Exenatide is Not Associated with Increased Risk of Acute Renal Failure

The objective of the study was to measure adjusted risks of acute renal failure (ARF) in diabetic patients initiating treatment with exenatide, sitagliptin or other control oral agents. In 2009, the U.S. Food and Drug Administration (FDA) added a warning to exenatide’s label about its possible association with a higher risk of developing ARF. This study also evaluated the risk of ARF with sitagliptin because sitagliptin, like exenatide, exerts effects on the incretin system. The study included patients 18 to 63 years of age with continuous prescription benefit coverage through Medco Health Solutions, Inc. between January 1, 2007 and 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.

Cox analysis adjusted for baseline differences in ARF risk factors demonstrated diabetic subjects had a higher risk of ARF (HR 1.7, CI 1.5-1.9, p<0.001) than the non-DM control group. In adjusted analyses, neither exenatide (HR 1.00, CI 0.70- 1.44, p = 0.985) nor sitagliptin (HR 1.19, CI 0.93-1.53, p=0.172) use increased the risk of ARF compared with the DM control group.

Based on the results, this analysis did not find an association between exenatide or sitagliptin and an increased risk of ARF. When assessing the potential risks and benefits of exenatide or sitagliptin for an individual patient, clinicians may want to consider renal failure very rare, unmeasured, potential complication regardless of the treatment therapy.

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

Based on a study by Medco Health Solutions, Inc., in conjunction with the Medco Research Institute™ and the University of Texas Southwestern Medical School. Presented at the American Diabetes Association’s 70th Scientific Sessions in June 2010.

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