Amylin Pharmaceuticals, Inc and Eli Lilly and Company announced interim results from a retrospective study including nearly 260,000 patients that showed the risk of acute pancreatitis among patients initiating therapy with Byetta (exenatide) injection was not increased compared to patients initiating other anti-diabetic therapies. These findings were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

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 treated with other anti-diabetes 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 anti-diabetes medications, based on the rate ratio (RR) and 95 percent confidence interval (CI) for current (RR 0.9; CI 0.6-1.3), recent (RR 0.9; CI 0.4-2.1) and past (RR 1.4; CI 0.9-2.3) use of Byetta.

"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 anti-diabetes therapies," said Orville G Kolterman, senior vice president of research and development at Amylin. "We plan to further validate this interim analysis of claims data through medical records review."

Amylin and Lilly are working to better understand the relationship between Byetta and pancreatitis described in some spontaneously reported cases. In keeping with the companies' focus on patient safety, Amylin and Lilly continue to pursue a drug safety program that includes thorough investigation of individual spontaneous case reports along with clinical and epidemiologic studies. Within the detection limits of this initial epidemiology study, Amylin and Lilly have not observed an increased incidence of pancreatitis associated with Byetta compared to other treatments for diabetes and thus believe a definite causal relationship between Byetta and pancreatitis has not been proved. Patients and health care professionals should refer to product labelling for guidance regarding the use of Byetta.

Byetta is the first and only FDA-approved incretin mimetic for the treatment of type-2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1).