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Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data

OBJECTIVES: 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...

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Autores principales: Metz, David C, Pilmer, Betsy L, Han, Cong, Perez, M Claudia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209587/
https://www.ncbi.nlm.nih.gov/pubmed/21844923
http://dx.doi.org/10.1038/ajg.2011.220
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author Metz, David C
Pilmer, Betsy L
Han, Cong
Perez, M Claudia
author_facet Metz, David C
Pilmer, Betsy L
Han, Cong
Perez, M Claudia
author_sort Metz, David C
collection PubMed
description OBJECTIVES: 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.
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spelling pubmed-32095872011-11-29 Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data Metz, David C Pilmer, Betsy L Han, Cong Perez, M Claudia Am J Gastroenterol Esophagus OBJECTIVES: 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. Nature Publishing Group 2011-11 2011-08-16 /pmc/articles/PMC3209587/ /pubmed/21844923 http://dx.doi.org/10.1038/ajg.2011.220 Text en Copyright © 2011 American College of Gastroenterology http://creativecommons.org/licenses/by-nc-nd/3.0/ This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/
spellingShingle Esophagus
Metz, David C
Pilmer, Betsy L
Han, Cong
Perez, M Claudia
Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data
title Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data
title_full Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data
title_fullStr Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data
title_full_unstemmed Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data
title_short Withdrawing PPI Therapy After Healing Esophagitis Does Not Worsen Symptoms or Cause Persistent Hypergastrinemia: Analysis of Dexlansoprazole MR Clinical Trial Data
title_sort withdrawing ppi therapy after healing esophagitis does not worsen symptoms or cause persistent hypergastrinemia: analysis of dexlansoprazole mr clinical trial data
topic Esophagus
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3209587/
https://www.ncbi.nlm.nih.gov/pubmed/21844923
http://dx.doi.org/10.1038/ajg.2011.220
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