Chart Review Consistent with Earlier Related Claims Data Analysis of More Than 25,000 BYETTA Patients Accrued Over Three Years

ORLANDO, Fla., June 26, 2010.  Announced final results from a retrospective study including more than 260,000 patients that showed the risk of acute pancreatitis among initiators of BYETTA(R) (exenatide) injection was not increased compared to initiators of other antidiabetic therapies. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

The retrospective study used data accrued over three years from a large, geographically diverse U.S. healthcare 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 antidiabetes medications. Medical records from claims-identified cases of acute pancreatitis were reviewed by four gastroenterologists, blinded to drug exposure, using a standard assessment tool. In a nested case-control study (NCCS) based on the review, use of BYETTA was not associated with an increased rate of acute pancreatitis compared to the other antidiabetes medications, based on the adjusted odds ratio and 95 percent confidence interval (CI) for current (0.2; CI 0.0-1.4), recent (0.1; CI 0.0-1.3) and past (1.1; CI 0.1-12.3) use of BYETTA.

"This medical records review is consistent with a related earlier analysis of claims data, which showed no evidence for a higher risk of acute pancreatitis associated with the use of BYETTA compared to other common antidiabetes therapies,"(i) said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "The study suggested that cases of pancreatitis in past BYETTA users may be related to other risk factors, such as gall stones, past acute pancreatitis and obesity."

Amylin and Lilly are continuing work 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. Patients and healthcare professionals should refer to product labeling for guidance regarding the use of BYETTA.

Study Design and Findings

Eligible patients were enrolled in the healthcare plan for at least a continuous nine-month baseline period with no history of chronic or acute pancreatitis prior to initiation of a new antidiabetic therapy. Adjudication of 652 claims-identified acute pancreatitis cases resulted in 40 confirmed acute pancreatitis cases in the BYETTA initiators and 254 confirmed cases in the other antidiabetic drug initiators. The NCCS analysis incorporated covariates (claims- and chart-derived) temporally related to acute pancreatitis occurrence to account for differences in the prevalence of risk factors between patients who persisted on or discontinued the study drugs.

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