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.

• Authors: U Halm, C Löser, M Löhr, M Katschinski, J Mössner
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 13 Issue 7 Pg. 951-7 (Jul 1999) ISSN: 0269-2813 [Print] England
• PMID: 10383531 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dietary Fats
• Gastrointestinal Agents
• Pancreatin

Topics

• Adult
• Chemistry, Pharmaceutical
• Chronic Disease
• Cross-Over Studies
• Dietary Fats (metabolism)
• Double-Blind Method
• Exocrine Pancreatic Insufficiency (drug therapy, metabolism)
• Feces
• Female
• Gastrointestinal Agents (administration & dosage)
• Germany
• Humans
• Male
• Microspheres
• Middle Aged
• Pancreatin (administration & dosage)
• Pancreatitis (drug therapy, metabolism)
• Particle Size
• Prospective Studies