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.