High-dose esomeprazole for treatment of symptomatic refractory gastroesophageal reflux disease--a prospective pH-metry/impedance-controlled study

Digestion. 2009;80(2):112-8. doi: 10.1159/000221146. Epub 2009 Jul 27.

Abstract

Background/aims: Combined pH-metry/multichannel intraluminal impedance (pH/MII) measurement enables to measure gastroesophageal reflux despite ongoing proton pump inhibitor therapy. The aim of our study was to evaluate the influence of an escalating medical anti-reflux therapy with 40 mg esomeprazole, 80 mg esomeprazole and 80 mg esomeprazole plus baclofen for the treatment of refractory pathological reflux as determined by pH/MII.

Methods: Symptomatic patients under 40 mg esomeprazole were screened by pH/MII. Patients with normal values in pH/MII were excluded; all others received 2 x 40 mg esomeprazole for another 4 weeks. Thereafter, the treatment effect was controlled by pH/MII. In the case of persistent pathological reflux, therapy was further escalated by adding baclofen and controlled after 3 months by pH/MII.

Results: 45/138 (32.6%) patients showed pathological pH/MII despite ongoing therapy with 40 mg esomeprazole. In these, a significant reduction in liquid/mixed reflux events was observed after administering 2 x 40 mg (mean: 118.3 vs. mean: 66.6; p < 0.001), and pH/MII turned to normal in 32/45 (71.1%). Baclofen was additionally administered to 7/13 patients, which did not lead to a remarkable reduction in reflux events.

Conclusion: In patients with abnormal pH/MII and persistent symptoms under 40 mg esomeprazole, we observed a significant reduction in liquid/mixed reflux events after increasing proton pump inhibitor dose up to 80 mg esomeprazole. Further escalation of therapy with baclofen has shown inconclusive results.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Baclofen / administration & dosage
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Electric Impedance
  • Esomeprazole / administration & dosage*
  • Esophageal Sphincter, Lower
  • Esophageal pH Monitoring
  • Female
  • GABA Agonists / administration & dosage
  • Gastroesophageal Reflux / complications
  • Gastroesophageal Reflux / diagnosis*
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Proton Pump Inhibitors / administration & dosage*
  • Treatment Outcome
  • Young Adult

Substances

  • GABA Agonists
  • Proton Pump Inhibitors
  • Baclofen
  • Esomeprazole