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Normal and Proton Pump Inhibitor-Mediated Gastrin Levels in Infants 1-11 Months of Age.
MedLine Citation:
PMID:  23689261     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND:: Scant data exist on the normal range of serum gastrin in infants. In phase I and III trials of rabeprazole in gastroesophageal reflux disease (GERD), we studied serum gastrin levels in infants 1-11 months old, and assessed normal ranges and the effect of acid-suppressive drugs. METHODS:: Overall, 349 treatment naïve or treatment-experienced (previously exposed to proton pump inhibitors [PPIs] and/or H2-receptor antagonists [H2RAs]) infants with GERD were screened for baseline serum gastrin. Repeat gastrin was monitored at early termination or end of study (EOS), allowing assessment of 1-8 week daily rabeprazole (5- or 10-mg) treatment on gastrin levels. RESULTS:: Median (5%-95% range) baseline gastrin was 118 (39-315) ng/L in the treatment-naïve group (n = 251), driven mostly by high levels (121.5 [48-326] ng/L) in the 1-<4 month old subgroup. Treatment-experienced infants (n = 98) had elevated baseline gastrin levels (152 [48-487] ng/L; P = 0.0011) with no clear difference between previously PPI-exposed and H2RA-exposed groups. At EOS, mean (SD) levels were unchanged from baseline in infants withdrawn from rabeprazole to placebo (124 [94] ng/L), but elevated from baseline in those continuing treatment with 5-mg (245 [151] ng/L) and 10-mg (332 [222] ng/L) rabeprazole during the study. CONCLUSION:: Gastrin levels in treatment-naïve infants were elevated through 8 months of age. Between 8 and 12 months of age, they declined so that the median level was within the upper limit of the normal adult range (<100 ng/L). Previous exposure to acid suppressive medications and short-term exposure to rabeprazole significantly increased gastrin levels in infants <1 year old.
Authors:
William Treem; Peter Hu; Sheldon Sloan
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-5-16
Journal Detail:
Title:  Journal of pediatric gastroenterology and nutrition     Volume:  -     ISSN:  1536-4801     ISO Abbreviation:  J. Pediatr. Gastroenterol. Nutr.     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-5-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8211545     Medline TA:  J Pediatr Gastroenterol Nutr     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Janssen Research & Development, LLC, Titusville, NJ, USA.
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