The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis.
OBJECTIVE
Creon 10 Minimicrospheres is an enteric-coated, delayed-release pancrelipase preparation designed to deliver active pancreatic enzymes to the small intestine. The primary objective of this study was to compare the effect of Creon 10 with placebo in the control of steatorrhea in chronic pancreatitis patients. Secondary objectives included evaluation of stool parameters and global improvement of symptoms scales.


METHODS
The study was a randomized, double-blind, placebo-controlled, 2-week trial. After a placebo run-in ("washout") phase, the effect on coefficient of fat absorption (%), daily fat excretion before and after treatment, and stool frequency and consistency were assessed.


RESULTS
In Creon 10-treated subjects, the change in mean coefficient of fat absorption (%) from run-in to double-blind phase was significantly higher compared with placebo-treated subjects (+36.7 vs. +12.1, P = 0.0185). Stool consistency improved significantly more with Creon 10 than with placebo (P = 0.0102) resulting in more subjects with formed stool; stool frequency decreased significantly more with Creon 10 than with placebo (P = 0.0015) from 10.8 during placebo run-in to 5.2 stools per day during double-blind treatment; and daily mean fat excretion in stool decreased significantly more (-56.5 vs. -11.4 g/d, P = 0.0181) in Creon 10-treated subjects compared with placebo-treated subjects. Global disease symptom scores showed greater improvement for both physicians and subjects in the Creon 10 group relative to those receiving placebo. Between treatment difference reached statistical significance for Creon 10 (P = 0.0435) for physician score and showed a trend (P = 0.0634) favoring Creon for subject score.


CONCLUSIONS
This randomized, placebo-controlled trial found that Creon 10 treatment controlled steatorrhea, as reflected in reduced fat excretion, decreased stool frequency and improved stool consistency. Creon 10 treatment was safe and well tolerated.
Safdi
Michael
M
Greater Cincinnati Gastroenterology Associates, Cincinnati, OH 45219, USA. msafdi@cincygastro.com
Bekal
Pradeep K
PK
Martin
Stephen
S
Saeed
Zahid A
ZA
Burton
Frank
F
Toskes
Phillip P
PP
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002214:Capsules; D003692:Delayed-Action Preparations; D004041:Dietary Fats / Q000008:administration & dosage / Q000378:metabolism; D005243:Feces / Q000737:chemistry; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D008055:Lipids / Q000032:analysis; D008297:Male; D008875:Middle Aged; D050500:Pancreatitis, Chronic / Q000150:complications / Q000188:drug therapy*; D020799:Pancrelipase / Q000008:administration & dosage / Q000627:therapeutic use*; D017060:Patient Satisfaction; D010919:Placebos; D045602:Steatorrhea / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D002214:Capsules; D003692:Delayed-Action Preparations; D004041:Dietary Fats; D005765:Gastrointestinal Agents; D008055:Lipids; D010919:Placebos; D020799:Pancrelipase