Children and adults with cystic fibrosis with exocrine pancreatic insufficiency.
Interventions
Pancreatic enzyme replacement therapy (PERT). Enteric-coated (EC) bicarbonate-buffered PERT product (PERTZYE/PANCRECARB; Digestive Care, Inc., Bethlehem, PA, USA). 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.
Outcome measures
Mean coefficient of fat absorption; nitrogen absorption were observed; stool frequency and stool weight decreased. Safety
Main results
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.
Authors' conclusions
EC-bicarbonate- buffered PERT is effective in treating cystic fibrosis-associated exocrine pancreatic insufficiency.