New Class of Type 2 Diabetes Drug Associated with Rare, Life-threatening Outcome

A new class of drugs, known as SGLT2 inhibitors, is increasingly being prescribed for the treatment of Type 2 diabetes, but may increase the risk of a rare but serious complication known as diabetic ketoacidosis.   

In a new study published in The New England Journal of Medicine, investigators from Brigham and Women’s Hospital (BWH) quantified this risk, finding that patients are twice as likely to experience diabetic ketoacidosis if taking an SGLT2 inhibitor rather than another class of drugs for the treatment of diabetes.

“For patients taking an SGLT2 inhibitor, we estimate that only about one in every 1,000 patients will experience diabetic ketoacidosis. Even though this complication is extremely rare, physicians should still be vigilant for symptoms and signs among patients with Type 2 diabetes,” says corresponding author Michael Fralick, MD, FRCPC, of the BWH Division of Pharmacoepidemiology and Pharmacoeconomics.

The BWH research team studied 40,000 patients taking SGLT2 inhibitors, comparing their outcomes to those of patients taking a DPP4 inhibitor. After 180 days, 55 patients taking an SGLT2 inhibitor had experienced diabetic ketoacidosis, while 26 patients taking the other class of drug had experienced this side effect.

“This is a side effect that is usually seen in patients with Type 1 diabetes mellitus – not Type 2 – so doctors are not ‘on the lookout’ for it. This means that the risk of this side effect might be even higher than what we found, due to misdiagnosis or under-recording,” says Dr. Fralick.