esomeprazole