Original ResearchClinical—PancreasPancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies
Section snippets
Study Design
The primary goal of this analysis was to use the FDA AERS database to assess the association between treatment with exenatide (Byetta) or sitagliptin (Januvia) and an adverse event report of pancreatitis, where the drugs were listed as the primary suspect associated with a pancreatitis report in the database. A secondary goal was to examine the FDA AERS database for reported pancreatic or thyroid cancer associated with use of exenatide or sitagliptin. Third, we used the FDA AERS database to
Control Events
The validity of the analysis is predicated on a similar rate of reported control events for each drug in the analysis. For the 2 test drugs and 4 control drugs, this was found to be the case. However, one drug initially chosen for the analysis (pioglitazone) had an elevated control event reporting rate compared to the other drugs, which were otherwise similar in their control event rate. This was not driven by any one of the controls, but rather was an overall elevation in reported control
Discussion
We report a >6-fold increased reported adverse event rate for pancreatitis with either of the first two GLP-1−based drugs available on the market in the United States, exenatide and sitagliptin, in this analysis of the FDA AERS database.
Analysis of the FDA AERS database is not the ideal mechanism to compare adverse event rates between drugs. Limitations of the FDA AERS database, including incomplete data and reporting biases, are well-known.29 However, AERS has proven effective in similar
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Conflicts of Interest The authors disclose no conflicts.
Funding Supported by the Larry L. Hillblom Foundation.