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

Summary Background : Oral pancreatic enzyme supplements should be properly administered in order to ensure an adequate gastric mixing with the food and simultameous 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 13C‐triglyceride breath test. Results : Before therapy, the 13CO2 recovery in the breath test was 23.8 ± 15.8% (normal >58.0%). During therapy, the 13CO2 recovery tended to be higher when capsules were taken along with meals (13CO2 recovery 61.4 ± 21.4%) or just after meals (13CO2 recovery 60.6 ± 21.8%) than when taken just before meals (13CO2 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.