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The Plain Truth
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Saturday, June 27, 2009

Research Disputes FDA Claim that BYETTA Increase Risk of Acute Pancreatitis

In 2008, the U.S. Food and Drug Administration published strong warnings that the type 2 diabetes drug exenatide (trade name Byetta) might increase risk of acute pancreatitis, a painful inflammation of the pancreas. The FDA's action came in the wake of reports that 30 exenatide users had come down with pancreatitis and that six of them had died from the condition.

Now, however, a study published by researchers from Medco Health Solutions, Inc., says that exenatide users run no greater risk of developing pancreatitis than type 2s who take neither drug.

The study results, presented at the recent 69th Scientific Sessions of the American Diabetes Association (ADA), showed that only 0.44 percent of exenatide users experienced an episode of acute pancreatitis. Among sitagliptin users, only 0.28 percent had such episodes. Among the control group of type 2s, however, who had never taken either drug, the rate of incidence was 0.39 percent.

The study results were based on tracking the pharmacy and medical claims of 123,621 non-insulin-using type 2s for 540 days and observing which ones came down with pancreatitis:

  • 9,260 patients were exenatide users
  • 2,143 patients were on sitagliptin
  • 112,218 patients, the control group, used neither drug but were taking a medication designed to control blood glucose
  • No patient in the study had a history of pancreatitis, hepatitis or alcohol abuse
  • The patients' ages ranged from 18 to 63 years

The Medco study is the first to lend scientific support to Eli Lilly and Co., Byetta's maker. Lilly has questioned the FDA's statistical reasoning, citing the extremely low percentage of pancreatitis cases associated with the drug.

For more information on the study, visit Medco

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