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New Study Reports Increased Risk of Pancreatitis with Onglyza

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A new study links type 2 diabetes drug Onglyza (saxagliptin), an incretin mimetic that stimulates the pancreas to make more insulin after a patient eats a meal, to a small but significant increase for acute pancreatitis.

The results of the study, lead by Rury R. Holman, M.D., director of the University of Oxford Diabetes Trials Unit, United Kingdom, were presented last December at the World Diabetes Congress 2015.

Onglyza Linked with Pancreatitis in Various Studies and Warnings

Researchers examined data from three recent studies on incretin mimetics, or “DPP-4 inhibitors” and cardiovascular outcomes. In each of the three trials, the number of patients with acute pancreatitis (inflammation of the pancreas) was higher with the drug than with the placebo. When the study data was combined, researchers found a significant risk of acute pancreatitis with incretin mimetics.

This isn’t the first time these drugs have been linked with pancreas problems. A 2013 study, for example, found that type 2 diabetes patients treated with DPP-4 inhibitors were at an increased risk for an enlarged pancreas, and even at risk for precancerous changes in the pancreas. The researchers noted that precancerous tumors often have to be removed, surgically, and that taking drugs like Onglyza could lead to an increased risk for pancreatic surgery.

Back in 2009, the FDA issued a safety communication warning healthcare professionals and patients that prescription information for Januvia (sitagliptin)—a similar drug—and Janumet (sitagliptin/metformin) was being revised. The new warnings include information on reported cases of acute pancreatitis in patients using the drugs. The FDA said they had received 88 post-marketing cases of acute pancreatitis in patients using these drugs between October 2006 and February 2009.

The FDA also warned that the use of these drugs in patients with a history of pancreatitis had not been studied, and that doctors should consider the risks before prescribing the medications. They added that signs and symptoms of pancreatitis include nausea and vomiting, anorexia, and severe abdominal pain.

Incretin Mimetics Linked with Pancreatic Problems

In 2013, the British Medical Journal (BMJ) published an article by investigations editor Deborah Cohen, reporting that a BMJ investigation found “growing safety concerns” linked to incretin memetics. Though these drugs were named the “darlings of diabetes treatment,” Ms. Cohen wrote, manufacturers downplayed the risks of pancreatitis and pancreatic cancer. She added that the investigation revealed pharmaceutical companies did not perform critical safety studies.

A later investigation by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), however, suggested there was likely no increased risk of pancreatic cancer associated with these drugs. However, members of an expert panel involved in that investigation noted that longer-term data was needed.

Researchers involved in the latest study reported at the World Diabetes Congress 2015 emphasize that the overall risk for pancreatitis is small, but that patients with previous risk factors for the condition could be at higher risk, and should be particularly cautious. Other risk factors include a history of gallstones, biliary diseases, high triglyceride levels, and high alcohol consumption.

“It’s a small risk,” Dr. Holman told Medscape, “but it’s detectable. It’s not a massive risk. I think for practicing physicians and patients, it helps them make a sound judgment.”

Onglyza has also been linked with an increased risk of hospitalization for heart failure.