No increased risk of pancreatitis with Byetta; study

USA-based Amylin Pharmaceuticals and Eli Lilly presented interim results from a retrospective study including nearly 260,000 patients that showed  the risk of acute pancreatitis among subjects initiating therapy with  Byetta (exenatide) injection was not increased compared to those  starting other antidiabetic therapies, at the annual meeting of the  American Diabetes Association in New Orleans. Last year, the US Food and  Drug Administration issued a letter warning of the potential for Byetta  (exenatide to cause pancreatitis (Marketletter October 22, 2007) and  sales have stalled for the product since.

The retrospective study used data accrued over three years from a large,  geographically-diverse US health care insurance claims database to  examine the risk of acute pancreatitis in more than 25,000 patients who  were treated with Byetta relative to nearly 235,000 patients who were  given other antidiabetes medications. After propensity score adjustments  were made to reduce bias between the cohorts, use of Byetta was not  associated with an increased rate of acute pancreatitis compared to the  other antidiabetes medications, based on the rate ratio and 95%  confidence interval for current, recent and past use of the drug.

"Based on these retrospective data reflecting Byetta use over a  three-year period, we found no evidence for a higher risk of acute  pancreatitis associated with the use of Byetta compared to other common  antidiabetes therapies," said Orville Kolterman, senior vice president  of R&D at Amylin. "We plan to further validate this interim analysis of  claims data through medical records review," he added.