A popular group of drugs used to treat type 2 diabetes was shown to have no association with acute pancreatitis but an increased risk of bile duct and gallbladder disease. This was revealed based on the first population-based study investigating the possibility of an association with incretin-based drugs. These drugs are proven to be excessively popular for their effectiveness without causing hypoglycaemia, a problem with other classes of diabetes medications. Furthermore, they are shown to have beneficial effects on body weight.
“Early signal detection studies suggested that an association might exist. The suspicion was credible because these drugs act directly on the pancreas and there was a concern that they could be responsible for inflammation,” said Dr. Laurent Azoulay, Senior Investigator at the Lady Davis Institute at the Jewish General Hospital and Associate Professor in the Department of Epidemiology, at McGill University. “However, ours was the largest study ever to address the question – involving a cohort of more than 1.5 million patients – and there is no evidence to support that either type of incretin-based drug causes acute pancreatitis.”
Although they have been prescribed to millions of patients, the safety of the drug remains controversial. Two studies led by Dr. Azoulay, demonstrated that despite an increased risk of bile duct and gallbladder disease, these drugs are not associated with increasing the risk of acute pancreatitis. Both studies are published in the JAMA Internal Medicine.
“Notwithstanding the latter finding, the totality of the evidence accumulated to date suggests that incretin-based drugs are effective and generally safe,” Dr. Azoulay concludes. “Nonetheless, it’s important that clinicians and patients alike be well informed about possible adverse effects. As a result of the gallbladder finding, it would be prudent for doctors to warn their patients to seek treatment if they experience symptoms, such as pain in their right side.” The most prevalent adverse effect is gallstones which are treatable but can cause extreme pain. In very severe cases the surgical removal of the gallbladder may be required.
The study concluded that nearly 3 more individuals per 1000 will exhibit symptoms as compared with those not taking this medication.
“Clinical trials are the gold standard to assess whether medications are effective, but because of their relative small sample sizes and short durations of follow-up, they are not designed to assess the risk of uncommon but clinically important adverse events,” said Dr. Azoulay, “this is where well designed studies conducted in the real-world setting can provide critical information on the safety of medications.”