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GLP-1 agents led to more frequent pancreatitis hospitalization
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Patients with type 2 diabetes have a significantly increased risk for hospitalization for acute pancreatitis resulting from the use of sitagliptin or exenatide, according to researchers from the Johns Hopkins University School of Medicine. The findings were published in JAMA Internal Medicine.
“These agents are used by millions of Americans with diabetes. These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored, and some side effects such as acute pancreatitis don’t appear until widespread use after approval,” researcher Sonal Singh, MD, MPH, said in a press release.
Singh, an assistant professor in the division of general internal medicine, and colleagues conducted a population-based case-control study using administrative claims data from seven Blue Cross Blue Shield Association plans. Claims included adult patients (n=1,269) with type 2 diabetes who filled at least one prescription for a drug used to treat their condition from February 2005 to December 2008 (aged 18 to 64 years, with a mean age of 52 years). They were matched with controls (n=1,269) to determine whether glucagon-like peptide 1-based therapies such as exenatide and sitagliptin were associated with an increased risk for acute pancreatitis, the researchers wrote.
According to data, patients who were assigned one of the GLP-1 agents were more likely to be hospitalized with pancreatitis compared with those who were assigned another medication. They also were more likely to have hypertriglyceridemia (12.92% vs. 8.35%), alcohol use (3.23% vs. 0.24%), gallstones (9.06% vs. 1.34%), tobacco abuse (16.39% vs. 5.52%), obesity (19.62% vs. 9.77%), biliary and pancreatic cancer (2.84% vs. 0%), cystic fibrosis (0.79% vs. 0%) and any neoplasm (29.94% vs. 18.05%), according to data.
Upon further adjustments for confounders and metformin, patients who were assigned GLP-1–based therapies within 30 days and recently assigned an agent beyond 30 days and less than 2 years were significantly more likely to develop acute pancreatitis vs. patients who did not use GLP-1 agents (adjusted OR=2.24; 95% CI, 1.36-3.68 and AOR=2.01; 95% CI, 1.37-3.18, respectively).
These findings suggest a significantly increased risk for hospitalization for acute pancreatitis resulting from the use of sitagliptin or exenatide among adult patients with type 2 diabetes, the researchers wrote. They recommend long-term prospective studies to examine other outcomes.
AACE, ADA release statement
However, in a joint response to the published JAMA article, the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA) said the study does not provide the basis for changing treatment in patients with diabetes.
“The analysis is a retrospective study using data from an administrative database. This type of analysis is not considered as robust as a prospective randomized controlled clinical trial, the gold standard for evaluating treatments. There are currently nine ongoing, prospective, controlled trials of GLP-1 based therapy with over 65,000 subjects, which should provide answers to these important safety questions,” the groups said in a press release.
The AACE and ADA caution that although there are risks and benefits associated with any therapy, the retrospective analysis by Singh and colleagues indicates GLP-1 based therapies are associated with a relatively small excess risk of hospitalization for acute pancreatitis, with only two additional cases per 100 patients over a 3-year period.
“This same population of adults, between the ages of 18-64 with type 2 diabetes, had a greater risk of hospitalization for acute pancreatitis if they used tobacco, consumed alcohol or were obese,” the groups said in the press release. “As with any therapy, we encourage patients to speak with their doctors to assess which treatments are best for them and to not stop therapy on their own without consulting their doctors.”
Disclosure: The researchers report no relevant financial disclosures.
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