Comparison of two enteric coated microsphere preparations in the treatment of pancreatic exocrine insufficiency caused by cystic fibrosis.
BACKGROUND
Pancreatic exocrine insufficiency is a common condition in patients with cystic fibrosis. Large amounts of pancreatic enzyme supplements are required to reduce malabsorption but patient compliance is not always optimal.


OBJECTIVE
To compare patients' preference and the efficacy of two enteric coated microsphere preparations in patients with cystic fibrosis.


METHODS
Patients with pancreatic exocrine insufficiency due to cystic fibrosis.


METHODS
Patients were assigned to the crossover treatment with Creon or Pancrease for 1 week and then to the alternative treatment. Patients had to follow a fixed diet (at least 2 g fat/kg) and had to assume 1000 units lipase/g fat. The evaluation parameters were: patients' preference, acceptance of therapy, stool fat excretion, stool weight, gastrointestinal symptoms, and tolerance.


CONCLUSIONS
Of the 33/60 patients who expressed a preference for one of the two treatments, 30 preferred Creon while only 3 patients preferred Pancrease (p<0.001). No difference between the two treatments was observed regarding stool characteristics, gastrointestinal symptoms and tolerance. The mean number of capsules taken daily was reduced by 35% with Creon. The results of this study showed a preference in favour of Creon probably due to the reduction of daily capsule intake of 35%, supporting digestion as well as Pancrease.
Santini
B
B
Department of Paediatric and Adolescence Science, University of Turin, Italy.
Antonelli
M
M
Battistini
A
A
Bertasi
S
S
Collura
M
M
Esposito
I
I
Di Febbraro
L
L
Ferrari
R
R
Ferrero
L
L
Iapichino
L
L
Lucidi
V
V
Manca
A
A
Pisconti
C L
CL
Pisi
G
G
Raia
V
V
Romano
L
L
Rosati
P
P
Grazioli
I
I
Melzi
G
G
D000293:Adolescent; D000328:Adult; D000681:Amylases / Q000008:administration & dosage; D002214:Capsules; D002648:Child; D003550:Cystic Fibrosis / Q000150:complications*; D004361:Drug Tolerance; D010450:Endopeptidases / Q000008:administration & dosage; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D008049:Lipase / Q000008:administration & dosage; D008297:Male; D008863:Microspheres; D020799:Pancrelipase / Q000008:administration & dosage*; D010342:Patient Acceptance of Health Care; D012449:Safety
D002214:Capsules; D005765:Gastrointestinal Agents; D020799:Pancrelipase; D008049:Lipase; D000681:Amylases; D010450:Endopeptidases