Acid control cannot be improved with a modified-release formulation of a proton pump inhibitor compared with twice-daily dosing of the conventional formulation

Dig Dis Sci. 2010 Dec;55(12):3423-9. doi: 10.1007/s10620-010-1176-7. Epub 2010 Mar 18.

Abstract

Aim: The aim of this study was to compare acid control with a once-daily (od) modified-release (MR) formulation of esomeprazole vs. the conventional formulation (CF) dosed twice-daily (bid).

Methods: In a randomized, five-way crossover study, 55 healthy volunteers underwent 24-h intragastric pH monitoring after 5-day treatment with MR esomeprazole (40, 60 or 80 mg od) and CF esomeprazole (20 or 40 mg bid).

Results: Modified-release 60 and 80 mg od resulted in a significantly longer time with intragastric pH > 4 than MR 40 mg od (77.1 and 79.0% vs. 66.4%, respectively; both p < 0.05). At equivalent total daily doses, CF 20 mg bid led to a significantly longer time with intragastric pH > 4 than MR 40 mg od (72.3 vs. 66.4%; p < 0.05), and CF 40 mg bid led to a significantly longer time with pH > 4 than MR 80 mg od (85.5 vs. 79.0%; p < 0.05).

Conclusions: At equivalent total daily doses, the MR formulation of esomeprazole provides less 24-h acid control than the conventional formulation dosed twice-daily.

Publication types

  • Clinical Trial, Phase I
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cross-Over Studies
  • Delayed-Action Preparations
  • Esomeprazole / administration & dosage*
  • Esomeprazole / pharmacokinetics
  • Female
  • Gastric Acid / metabolism*
  • Gastroesophageal Reflux / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Proton Pump Inhibitors / administration & dosage*
  • Proton Pump Inhibitors / pharmacokinetics

Substances

  • Delayed-Action Preparations
  • Proton Pump Inhibitors
  • Esomeprazole