February 26, 2013 — The anti-diabetes drugs Januvia (sitagliptin), Byetta (exenatide), and Janumet (sitagliptin / metformin) have been linked to a doubled risk of acute pancreatitis (sudden inflammation in the pancreas). These drugs are in a new class of medications that lower blood-sugar levels by mimicking a hormone called glucagon-like peptide-1 (GLP-1), which stimulates the pancreas to produce more insulin. Unfortunately, this may increase the risk of pancreatic diseases and potentially cancer in some patients.
The study was published in JAMA Internal Medicine and conducted by researchers from Johns Hopkins University in Baltimore. They analyzed data on insurance records form 2005 until 2008, looking for cases of pancreatitis in people with diabetes. They compared data on nearly 1,300 diabetics who developed pancreatitis to the same number of diabetics who did not develop pancreatitis.
Of the group who developed pancreatitis, 87 filled a prescription for Januvia or Byetta, compared to 58 people in the group who did not develop pancreatitis. After adjusting for variables known to increase the risk of pancreatitis, the researchers concluded that pancreatitis was twice as likely to occur in diabetics who used Januvia or Byetta.
Numerically, the risk of Januvia pancreatitis or Byetta pancreatitis is still small. Diabetics already have a higher risk of pancreatitis than the general population, with about 3 cases per 1,000 diabetics every year. If this number is doubled, an estimated 6 people per 1,000 who use Januvia or Byetta will develop pancreatitis.
This is one of the first major studies to take case reports and estimate the actual risk faced by people who use Januvia or Byetta. However, it is not the first time experts have raised concerns about pancreatitis and GLP-1 therapy. The U.S. Food and Drug Administration (FDA) has received hundreds of case reports linking Januvia and Byetta to pancreatitis. They published a warning for Byetta pancreatitis in 2007, and another warning for Januvia pancreatitis in 2009.
Furthermore, pancreatitis is a known risk-factor for pancreatic cancer. Unfortunately, it is unknown if Januvia or Byetta are associated with pancreatic cancer because the cancers are very rare, the drugs are relatively new, and long-term studies have not been conducted. Studies of of GLP-1 medications in rodents have also raised concerns about higher rates of thyroid cancer.
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