Enteric-coated pancreatic enzyme with bicarbonate is equal to standard enteric-coated enzyme in treating malabsorption in cystic fibrosis.
OBJECTIVE
To compare the efficacy of an enteric-coated buffered pancreatic enzyme (EC buffered PE) containing 1.5 mEq of bicarbonate per capsule with a conventional enteric-coated enzyme (EC-PE) capsule in cystic fibrosis patients with signs or symptoms of moderate to severe malabsorption.


METHODS
In a double-blind crossover study, subjects were randomly assigned to two consecutive, 2-week phases using an EC buffered PE product and conventional EC-PE product. Seventy-two hour stool collections from each phase were analyzed for energy, fat, and nitrogen content and expressed as percent of estimated intake.


RESULTS
Twenty-one patients with cystic fibrosis and pancreatic insufficiency (14 female, mean age 20.6 +/- 11.5 years, range 8.8-41.9) completed the study. There was no significant difference in percent malabsorption of energy (19.4% vs. 19.0%), fat (20.7% vs. 20.2%), or nitrogen (10.4% vs. 10.7%) between the EC buffered PE product and the conventional EC-PE product. However, patients taking the EC buffered PE product received less enzyme based on actual enzyme activity measured in vitro (3,468 +/- 1,434 U lipase/g fat vs. 3,978 +/- 1,474 U lipase/g fat, P < 0.02).


CONCLUSIONS
In the doses used, nutrient absorption of patients taking EC buffered PE preparation offers no advantage over a conventional EC-PE preparation.
Division of Respiratory Medicine, Department of Pediatrics, The Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada.
Daina
D
Kalnins
Lynda
L
Ellis
Mary
M
Corey
Paul B
PB
Pencharz
Cynthia
C
Stewart
Elizabeth
E
Tullis
Peter R
PR
Durie
D000293:Adolescent; D000328:Adult; D001639:Bicarbonates / Q000494:pharmacology; D002648:Child; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000150:complications*; D004311:Double-Blind Method; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000201:enzymology; D005243:Feces / Q000737:chemistry*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D050356:Lipid Metabolism; D008286:Malabsorption Syndromes / Q000188:drug therapy* / Q000201:enzymology; D008297:Male; D009584:Nitrogen / Q000032:analysis; D020799:Pancrelipase / Q000627:therapeutic use*; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
D001639:Bicarbonates; D005765:Gastrointestinal Agents; D013608:Tablets, Enteric-Coated; D020799:Pancrelipase; D009584:Nitrogen