Clinical trial: factors associated with freedom from relapse of heartburn in patients with healed reflux oesophagitis--results from the maintenance phase of the EXPO study

Aliment Pharmacol Ther. 2009 Jun 1;29(11):1165-71. doi: 10.1111/j.1365-2036.2009.03990.x. Epub 2009 Mar 2.

Abstract

Background: Ability to predict freedom from heartburn relapse during maintenance therapy for healed reflux oesophagitis may facilitate optimal treatment choices for individual patients.

Aim: To determine factors predicting freedom from heartburn relapse during maintenance proton pump inhibitor therapy in patients with healed reflux oesophagitis.

Methods: This post-hoc analysis used data from the maintenance phase of the EXPO study (AstraZeneca study code: SH-NEG-0008); 2766 patients with healed reflux oesophagitis and resolved heartburn received once-daily esomeprazole 20 mg or pantoprazole 20 mg for 6 months. Multiple logistic regression analysis determined factors associated with freedom from heartburn relapse.

Results: Heartburn relapse rates were lower with esomeprazole than pantoprazole in all subgroups analysed. Esomeprazole treatment was the factor most strongly associated with freedom from heartburn relapse (odds ratio 2.08; P < 0.0001). Other factors significantly associated with freedom from heartburn relapse were Helicobacter pylori infection, greater age, non-obesity, absence of epigastric pain at baseline, pre-treatment nonsevere heartburn and GERD symptom duration < or =5 years.

Conclusions: Several factors predict freedom from heartburn relapse during maintenance proton pump inhibitor therapy for healed reflux oesophagitis, the strongest being choice of proton pump inhibitor. These findings outline the importance of optimizing acid control and identifying predictors of relapse for effective long-term symptom management in reflux oesophagitis patients.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage*
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Ulcer Agents / therapeutic use*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Esomeprazole / administration & dosage*
  • Esophagitis, Peptic / drug therapy*
  • Female
  • Heartburn / prevention & control*
  • Humans
  • Male
  • Middle Aged
  • Pantoprazole
  • Proton Pump Inhibitors / therapeutic use*
  • Regression Analysis
  • Secondary Prevention
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Proton Pump Inhibitors
  • Pantoprazole
  • Esomeprazole