Critical examination of therapeutic efficacy of a pH-sensitive enteric-coated pancreatic enzyme preparation in treatment of exocrine pancreatic insufficiency secondary to cystic fibrosis.

In an attempt to critically examine the therapeutic efficacy of pH-sensitive enteric-coated pancreatic enzyme preparations in patients with pancreatic insufficiency due to cystic fibrosis, postprandial duodenal concentration and recovery of orally administered pancreatic enzymes, duodenal pH, and coefficient of fat absorption were determined in eight cases after ingestion of equivalent dosage of enteric-coated as well as conventional enzyme preparations. Ingestion of a pH-sensitive enteric-coated pancreatic enzyme preparation was accompanied with a significant (P less than 0.05) reduction in steatorrhea, as well as a lower mean concentration and recovery of lipase and trypsin activity in the postprandial duodenal samples. Furthermore, the intraluminal duodenal pH was noted to be below 4.0 during the postprandial period in all patients. These data suggest that in cystic fibrosis, the greater therapeutic efficacy of pH-sensitive enteric-coated preparations over conventional preparations may be related to the protection of pancreatic enzymes from the highly acidic milieu in the duodenum, allowing for possible bioavailability in the distal small intestine.