There is an increased risk for gallbladder- or biliary tract-related events among patients with type 2 diabetes taking liraglutide versus placebo, according to a study published online in Diabetes Care.

Michael A. Nauck, M.D., from St. Josef-Hospital in Bochum, Germany, and colleagues randomly assigned 9,340 patients with type 2 diabetes at high risk for cardiovascular events to receive either liraglutide (≤1.8 mg daily; 4,668 patients) or placebo (4,672 patients). In post-hoc analysis, gallbladder- and biliary tract-related events were assessed.

The researchers observed an increased risk for acute gallbladder or biliary disease with liraglutide versus placebo (hazard ratio, 1.60). Similar findings were seen for each of the four categories of gallbladder- or biliary tract-related events (uncomplicated gallbladder stones, complicated gallbladder stones, cholecystitis with/without gallbladder stones, and biliary obstruction). In liraglutide-treated patients, cholecystectomy was performed more frequently (hazard ratio, 1.56), although proportions were similar for patients who experienced gallbladder- or biliary tract-related events, regardless of randomization (57 percent with liraglutide versus 59 percent with placebo).

"Further studies are required to confirm the increase in gallbladder- or biliary tract-related events and cholecystectomy with liraglutide, and to investigate the relevant mechanisms," the authors write.