Diabetes patients who take the newest class of diabetes drugs have double the risk of being hospitalized with acute pancreatitis, researchers from Johns Hopkins University School of Medicine, Baltimore, reported in JAMA Internal Medicine.

The authors explained that the new forms of sugar-control medications prescribed to diabetes patients are called GLP-1 (glucagon-like peptide-1).

Examples of such drugs include sitagliptin (Januvia) and exenatide (Byetta). These medications were found to contribute to the formation of lesions in the pancreas and an increase in the number of ducts within it, adding to the frequency and severity of inflammation.

When LGP-1 therapies were in the animal studies phase, the US FDA (Food and Drug Administration) received reports of pancreatitis as a side effect, therefore, doctors and regulators were aware of the risk.

In 2007, the FDA announced that acute pancreatitis might be linked to diabetes type 2 drug Byetta.

However, this is the first study to accurately measure how close the link to pancreatitis is for humans taking the newest class of diabetes medications. Their study factored in other risk factors which can increase the risk of pancreatitis, such as obesity, heavy alcohol consumption and gallstones.

Study leader Sonal Singh, M.D., M.P.H., assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine, said:

“These agents are used by millions of Americans with diabetes. These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored and some side effects such as acute pancreatitis don’t appear until widespread use after approval.”

The researchers added that diabetes patients should be alert to pancreatitis signs and symptoms, which typically include:

  • Persistent nausea
  • Persistent vomiting
  • Sudden onset of severe and dull pain in the center of the abdomen, around the top of the stomach. If the pancreatitis is caused by gallstone, the pain usually develops after a large meal.
  • There may also be diarrhea, loss of appetite, fever, and less commonly, jaundice (yellowing of the skin and the whites of the eyes)

Acute pancreatitis is a serious, possibly life-threatening condition, where the pancreas suddenly and rapidly becomes inflamed. The pancreas is a small organ, shaped like a tadpole, located behind the stomach, just below the ribcage.

The pancreas has two important functions:

  • It produces digestive juices which help digest food in the gut
  • It produces important hormones, including insulin which allows glucose to enter cells and regulates levels of sugar in the blood

Singh and team gathered and analyzed data from seven BlueCross BlueShield health insurance plans.

Initially, they identified 1,269 patients with type 2 diabetes who were prescribed at least one medication to treat diabetes between 2005 and 2008. They then matched them with 1,269 people also with diabetes type 2 who had not been prescribed any diabetes drugs. They controlled for the other known factors that can cause pancreatitis.

The scientists found that those who took one of the GLP-1 drugs had double the risk of being hospitalized with acute pancreatitis within two months of starting their GLP-1 therapy, compared to those who were on a different type of drug.

In an Abstract in the same journal, the authors wrote:

“In this administrative database study of US adults with type 2 diabetes mellitus, treatment with the GLP-1-based therapies sitagliptin and exenatide was associated with increased odds of hospitalization for acute pancreatitis.”

When we eat, sugar (glucose) enters the bloodstream from the food in our stomach. Glucose is essential for the survival of cells. For glucose to enter the cell, it needs insulin. Without insulin, the glucose remains in the blood without entering the cells, and the cells starve.

Our bodies sense the rise in blood glucose levels after eating and release insulin from the pancreas. As the glucose enters the cells, glucose blood levels drop, which reduces the release of insulin.

A person with diabetes type 2 either does not produce the right amount of insulin or the body does not use the insulin properly (or both). If there is not enough insulin in the bloodstream, or if the insulin is not used properly, glucose does not enter the cells properly either, and builds up in the bloodstream.

People with diabetes are already at a higher risk of developing pancreatitis because of the role of the pancreas in diabetes.

Written by Christian Nordqvist