A double‐blind, randomized, multicentre, crossover study to prove equivalence of pancreatin minimicrospheres versus microspheres in exocrine pancreatic insufficiency

Abstract

Background : Modern pancreatin preparations consist of enteric‐coated microspheres to protect the enzymes from gastric acid. There are, however, no clinical trials comparing different sizes of pancreatin microspheres with regard to fat excretion and fat intake. Aim : To prove both equivalent efficacy and safety of conventional pancreatin microspheres and smaller pancreatin minimicrospheres in patients with exocrine insufficiency due to chronic pancreatitis. Methods : In this prospective, randomized, double‐blind, multicentre, crossover trial, patients with a stool fat excretion of > 7.5 g/day during a placebo period were randomly assigned either to the minimicrosphere/microsphere treatment sequence or vice versa. The primary end‐point was the coefficient of fat absorption, which was calculated from fat excretion and fat intake during the course of a standardized diet. Stool weight, clinical symptoms and the safety of the preparations were also evaluated. Results : Thirty‐seven patients entered the study, of whom 23 fulfilled the criteria for the crossover period. In the per protocol analysis (n=18), the 90% confidence intervals for the coefficient of fat absorption of both crossover periods lay entirely within the equivalence range (P=0.02). The intention‐to‐treat analysis revealed similar results, but the equivalence range was slightly missed (P=0.07). Similar results were obtained for the secondary parameters and the reported adverse events. Conclusions : Pancreatin minimicrospheres have been shown to be equally effective as microspheres in improving the coefficient of fat absorption in patients with exocrine insufficiency due to chronic pancreatitis.

Partial Pancreatic Resection for Pancreatic Malignancy Is Associated with Sustained Pancreatic Exocrine Failure and Reduced Quality of Life: A Prospective Study

“…Stool was collected on 3 consecutive days (72 h). The patients followed a diet regimen for the 24 h [27] prior to stool fat collection and the 3 days during. The total fat intake per 24 h was 70 or 100 g depending on patient compliance and weight.…”

Delayed release pancrelipase for treatment of pancreatic exocrine insufficiency associated with chronic pancreatitis

“…Marked improvement in fat absorption was observed in a randomized controlled trial using mini-microsphere preparations; 87 however, in a separate double blind multi-center cross-over study, there was no difference between the enteric coated microspheres and mini-microspheres in patients with PEI. 88 Patients, though, preferred the mini-microsphere preparations over the microsphere preparations. Whether the use of these enteric coated mini-microsphere preparations adds any special advantage over the existing therapeutic modalities for the treatment of PEI with CP remains debatable.…”

Emerging Approaches for the Treatment of Fat Malabsorption Due to Exocrine Pancreatic Insufficiency

“…Hence, newer formulations consisting of capsules containing mini-microspheres, pellets or micro-tablets of less than 2 mm in size were designed to promote an adequate intragastric mixture of exogenous enzymes with chyme. Whether the use of these enteric coated mini-microsphere preparations adds any special advantage over the existing treatment options remains, however, subject to great discussion (Halm & al., 1999;Stern & al, 2000).…”