Lean body weight dosing avoids excessive systemic exposure to proton pump inhibitors for children with obesity

Pediatr Obes. 2019 Jan;14(1):10.1111/ijpo.12459. doi: 10.1111/ijpo.12459. Epub 2018 Sep 26.

Abstract

Background: Children with obesity are more likely to suffer gastroesophageal reflux disease, requiring acid-suppression therapy with proton pump inhibitors (PPIs) and no guidelines regarding dosing.

Objective: To prospectively evaluate lean-body-weight-based (LBW) dosing of the PPI pantoprazole for children with and without obesity.

Methods: Methods: Sixty-two children (6-17 years) received a one-time oral dose of liquid pantoprazole (1.2 mg kg-1 LBW). Plasma pantoprazole concentrations were measured at 10 time points over 8 h and pharmacokinetic (PK) profiles generated using non-compartmental techniques, in order to compare PK parameters of interest between children with and without obesity, while accounting for CYP2C19 genotype.

Results: Adjusted for milligram-per-kilogram total body weight (TBW) pantoprazole received, apparent drug clearance (CL/F) was reduced 50% in children with vs. without obesity (p=0.03). LBW-based dosing compensated for this reduction in CL/F (p = 0.15).

Conclusion: To achieve comparable systemic PPI exposures for children with and without obesity, we recommend using LBW, rather than TBW-based dosing for pantoprazole.

Trial registration: ClinicalTrials.gov NCT01887743.

Keywords: CYP2C19; drug metabolism; pantoprazole; pediatric obesity.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Body Weight / drug effects*
  • Child
  • Cytochrome P-450 CYP2C19 / genetics
  • Drug Dosage Calculations
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / etiology
  • Genotype
  • Humans
  • Male
  • Pantoprazole / administration & dosage*
  • Pantoprazole / pharmacokinetics
  • Pediatric Obesity / complications*
  • Pediatric Obesity / drug therapy
  • Prospective Studies
  • Proton Pump Inhibitors / administration & dosage*
  • Proton Pump Inhibitors / pharmacokinetics

Substances

  • Proton Pump Inhibitors
  • Pantoprazole
  • CYP2C19 protein, human
  • Cytochrome P-450 CYP2C19

Associated data

  • ClinicalTrials.gov/NCT01887743