Byetta Found No Worse than Competitors for Acute Pancreatitis

Orlando, FLA recent study presented at an American Diabetes Association (ADA) meeting in Orlando claims that Byetta, a drug used to treat type 2 diabetes, carries no greater risk of acute pancreatitis than other diabetes drugs in its class.

The retrospective study, which included more than 260,000 patients, used data accrued over a period of three years from a large, geographically diverse US healthcare insurance database. About 25,000 patients who were treated with Byetta were compared with 235,000 who were given other meds for their diabetes.

"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 anti-diabetes therapies," said Orville G. Kolterman, MD, senior vice president, chief medical officer, Amylin Pharmaceuticals, in a statement. "The study suggested that cases of pancreatitis in past Byetta users may be related to other risk factors, such as gallstones, past acute pancreatitis and obesity."

Current Byetta users may find this outcome encouraging, but they would do well to recall that the US Food and Drug Administration (FDA) issued a communiqué in November of last year with regard to the potential for kidney problems in patients taking Byetta for type 2 diabetes.

In its 11/2/09 statement, the FDA noted that from April 2005 through October 2008 the agency received 78 reports of kidney problems from a pool of nearly seven million Byetta users. While the FDA noted the incidence rate is small, "health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," said Amy Egan, MD, MPH, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research.

"Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back."

Byetta (exenatide) injection is manufactured by Amylin Pharmaceuticals Inc. and Eli Lilly and Company. The findings of the retrospective study on the potential for Byetta acute pancreatitis, together with other Byetta news, were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando.