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


OBJECTIVE
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.
Halm
U
U
Department of Internal Medicine II, University of Leipzig, Germany. halmu@medizin.uni-leipzig.de
Löser
C
C
Löhr
M
M
Katschinski
M
M
Mössner
J
J
D000328:Adult; D002626:Chemistry, Pharmaceutical; D002908:Chronic Disease; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000378:metabolism*; D004311:Double-Blind Method; D010188:Exocrine Pancreatic Insufficiency / Q000188:drug therapy* / Q000378:metabolism; D005243:Feces; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D005858:Germany; D006801:Humans; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010194:Pancreatin / Q000008:administration & dosage*; D010195:Pancreatitis / Q000188:drug therapy* / Q000378:metabolism; D010316:Particle Size; D011446:Prospective Studies
D004041:Dietary Fats; D005765:Gastrointestinal Agents; D010194:Pancreatin