Research Areas

Acute Pancreatitis is Not Increased in Type 2 Diabetic Patients Treated with Exenatide or Sitagliptin

Authors: Merri Pendergrass, M.D., Ph.D. ¹, ²and William Chen, PhD, MPH ¹

Presented on June 27, 2010 by Dr. Merri Pendergrass at the American Diabetes Association’s 70th Scientific Sessions

Study in Brief:
- This study examined the relationship between exenatide and sitagliptin and incidence of acute pancreatitis (AP). During the last few years, the U.S. Food and Drug Administration added warnings to the labels of these drugs about their possible association with a higher risk of developing AP.

- The study involved more than 786,000 patients, 18 to 63 years of age, for which there was at least 12 months of continuous pharmacy and medical claims information during the study period (January 1, 2007 through June 30, 2009).

- The primary focus of the analysis was diabetic patients (identified by ICD-9 code 250 – diabetic mellitus (DM) designation) who started a new antidiabetic drug between July 1, 2007 and December 31, 2008. They were divided into three groups based on the newly prescribed medication: exenatide, sitagliptin, and a DM control group which included patients newly prescribed sulfonylurea, biguanide or thiazolidinedione. A non-diabetic control group (non-DM) was also identified.

- All patients were observed until one of the following events occurred: the patient experienced AP, the patient discontinued the use of the newly prescribed medication, or the observation period ended.

- There was no significant difference in the incident rate of AP among the exenatide, sitagliptin and DM Control groups. Risk of AP was significantly higher in the combined diabetic groups compared with the non-diabetic control group (adjusted hazard ration (HR) 2.1, 95% confidence interval (CI) 1.7-2.5).

- This study shows that, although rare, acute pancreatitis is a potential complication in type 2 diabetes patients regardless of the treatment therapy. Patients initiating treatment with either exenatide or sitagliptin are no more likely to develop acute pancreatitis than patients initiating treatment with other antidiabetic drugs. The limitations of this observational claims-based analysis cannot exclude the possibility of a relatively small increased risk.

¹Medco Health Solutions, Inc., Franklin Lakes, NJ;² University of Texas Southwestern Medical School, Dallas, TX

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Author Perspectives

Merri Pendergrass, M.D., Ph.D.

National Practice Leader
Medco Health Solutions, Inc.

This study focused on two of the most recent drugs approved for the treatment of type 2 diabetes: exenatide (Byetta^®) and sitagliptin (Januvia^®), both of which affect the incretin system. These drugs are important therapeutic options because they can improve a patient’s blood glucose level while reducing the risk of hypoglycemia and weight gain.

Due to reported cases of acute pancreatitis (AP), the U.S. Food and Drug Administration (FDA) added a warning to the exenatide label in October 2007 and to the sitagliptin label in November 2009. It remains unknown whether exenatide or sitagliptin increase the risk of AP. This issue has not been systematically evaluated in an analysis that controls for medical conditions and medications associated with an increased risk of AP. As the use of incretin-based therapies increases, it is critical that potential adverse effects be fully characterized so clinicians and patients can balance potential benefits and harms of these agents.