title: Efficacy and safety of a unique enteric-coated bicarbonate-buffered pancreatic enzyme replacement therapy in children and adults with cystic fibrosis.
abstract: BACKGROUND
  Pancreatic enzyme replacement therapy (PERT) is used to treat exocrine pancreatic insufficiency in cystic fibrosis.
  Efficacy and safety of a unique enteric-coated (EC) bicarbonate-buffered PERT product (PERTZYE®/PANCRECARB®; Digestive Care, Inc., Bethlehem, PA, USA) was studied in a randomized, double-blind, placebo-controlled cross-over design. Subjects were stabilized on EC-bicarbonate-buffered PERT and a high-fat diet. During two treatment periods, subjects were randomized to EC-bicarbonate-buffered PERT or placebo, followed by a 72-h stool collection employing an ingested stool dye marker. Mean coefficient of fat absorption with EC-bicarbonate-buffered PERT was 82.5% compared with 46.3% with the placebo (absolute difference 36.2%; p < 0.001), a 78.2% improvement for active over placebo. Similar improvements in nitrogen absorption were observed. Overall stool frequency and stool weight decreased (p < 0.001). No safety concerns were identified.
  
  
  CONCLUSIONS
  EC-bicarbonate-buffered PERT is effective in treating cystic fibrosis-associated exocrine pancreatic insufficiency.
authors.affiliation: Rainbow Babies & Children's Hospital & Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Konstan
authors.affiliation: Children's Hospital Colorado & University of Colorado Denver, Denver, CO, USA.
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Accurso
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: Samya Z
authors.initials: SZ
authors.lastname: Nasr
authors.affiliation: The University of Iowa Hospitals & Clinics, Iowa City, IA, USA.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Ahrens
authors.affiliation: The Pennsylvania State Milton S Hershey Medical Center, Hershey, PA, USA.
authors.forename: Gavin R
authors.initials: GR
authors.lastname: Graff
keywords: bicarbonate-buffered pancrelipase; coefficient of fat absorption; cystic fibrosis; exocrine pancreatic insufficiency; pancreatic enzyme replacement therapy