title: Pantoprazole rapidly improves health-related quality of life in patients with heartburn: a prospective, randomized, double blind comparative study with nizatidine.
abstract: BACKGROUND
  Health-related quality of life (HRQoL) is impaired in untreated patients with gastroesophageal reflux disease (GERD). In the absence of an objective marker such as erosions, assessment of treatment efficacy can be based on symptoms and HRQoL.
  
  
  OBJECTIVE
  To evaluate changes in HRQoL during treatment with pantoprazole or nizatidine in patients with GERD.
  
  
  METHODS
  This was a prospective, randomized, double blind Canadian multicenter study. Patients with GERD, characterized by heartburn that had occurred 4 or more times per week for at least 6 months, were treated for 28 days with either pantoprazole 40 mg once daily or nizatidine 150 mg twice daily. HRQoL assessment was performed before endoscopy (baseline) and on days 7 and 28 after treatment. HRQoL was assessed using 4 domains of the SF-36, the SF-12 summary scales and the gastrointestinal system rating scale (GSRS).
  
  
  RESULTS
  A total of 208 patients (n = 106 pantoprazole treatment group, n = 102 nizatidine treatment group) was available for intention-to-treat analysis. Baseline HRQoL scores were comparable between the 2 treatment groups. After 7 days, treatment with pantoprazole led to a statistically significant greater improvement in HRQoL in 2 SF-36 domains: bodily pain (pantoprazole versus nizatidine, P = 0.0088) and vitality (pantoprazole versus nizatidine, P = 0.0137), and in the GSRS reflux score (pantoprazole versus nizatidine, P = 0.0078). After 28 days of treatment, the changes in scores relative to baseline were still greater with pantoprazole than with nizatidine. The improvement in the 4 SF-36 domains and the GSRS reflux score achieved by pantoprazole after 7 days were also significantly greater than those achieved by nizatidine after 28 days.
  
  
  CONCLUSIONS
  HRQoL improves more rapidly and to a greater degree following treatment with pantoprazole than nizatidine. Control of heartburn strongly predicts HRQoL improvement during the acute treatment of GERD. Our data support the approach to use pantoprazole instead of nizatidine as the initial therapy for patients with heartburn in a primary care practice setting.
authors.affiliation: Hôpital St-Sacrement, Division of Gastroenterology, 1050, Chemin Ste-Foy, Québec G1S 4L8, Canada. pierre.pare@cha.quebec.qc.ca
authors.forename: Pierre
authors.initials: P
authors.lastname: Paré
authors.forename: David
authors.initials: D
authors.lastname: Armstrong
authors.forename: Dan
authors.initials: D
authors.lastname: Pericak
authors.forename: Myron
authors.initials: M
authors.lastname: Pyzyk
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D004311:Double-Blind Method; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000209:etiology; D006305:Health Status Indicators; D006356:Heartburn / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D016567:Nizatidine / Q000627:therapeutic use; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D011788:Quality of Life; D013454:Sulfoxides / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole; D016567:Nizatidine