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.

Abstract

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.

AIM:

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.

• Authors: J E Domínguez-Muñoz, J Iglesias-García, M Iglesias-Rey, A Figueiras, M Vilariño-Insua
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 21 Issue 8 Pg. 993-1000 (Apr 15 2005) ISSN: 0269-2813 [Print] England
• PMID: 15813835 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Pancreatic Extracts

Topics

• Administration, Oral
• Adult
• Aged
• Cross-Over Studies
• Drug Administration Schedule
• Exocrine Pancreatic Insufficiency (therapy)
• Female
• Humans
• Male
• Middle Aged
• Pancreatic Extracts (administration & dosage)
• Prospective Studies