Long-term effect on symptoms and quality of life of maintenance therapy with esomeprazole 20 mg daily: A post hoc analysis of the LOTUS trial

Lars Lundell, Jan Hatlebakk, Jean Paul Galmiche, Stephen E. Attwood, Christian Ell, Roberto Fiocca, Tore Persson, Péter Nagy, Stefan Eklund, Tore Lind

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To assess the long-term effect on symptoms and quality of life of esomeprazole 20 mg once daily, a recommended dose for maintenance therapy of gastroesophageal reflux disease (GERD).

Research design and methods: This is a post hoc analysis of 5 year data from patients in the LOTUS trial (ClinicalTrials.gov identifier: NCT00251927) who were randomized to esomeprazole 20 mg once daily. All participants had chronic, symptomatic GERD responsive to treatment. Gastrointestinal symptoms were assessed by physicians and by using patient-reported outcome instruments. Investigations included gastrointestinal endoscopy (with biopsy sampling), 24 hour esophageal pH monitoring and laboratory measurements.

Results: In total, 157 of 256 patients randomized to esomeprazole 20 mg once daily remained on this dose until the end of follow-up or study discontinuation, whereas 99 patients had their dose increased because of inadequate symptom control (of these, 29 subsequently returned to the allocated dose). On logistic regression, a long objectively defined GERD history, smoking, female sex, absence of Helicobacter pylori infection and high supine baseline acid reflux into the esophagus were associated with an increased likelihood of requiring dose escalation to esomeprazole 40 mg daily (all p <0.05). Symptoms were fairly stable and quality of life was normal throughout follow-up in patients remaining on esomeprazole 20 mg once daily, with no more than mild symptom severity, and mean (standard deviation) percentage time with intraesophageal pH

Limitations: Post hoc analysis with no control group.

Conclusions: Esomeprazole at a maintenance dose of 20 mg once daily offers effective long-term treatment for chronic GERD in patients initially responsive to the medication, with durable symptom control and sustained reductions in intraesophageal acid exposure.

Original languageEnglish
Article number980500
Pages (from-to)65-73
Number of pages9
JournalCurrent Medical Research and Opinion
Volume31
Issue number1
DOIs
Publication statusPublished - Jan 1 2015

Keywords

  • Enterochromaffin cells
  • Gastritis
  • Gastroesophageal reflux
  • Helicobacter pylori
  • Long-term care
  • Proton pump inhibitors
  • Safety

ASJC Scopus subject areas

  • Medicine(all)

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