title: Withdrawing PPI therapy after healing esophagitis does not worsen symptoms or cause persistent hypergastrinemia: analysis of dexlansoprazole MR clinical trial data.
abstract: OBJECTIVE
  Withdrawal of proton pump inhibitors (PPIs) may induce symptoms in healthy volunteers, suggesting that discontinuing PPI therapy induces acid-peptic disease. Similar assessments in patients with documented acid-related disorders are lacking.
  
  
  METHODS
  We performed a retrospective analysis of data from 287 Helicobacter pylori-negative erosive esophagitis (EE) patients healed after 4 or 8 weeks of therapy with dexlansoprazole modified release (MR) or lansoprazole, and then randomized to placebo in 6-month maintenance trials. We compared serum gastrin levels and 24-h heartburn severity before enrollment in the healing trials (baseline) and after receiving placebo in the 6-month maintenance trials.
  
  
  RESULTS
  Mean gastrin values at maintenance months 1 and 3 were essentially unchanged (median changes, 1.0 and -1.0 pg/ml), showing that gastrin normalized within 1 month of discontinuing PPIs and remained flat. Mean heartburn severity at maintenance month 1 was <1 on a 5-point scale (1=mild) and significantly lower than at baseline (median decrease, 0.41 points; P≤0.001). Heartburn severity in patients healed at week 4 or 8 with either PPI was generally similar, suggesting that neither longer exposure nor more potent therapy was associated with rebound. In those with month 2 data, mean heartburn severity at months 1 and 2 was significantly lower than baseline (median decrease, 0.54 and 0.58 points; both P<0.001), indicating an ongoing symptom response for 2 months after PPI withdrawal.
  
  
  CONCLUSIONS
  In H. pylori-negative EE patients, there was no indication of recurring heartburn symptom worsening beyond baseline levels within 2 months of discontinuing 4-8 weeks of PPI therapy.
authors.affiliation: Division of Gastroenterology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-4283, USA. David.Metz@uphs.upenn.edu
authors.forename: David C
authors.initials: DC
authors.lastname: Metz
authors.forename: Betsy L
authors.initials: BL
authors.lastname: Pilmer
authors.forename: Cong
authors.initials: C
authors.lastname: Han
authors.forename: M Claudia
authors.initials: MC
authors.lastname: Perez
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D064748:Dexlansoprazole; D004941:Esophagitis / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005744:Gastric Acid / Q000378:metabolism; D005755:Gastrins / Q000097:blood*; D006356:Heartburn / Q000209:etiology; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012720:Severity of Illness Index; D028761:Withholding Treatment
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D005755:Gastrins; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D064748:Dexlansoprazole