Drug & Device Development

No pancreatitis risk with Januvia (sitagliptin) or Byetta (exenatide)

NEW YORK (Reuters) - Two widely used diabetes medicines, Januvia (sitagliptin) and Byetta (exenatide), pose no additional risk for pancreatitis compared with other diabetes drugs, according to an analysis of medical claims data released on Sunday.

The study also found that diabetics generally are at increased risk of acute pancreatitis, compared with non-diabetics, which the study's author said confirmed previous research, although the risk remains very low.

The analysis was conducted by pharmacy benefit manager Medco Health Solutions, in association with the University of Texas Southwestern Medical School.

Dr. Merri Pendergrass, who conducted the study, acknowledged that it was an observational study of data, as opposed to the gold standard of a randomized clinical trial. But the results were reassuring about use of Byetta and Januvia, said Dr. Pendergrass, national practice leader of Medco's therapeutic resource center for diabetes.

"There does not seem to be a signal of increased risk," she said from Orlando, Florida, where the study was presented at the American Diabetes Association scientific sessions in Orlando. "There's no smoke here, so that's reassuring."

The study analyzed Medco's pharmacy and medical claims data for more than 786,000 adult patients between January 2007 and June 2009.

The diabetic patients were divided into three groups based on the antidiabetic drug they had recently begun taking - Byetta, Januvia or other oral diabetic treatments - as well as a control group of non-diabetics.

For the group taking various diabetic medicines, there were 5.72 cases of acute pancreatitis for every 1,000 patient years. It was 5.69 for Byetta, and 5.54 for Januvia.

After adjusting for other risk factors, diabetics were found to be twice as much at risk for acute pancreatitis as non-diabetics, Dr. Pendergrass said.

"I think this is an important finding," Dr. Pendergrass said. "It wasn't completely unexpected."

Overall, Dr. Pendergrass characterized acute pancreatitis as rare for both diabetics and non-diabetics.

Medco, one the largest U.S. pharmacy benefit managers, has created therapeutic resource centers that focus on various chronic diseases such as diabetes.

Byetta and Januvia are covered brand-name drugs on Medco's standard formulary.

Medco does not disclose specific contracts with drug manufacturers. However, Dr. Pendergrass said Medco has no incentive, financial or otherwise, to see increased use of Byetta or Januvia.

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