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A study released in late June has brought some welcome news to the makers of Byetta and Januvia: Users of the two diabetes drugs run no greater risk of developing pancreatitis than people with diabetes who take other drugs. In fact, both drugs seem to put users at slightly less risk for the condition.
Pancreatitis is an inflammation of the pancreas that can be extremely painful. In rare cases, it can lead to death. The study, conducted by Medco Health Solutions and the University of Texas Southwestern Medical School, found that people with diabetes already run twice the risk for acute pancreatitis as people who do not have diabetes.
Among those studied who were taking other diabetes medications, there were 5.72 cases of acute pancreatitis for every 1,000 patient years. The statistics for the Byetta and Januvia groups were, respectively, 5.69 and 5.54. (A fourth group, the control, took no diabetic medications at all.)
Byetta, the commercial name for exenatide, is co-manufactured by Amylin Pharmaceuticals and Eli Lilly & Co. Januvia, the commercial name for sitagliptin, is manufactured by Merck.
The FDA first raised concerns about Byetta in 2008 when it noted that 30 Byetta users had developed acute pancreatitis and that six of those patients later died. In 2009, the agency ordered a change in prescribing information for Januvia and Janumet in the wake of concerns about 88 users of the drug who has developed pancreatitis. (The FDA included Janumet, a combination of sitagliptin and metformin, because of its concerns that sitagliptin might be a causal factor in the pancreatitis.)
Both manufacturers strongly protested the FDA's methodology. In the case of Byetta, the statistical incidence of 30 cases of acute pancreatitis among 786,000 U.S. users was the equivalent to 1 in every 26,200 users. The six deaths from the condition were equivalent to 1 in every 131,000 users.
The Medco/University of Texas study was designed to create an accurate positioning of the two drugs among the spectrum of diabetes medications when it comes to incidence of pancreatitis. The researchers based their findings on observations derived from other studies. New Jersey-based Medco is a pharmacy benefit manager that runs its own chain of pharmacies and deals directly with about 20 percent of the U.S. population. The company lists Byetta and Januvia in its roster of preferred drugs.
(Editor's note: The author of this article, Patrick Totty, has been taking Byetta for almost two years as part of a clinical trial sponsored by a drug company that wishes to enter the U.S. market with a similar drug.)
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0 comments - Jul 8, 2010