An enteric-coated high-buffered pancrelipase reduces steatorrhea in patients with cystic fibrosis: a prospective, randomized study.
OBJECTIVE
Enteric-coated (EC) high-buffered (2.5 mEq [2.5 mmol] bicarbonate per capsule) pancrelipase microsphere enzymes were compared to EC-nonbuffered pancreatic enzymes for efficacy in reducing steatorrhea in patients with cystic fibrosis.


METHODS
Prospective, randomized, controlled trial using a crossover design with each subject as his/her own control.


METHODS
Eighteen subjects with cystic fibrosis, who had pancreatic insufficiency and required large enzyme doses, were studied over two consecutive 7-day treatment periods.


METHODS
Each 7-day period consisted of 3 days at home followed by 4 days in a general clinical research center for careful control of diets, enzyme lipase doses (given at approximately 50% of the subject's usual lipase dose), and carmine red-labeled stool collections for 72-hour fecal fat balance studies.


METHODS
Fecal fat excretion.


METHODS
Differences in fat excretion, when each subject received EC-high-buffered pancrelipase vs EC-nonbuffered enzymes, were compared using linear modeling.


RESULTS
Mean fat excretion decreased significantly in each subject during periods when given EC-high-buffered pancrelipase compared with periods when given EC-nonbuffered enzymes (fat excretion 18.2% vs 24.9% or fat absorption 81.8% vs 75.1%, respectively; P=0.01). Thirteen of 18 subjects (72%) excreted less fat when receiving EC-high-buffered pancrelipase whereas 10 (56%) decreased fat excretion by more than 5%, and five subjects did not respond.


CONCLUSIONS
EC-high-buffered pancrelipase decreased fat excretion, symbolizing improved fat absorption, when compared with EC-nonbuffered pancreatic enzymes given at equivalent, reduced (approximately 50% of usual) lipase doses in nourished subjects with cystic fibrosis and mild pulmonary disease.
Brady
Mary Sue
MS
Indiana University School of Health and Rehabilitation Sciences, Indianapolis, IN 46202-5119, USA. mabrady@iupui.edu
Garson
Jennifer L
JL
Krug
Susan K
SK
Kaul
Ajay
A
Rickard
Karyl A
KA
Caffrey
Helena Hoen
HH
Fineberg
Naomi
N
Balistreri
William F
WF
Stevens
John C
JC
D000293:Adolescent; D000328:Adult; D002648:Child; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000150:complications*; D004041:Dietary Fats / Q000378:metabolism*; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000201:enzymology; D005243:Feces / Q000737:chemistry; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D016014:Linear Models; D008297:Male; D008863:Microspheres; D020799:Pancrelipase / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D045602:Steatorrhea / Q000188:drug therapy* / Q000201:enzymology / Q000209:etiology; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
D004041:Dietary Fats; D005765:Gastrointestinal Agents; D013608:Tablets, Enteric-Coated; D020799:Pancrelipase