학술논문

Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case-control study
Document Type
Report
Source
Diabetology & Metabolic Syndrome. February 9, 2024, Vol. 16 Issue 1
Subject
Biopharmaceutics -- Comparative analysis
Diabetes therapy -- Comparative analysis
Enzymes -- Health aspects -- Comparative analysis
Pancreatitis -- Comparative analysis
Pancreatic insufficiency -- Comparative analysis
Gastrointestinal diseases -- Comparative analysis
Type 2 diabetes -- Comparative analysis
Hyperglycemia -- Comparative analysis
Language
English
ISSN
1758-5996
Abstract
Background Exocrine pancreatic insufficiency (EPI) can be associated with all types of diabetes. Pancreatic enzyme replacement therapy (PERT) has short and long-term benefits in subjects with EPI, but its effects on diabetes control are uncertain. We aimed to study the effects of PERT initiation on glycemic control in subjects with diabetes and EPI from any cause. Methods In this retrospective study, we compared subjects with EPI and diabetes who were prescribed PERT with subjects with diabetes who had a fecal elastase-1 concentration dosage, but did not receive PERT. The primary outcome was the effect of PERT on hypoglycemia frequency and severity. The secondary outcomes were the effects of PERT on gastro-intestinal disorders, HbA.sub.1c and body mass index (BMI). Results 48 subjects were included in each group. Overall, PERT did not have any significant effect on hypoglycemia frequency or severity, but hypoglycemia frequency tended to decrease in subjects with chronic pancreatitis. While 19% of subjects experienced mild hyperglycemia after PERT initiation, we did not report any keto-acidosis or any other severe adverse event. Gastro-intestinal disorders improved in 80% of subjects treated with PERT, versus in 20% of control subjects (p = 0.02). Gastro-intestinal disorders improved in 87% of subjects with recommended dosage of PERT, versus in 50% of subjects with underdosage (NS). HbA.sub.1c and BMI evolution did not differ between the groups. Conclusions PERT initiation is safe in subjects with diabetes and EPI. It does not globally decrease hypoglycemia severity of frequency, but is associated with a decrease in gastro-intestinal disorders. Trial registration Retrospectively registered. The database was registered with the Commission Nationale Informatique et Libertés (CNIL), registration number: 2203351v0. The study was approved by the local ethics committee CLEP, registration number: AAA-2023-09047 Keywords: Fecal elastase, Pancreatic enzyme replacement therapy, Exocrine pancreatic insufficiency, Diabetes
Author(s): Laure Alexandre-Heymann[sup.1,2], Fetta Yaker[sup.1], Pierre Bel Lassen[sup.3,4], Danièle Dubois-Laforgue[sup.1,2] and Etienne Larger[sup.1,2] Background Exocrine pancreatic insufficiency (EPI) is a hallmark of diabetes mellitus secondary to pancreatic diseases, also known [...]