title: Retrospective analysis to investigate the effect of concomitant use of gastric acid-suppressing drugs on the efficacy and safety of pancrelipase/pancreatin (CREON®) in patients with pancreatic exocrine insufficiency.
abstract: OBJECTIVE
  This study aimed to determine whether the efficacy of pancrelipase/pancreatin (CREON®) may be affected by the concomitant use of proton pump inhibitors (PPIs)/histamine-2 receptor antagonists (H2RAs).
  
  
  METHODS
  An analysis of integrated data from all clinical trials of pancrelipase/pancreatin supported by Abbott (34 trials, 1142 unique subjects) was conducted. All trials included patients with pancreatic exocrine insufficiency, and most cases were associated with cystic fibrosis, chronic pancreatitis, or pancreatic surgery. Study designs included single and double blind, open label, parallel group, and crossover, and most were randomized. The primary end point for this analysis was on-treatment coefficient of fat absorption (CFA) according to concomitant PPI/H2RA use (yes/no).
  
  
  RESULTS
  There were no meaningful differences in mean CFA values at the end of pancrelipase/pancreatin treatment by concomitant PPI/H2RA use: yes (n = 254), 82.7% versus no (n = 449), 84.2%. No meaningful differences were observed when the same analysis was carried out by disease type (cystic fibrosis, chronic pancreatitis, and pancreatic surgery).
  
  
  CONCLUSIONS
  This analysis of data from clinical trials enrolling patients with pancreatic exocrine insufficiency suggests that the efficacy of pancrelipase/pancreatin is not affected by concomitant PPI/H2RA use, as determined by end-of-treatment CFA values, and supports the treatment guidelines' recommendation that acid suppression is not routinely required with pancreatic enzyme replacement therapy.
authors.affiliation: Enzymes/GI Clinical Development, Established Pharmaceuticals EPD, Abbott Products GmbH, Hannover, Germany. suntje.sander@abbott.com
authors.forename: Suntje
authors.initials: S
authors.lastname: Sander-Struckmeier
authors.forename: Katrin
authors.initials: K
authors.lastname: Beckmann
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: Janssen-van Solingen
authors.forename: Paul
authors.initials: P
authors.lastname: Pollack
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D020799:Pancrelipase / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005765:Gastrointestinal Agents; D020799:Pancrelipase