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Exenatide Not Associated with Increased Rate of Acute Pancreatitis Compared to other Antidiabetic Drugs

Posted: Wednesday, June 17, 2009

Retrospective Cohort Study included more than 25,000 BYETTA patients accrued over three years.

Amylin Pharmaceuticals, 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 antidiabetic therapies.

The retrospective study used data accrued over three years from a large, geographically diverse U.S. 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 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 (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 antidiabetes therapies," said Orville G. Kolterman, M.D., 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 labeling for guidance regarding the use of BYETTA.

Eligible patients were enrolled in the health care 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. Propensity scores for BYETTA initiation were developed from baseline characteristics (proxies for diabetes severity, cardiovascular disease, known acute pancreatitis risk factors and empirically derived variables), which were obtained from nine months of claims data prior to cohort entry. Cases of acute pancreatitis were defined by a primary diagnosis of acute pancreatitis associated with an emergency room visit or hospitalization during follow-up.  Initiators of BYETTA (n=25,719; 80 percent age 40-64 years old) were more likely to be female (56 vs. 49 percent) and had a higher baseline prevalence of claims for Type 2 diabetes (84 vs. 59 percent), obesity (16 vs. 8 percent) and cardiovascular risk factors (hyperlipidemia 77 vs. 54 percent; hypertension 64 vs. 49 percent) than initiators of other antidiabetes medications. In addition, BYETTA initiators were more likely to use multiple antidiabetes medications. These results are undergoing further validation by medical records review.

Source: Diabetes In Control: Presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

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