title: Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy.
abstract: OBJECTIVE
  Approximately 20-30% of patients with gastroesophageal reflux disease (GERD) do not experience complete symptom resolution during proton pump inhibitor (PPI) therapy. The aim of this study was to determine the prevalence of esophageal mucosal breaks among patients who have a partial response to PPI therapy.
  
  
  METHODS
  This was an analysis of data from a phase 2b clinical trial carried out to assess the efficacy and safety of a reflux inhibitor, lesogaberan (AZD3355), as an add-on to PPI therapy in this patient population (clinicaltrials.gov reference: NCT01005251). A total of 661 patients with persistent GERD symptoms who had received a minimum of 4 weeks of PPI therapy were included in the study. The prevalence of esophageal mucosal breaks was assessed according to (i) the most recent endoscopy results from within the previous 24 months, if available ("historical" endoscopies), and (ii) the results of endoscopies performed at study baseline ("baseline" endoscopies). Baseline endoscopies were not carried out in patients who had a historical endoscopy showing an absence of esophageal mucosal breaks.
  
  
  RESULTS
  Historical endoscopy results were available for 244 patients, of whom 48 (19.7%) had esophageal mucosal breaks. Baseline endoscopies were carried out in 465 patients, of whom 146 (31.4%) had esophageal mucosal breaks. Sensitivity analyses showed a prevalence of esophageal mucosal breaks of 20-30%. In both the historical and baseline endoscopies, most esophageal mucosal breaks were Los Angeles grades A or B.
  
  
  CONCLUSIONS
  In patients with GERD symptoms partially responsive to PPI therapy, mild-to-moderate severity esophageal mucosal breaks are common (prevalence 20-30%), and may contribute to symptom etiology.
authors: Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7080, USA. nshaheen@med.unc.edu
authors: Nicholas J
authors: NJ
authors: Shaheen
authors: Hans
authors: H
authors: Denison
authors: Karin
authors: K
authors: Björck
authors: Debra G
authors: DG
authors: Silberg
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D004724:Endoscopy; D004942:Esophagitis, Peptic / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology*; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010721:Phosphinic Acids / Q000627:therapeutic use*; D015995:Prevalence; D011437:Propylamines / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D010721:Phosphinic Acids; D011437:Propylamines; D054328:Proton Pump Inhibitors; C545087:lesogaberan