JAMA Study: Januvia, Byetta Double Risks for Pancreatitis

jama-study-Januvia-Byetta-Double-RisksPrior research revealed that Januvia (sitagliptin) and Byetta (exenatide), prescribed for the treatment of Type 2 diabetes, have been associated with reports of increased risks for pancreatic and thyroid cancers. Now, a new study finds that the drugs may double patients’ risks for developing pancreatitis.

Although linked to pancreatitis in prior research, the new study, published by JAMA Internal Medicine, was able to provide numbers for that increased risk, said FiercePharma. Januvia and Byetta are sold through a Merck and Bristol-Myers Squibb/AstraZeneca collaboration. Pancreatitis is an inflammation of the pancreas that is linked to cancer and kidney failure, Bloomberg.com explained.

Study author, Sonal Singh, assistant professor at Johns Hopkins University, and colleagues, reviewed insurance records and found that patients hospitalized with pancreatitis experienced a two-fold risk of being diagnosed with the disease if they had taken Januvia or Byetta, when compared to diabetics who did not have pancreatitis, said FiercePharma. The study looked at 1,268 diabetics hospitalized with pancreatitis and 1,268 patients diagnosed with pancreatitis, but who did not have diabetes, explained Bloomberg.com. Of the pancreatitis patients, 87 had filled a prescription for Byetta or Januvia; in the control group, 58 control filled similar prescriptions. “This is the first real study to give an estimate of what the risk is,” said Singh. “[U]ntil now we just had a few case reports,” he added.

Approved in 2006 by the U.S. Food & Drug Administration (FDA), Januvia continues to be associated with risks for pancreatic side effects, pancreatitis, and pancreatic cancer. In 2009, the agency required a label update warning of the risk of acute pancreatitis based on 88 reports of acute pancreatitis in patients who took Januvia between October 2006 and February 2009. Chronic pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer. Byetta, administered via a twice-daily injection, was first approved in 2005 to be used in conjunction with other diabetes treatments and was later approved as a stand-alone therapy for Type 2 diabetes.

Testing for the safety of Januvia has not looked at other effects drugs in the DPP-4 inhibitors class, specifically, the drugs’ role in inhibiting one of the body’s natural cancer-suppressing mechanisms. For example, diabetes patients could be at risk for years before the full effects and risks of taking Januvia and other DPP-4 drugs are known. Amylin Pharmaceuticals came under fire for allegedly hiding a study that revealed serious heart risks associated with Byetta. FDA claimed Amylin concealed the Byetta heart study from the agency, and then tried to keep the FDA from getting its hands on the key data when the agency learned of its existence.

As we’ve explained, both drugs are glucagon-like peptide-1 (GLP-1) based therapies that are in the class dipeptidyl peptidase-4 (DPP-4) inhibitors. The drugs increase certain natural substances that lower raised blood sugar levels. Diabetics typically have abnormally low amount insulin levels or their bodies have difficulties utilizing insulin efficiently. “These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit,” said Singh.

Pancreatitis occurs in about three in every 1,000 diabetes patients. Should that risk double in patients taking Byetta or Januvia, the number would rise to six in every 1,000 patients, said Singh. In the United States, about 8.6 percent of the population—25 million people—were diagnosed with diabetes in 2010, based on Bloomberg.com data. That number is expected to rise to more than 34 million by 2020.

We recently wrote that researchers at the University of California, Los Angeles looked at both Januvia and Byetta in comparison to other therapies and all of the drugs’ risks for pancreatic and thyroid cancers and pancreatitis. The study, published in the journal, Gastroenterology, was conducted by researchers at the University of California and revealed that Januvia and Byetta patients experienced a nearly three-fold risk of developing pancreatic cancer. Evidence also suggests an increased incidence of thyroid cancer among patients taking Byetta.

Other serious side effects have been linked to these Type 2 diabetes drugs including, low blood sugar; anaphylaxis and other allergic reactions including hives, rash, swelling of face, lips, tongue, and/or throat; acute pancreatitis, and death.

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