Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study
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 initi...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Diabetology & Metabolic Syndrome |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13098-024-01265-4 |
| _version_ | 1797273732996136960 |
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| author | Laure Alexandre-Heymann Fetta Yaker Pierre Bel Lassen Danièle Dubois-Laforgue Etienne Larger |
| author_facet | Laure Alexandre-Heymann Fetta Yaker Pierre Bel Lassen Danièle Dubois-Laforgue Etienne Larger |
| author_sort | Laure Alexandre-Heymann |
| collection | DOAJ |
| description | 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, HbA1c 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). HbA1c 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 |
| first_indexed | 2024-03-07T14:48:30Z |
| format | Article |
| id | doaj.art-463ef6babda94fcfb139a7822151cc56 |
| institution | Directory Open Access Journal |
| issn | 1758-5996 |
| language | English |
| last_indexed | 2024-03-07T14:48:30Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Diabetology & Metabolic Syndrome |
| spelling | doaj.art-463ef6babda94fcfb139a7822151cc562024-03-05T19:49:27ZengBMCDiabetology & Metabolic Syndrome1758-59962024-02-0116111010.1186/s13098-024-01265-4Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control studyLaure Alexandre-Heymann0Fetta Yaker1Pierre Bel Lassen2Danièle Dubois-Laforgue3Etienne Larger4Service de Diabétologie, AP-HP, Hôpital CochinService de Diabétologie, AP-HP, Hôpital CochinSorbonne Université, INSERM, Nutrition and Obesities: Systemic approaches (NutriOmics)Service de Diabétologie, AP-HP, Hôpital CochinService de Diabétologie, AP-HP, Hôpital CochinAbstract 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, HbA1c 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). HbA1c 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-2023-09047https://doi.org/10.1186/s13098-024-01265-4Fecal elastasePancreatic enzyme replacement therapyExocrine pancreatic insufficiencyDiabetes |
| spellingShingle | Laure Alexandre-Heymann Fetta Yaker Pierre Bel Lassen Danièle Dubois-Laforgue Etienne Larger Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study Diabetology & Metabolic Syndrome Fecal elastase Pancreatic enzyme replacement therapy Exocrine pancreatic insufficiency Diabetes |
| title | Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study |
| title_full | Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study |
| title_fullStr | Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study |
| title_full_unstemmed | Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study |
| title_short | Pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus: a real-life, case–control study |
| title_sort | pancreatic enzyme replacement therapy in subjects with exocrine pancreatic insufficiency and diabetes mellitus a real life case control study |
| topic | Fecal elastase Pancreatic enzyme replacement therapy Exocrine pancreatic insufficiency Diabetes |
| url | https://doi.org/10.1186/s13098-024-01265-4 |
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