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Effects of liraglutide compared with placebo on events of acute gallbladder or biliary disease in patients with type 2 diabetes at high risk for cardiovascular events in the LEADER randomized trial

Diabetes Care Aug 17, 2019

Nauck MA, et al. - Researchers analyzed gallbladder- and biliary tract-related events reported for the liraglutide and placebo groups in The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial. For this investigation, patients with type 2 diabetes at high risk for cardiovascular events (n = 9,340) were randomized 1:1 to receive either liraglutide (≤ 1.8 mg daily; n = 4,668) or placebo (n = 4,672), with both groups also receiving standard care (treatment period: 3.5–5 years). In liraglutide-treated patients, cholecystectomy was conducted more commonly but for comparable ratios of patients experiencing gallbladder- or biliary tract-related events. While LEADER was not specifically designed to evaluate acute gallbladder or biliary disease, the study findings demonstrated an increased risk of gallbladder- or biliary tract–related events with liraglutide compared with placebo, which seemed to be consistent across four categories of these events. The authors noted that appropriate mechanisms should be investigated in further studies.

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