Effect of the administration schedule on the therapeutic efficacy of oral pancreatic enzyme supplements in patients with exocrine pancreatic insufficiency: a randomized, three-way crossover study.
BACKGROUND
Oral pancreatic enzyme supplements should be properly administered in order to ensure an adequate gastric mixing with the food and simultaneous gastric emptying with the chyme.


OBJECTIVE
To evaluate, in a prospective, randomized, open, comparative, three-way, crossover study, the effect of the administration schedule on the efficacy of oral pancreatic enzymes for the treatment of exocrine pancreatic insufficiency.


METHODS
Twenty-four consecutive chronic pancreatitis patients with maldigestion secondary to exocrine pancreatic insufficiency were treated with 40 000 U lipase in the form of capsules containing enteric-coated mini-microspheres. Capsules were taken just before meals (schedule A), just after meals (schedule B) or distributed along with meals (schedule C) for three consecutive 1-week crossover periods in a randomized order. Fat digestion before and during the three treatment periods was evaluated by an optimized mixed (13)C-triglyceride breath test.


RESULTS
Before therapy, the (13)CO(2) recovery in the breath test was 23.8 +/- 15.8% (normal >58.0%). During therapy, the (13)CO(2) recovery tended to be higher when capsules were taken along with meals ((13)CO(2) recovery 61.4 +/- 21.4%) or just after meals ((13)CO(2) recovery 60.6 +/- 21.8%) than when taken just before meals ((13)CO(2) recovery 53.9 +/- 20.3%). The percentage of patients who normalized fat digestion under therapy was 50, 54 and 63% with schedules A, B and C respectively.


CONCLUSIONS
The efficacy of pancreatic enzyme supplements for the treatment of exocrine pancreatic insufficiency may be optimized by administration during or after meals.
Domínguez-Muñoz
J E
JE
Department of Gastroenterology, University Hospital of Santiago de Compostela, C/Choupana s/n, E-15706 Santiago de Compostela, Spain. enrique.dominguez.munoz@sergas.es
Iglesias-García
J
J
Iglesias-Rey
M
M
Figueiras
A
A
Vilariño-Insua
M
M
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D010188:Exocrine Pancreatic Insufficiency / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010184:Pancreatic Extracts / Q000008:administration & dosage*; D011446:Prospective Studies
D010184:Pancreatic Extracts