Yesterday Medco Health Solutions presented a study at the Scientific Sessions of the American Diabetes Association. The study found that, contrary to warnings from the Food and Drug Administration, neither Byetta or Januvia increase the risk of acute pancreatitis.
Byetta and Januvia are two of the most important medications for type 2 diabetes, since they reduce blood glucose without increasing weight, which all the other diabetes drugs (except metformin, Victoza, and Symlin) do. In fact, Byetta is proven to reduce
weight, and that's why I wrote a book about it, Losing Weight with Your Diabetes Medication.
Due to reported cases of acute pancreatitis, several years ago the FDA added warnings to the labels for Byetta and Januvia.
However, Medco's study indicates that patients taking either of these medications were no more likely to develop acute pancreatitis than patients taking other drugs to control diabetes. The study indicates there is an increased risk of acute pancreatitis for people with diabetes. But that it is not associated
with the particular diabetic medication the patients are using.
"While cases of acute pancreatitis have been reported in patients using Byetta and Januvia, diabetic patients who are not taking these drugs also have been reported to have an increased risk for pancreatitis," says Merri Pendergrass, MD, PhD, national practice leader of the Medco Therapeutic Resource Center for Diabetes, who conducted the study. "The major question has been are these medications causing the pancreatitis or are they innocent bystanders? Our findings are reassuring in that they did not reveal any increased risk of acute pancreatitis with Byetta and Januvia."
Medco released even more good news for people taking Byetta. Another one of its studies presented at the ADA's Scientific Sessions found that, despite FDA warnings, Byetta is not associated with an increased risk of acute renal failure in people with type 2 diabetes. This Medco analysis indicated that while there is an increased risk of acute renal failure in people with diabetes, the diabetes drug they are taking does not appear to impact that risk.
Medco Health Solutions Inc. conducted the study in association with the Medco Research Institute and the University of Texas Southwestern Medical School. Medco Health Solutions is a major pharmacy, ranking 35th on the Fortune 500. The study analyzed Medco's pharmacy and medical claims data for more than 786,000 adult patients between January 2007 and June 2009.
They divided the people with diabetes into three groups based on whether they were taking Byetta, Januvia, or other diabetes drugs. A group of people without diabetes served as the control.
While the risk for acute pancreatitis was essentially the same among the three groups of people with diabetes, the average risk for all the diabetes groups was higher than that for the control group. Medco used comparable methodology and study parameters in the two studies.
The lack of increased risk of renal failure was news to me. But I've known for years that Byetta doesn't pose an additional risk of pancreatitis, and I wrote about it here
in October 2007. Now it's time for the FDA to catch up.