exenatide
Introduction
EXENATIDE WAS INTRODUCED into the U.S. market in 2005 to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control on metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea.1 However, postmarketing reports of acute pancreatitis, including severe forms such as hemorrhagic or necrotizing pancreatitis, developing in patients taking exenatide were submitted to the Food and Drug Administration (FDA)1,2 and have been published in the literature.3,4 Although these reports do not prove a causal link between exenatide and pancreatitis, the FDA added a warning on the exenatide label in 2007 that was strengthened over the next 2 years to note that the postmarketing reports included episodes of both fatal and nonfatal pancreatitis.1,2
The true incidence of exenatide-associated pancreatitis has been difficult to determine, and it is unknown whether exenatide causes pancreatitis. Pancreatitis occurs more frequently in individuals with diabetes,5 and people with type 2 diabetes often have multiple risk factors for pancreatitis.6 Analyses of large claims and pharmacy databases have shown no apparent increased risk for pancreatitis in patients taking exenatide,7–9 while a concern over the possibility of an increased risk of pancreatic cancer from exenatide use has been raised in the FDA adverse event reporting system (AERS) database.10 However, this analysis has been criticized regarding the limitations of using the AERS database for determining event rates.11
In order to better characterize the relationship between exenatide, acute pancreatitis and pancreatic cancer, we analyzed a large commercial claims database of adult U.S residents with private insurance from 2007 through 2009.
Go to:
Research Design and Methods
The RAND Human Subjects Protection Committee ruled that this research was exempt from institutional review board approval.
Data
A retrospective analysis of a large,
EXENATIDE WAS INTRODUCED into the U.S. market in 2005 to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control on metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea.1 However, postmarketing reports of acute pancreatitis, including severe forms such as hemorrhagic or necrotizing pancreatitis, developing in patients taking exenatide were submitted to the Food and Drug Administration (FDA)1,2 and have been published in the literature.3,4 Although these reports do not prove a causal link between exenatide and pancreatitis, the FDA added a warning on the exenatide label in 2007 that was strengthened over the next 2 years to note that the postmarketing reports included episodes of both fatal and nonfatal pancreatitis.1,2
The true incidence of exenatide-associated pancreatitis has been difficult to determine, and it is unknown whether exenatide causes pancreatitis. Pancreatitis occurs more frequently in individuals with diabetes,5 and people with type 2 diabetes often have multiple risk factors for pancreatitis.6 Analyses of large claims and pharmacy databases have shown no apparent increased risk for pancreatitis in patients taking exenatide,7–9 while a concern over the possibility of an increased risk of pancreatic cancer from exenatide use has been raised in the FDA adverse event reporting system (AERS) database.10 However, this analysis has been criticized regarding the limitations of using the AERS database for determining event rates.11
In order to better characterize the relationship between exenatide, acute pancreatitis and pancreatic cancer, we analyzed a large commercial claims database of adult U.S residents with private insurance from 2007 through 2009.
Go to:
Research Design and Methods
The RAND Human Subjects Protection Committee ruled that this research was exempt from institutional review board approval.
Data
A retrospective analysis of a large,