Pancreatin therapy in patients with insulin-treated diabetes mellitus and exocrine pancreatic insufficiency according to low fecal elastase 1 concentrations. Results of a prospective multi-centre trial.
BACKGROUND
Recently, high prevalence of exocrine dysfunction in diabetic populations has been reported. Patients with fecal elastase 1 concentration (FEC) <100 microg/g have also been demonstrated to suffer from steatorrhea in about 60% of cases, indicating the need of pancreatic enzyme replacement therapy. Until now, there have only been a few reports on the use of enzyme replacement therapy in diabetic patients with exocrine pancreatic insufficiency. This investigation was designed to evaluate the impact of enzyme-replacement therapy on glucose metabolism and diabetes treatment in a prospective study of insulin-treated patients with diabetes mellitus.


METHODS
A total of 546 patients with diabetes mellitus requiring insulin treatment were screened for exocrine dysfunction by FEC measurements. One hundred and fifteen patients (21.1%) had FEC <100 microg/g (normal >200 microg/g). Of these, 95 patients entered the study and 80 patients were randomized to receive either pancreatin (Creon) (39 patients) or placebo (41 patients) in a double-blind manner. Parameters of glucose metabolism, diabetes therapy and clinical symptoms were recorded in standardized protocols for 16 weeks.


RESULTS
During the observation phase of 16 weeks, there were no significant differences between both groups concerning HbA(1c), fasting glucose levels, 2-h pp glucose levels, clinical parameters and safety parameters. A reduction in mild and moderate hypoglycemia was observed in the pancreatin group at the end of the study.


CONCLUSIONS
Pancreatin therapy can be used safely in patients with diabetes mellitus and exocrine dysfunction. Parameters of glucose metabolism were not improved by enzyme replacement therapy.
Ewald
Nils
N
Third Medical Department and Policlinic, Giessen University Hospital, Giessen, Germany. nils.ewald@innere.med.uni-giessen.de
Bretzel
Reinhard G
RG
Fantus
Ivan G
IG
Hollenhorst
Manfred
M
Kloer
Hans U
HU
Hardt
Philip D
PD
D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology / Q000503:physiopathology; D005243:Feces / Q000201:enzymology; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D010182:Pancreatic Diseases / Q000188:drug therapy* / Q000453:epidemiology; D010196:Pancreatic Elastase / Q000378:metabolism*; D010194:Pancreatin / Q000627:therapeutic use*; D018579:Patient Selection; D010919:Placebos; D015995:Prevalence; D011446:Prospective Studies
D005765:Gastrointestinal Agents; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010196:Pancreatic Elastase; D010194:Pancreatin; D010919:Placebos