Helicobacter pylori treatment in children: Defining a dose for rabeprazole as a part of a triple therapy regimen. (4th February 2015)

• Record Type: Journal Article
• Authors: Kimko, Holly; Thyssen, An; Mould, Diane R.; Mannaert, Erik; Treem, William R.
• Is Part Of: Journal of clinical pharmacology. Volume 55:Number 5(2015:May)
• Page Start: 592
• Page End: 600
• Publication Date: 2015-02-04
• Subjects: Pharmacology -- Periodicals; Pharmacology -- Periodicals; Pharmacology, Clinical -- Periodicals; 615.1
• DOI: 10.1002/jcph.457
• Languages: English
• ISSNs: 0091-2700

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <sec id="jcph457-sec-0001" sec-type="section"> <p>The proton pump inhibitor, rabeprazole, has been studied in children for the treatment of gastroesophageal reflux disease (GERD). In adults, rabeprazole is indicated for <italic>Helicobacter pylori</italic> eradication in combination with amoxicillin and clarithromycin. Nonlinear mixed effects modeling was conducted to estimate pharmacokinetic (PK) parameters for rabeprazole and its thioether metabolite from 336 subjects, 35% of whom were children 1–11 years with GERD from phase I and III studies. A 2‐compartment disposition model with a transit absorption model provided the best fit for rabeprazole PK. The steady‐state area under the concentration‐time curves given several candidate doses were simulated to identify a dose per each body weight group that is comparable to a 20 mg twice‐daily dose in adults, which is the recommended dose for treatment of <italic>H. pylori</italic> in adults. Simulations provided the following recommended twice‐daily weight‐based doses for children ≥1 year and &lt;16 years: 10 mg for 6–10 kg, 15 mg for 10–30 kg, and 20 mg for ≥30 kg.</p> </sec> </abstract>