medwireNews: Taking the glucagon-like peptide (GLP)-1 receptor agonist liraglutide does not increase patients’ risk for acute pancreatitis during more than 3 years of treatment, show two reports analyzing the LEADER and SCALE trials.
This was despite liraglutide-treated patients in LEADER having average increases in amylase and lipase levels of 7% and 28%, respectively, versus placebo-treated patients, while those in the SCALE trials had corresponding increases of 7% and 31%. In LEADER, which had a median follow-up of 3.84 years, levels of these enzymes were increased at 6 months, but remained stable thereafter.
In the SCALE trials, enzyme elevations of at least one times the upper limit of normal (ULN) were common and more frequent in liraglutide- than placebo-treated patients, with such elevations of lipase occurring in 43.5% versus 15.1%.
By contrast, elevations of three times the ULN were rare, at 2.9% versus 1.5%, and were not predictive of acute pancreatitis, report William Steinberg (George Washington University Medical Center, Washington, DC, USA) and co-researchers in Diabetes Care, where both studies are published.
The LEADER trial included 9340 patients with type 2 diabetes. The four SCALE trials included a total of 5358 patients; diabetes patients were excluded from three but specifically recruited to the fourth.
Acute pancreatitis events were adjudicated by independent experts who were blinded to treatment allocation. In SCALE, such events occurred in 0.3% of patients who were taking liraglutide 3.0 mg at the time, 0.1% of those who had ceased taking it 35–392 days previously, 0.0% of patients taking liraglutide 1.8 mg, and 0.1% of those taking placebo.
And in LEADER, acute pancreatitis occurred in 0.4% of patients taking liraglutide 1.8 mg and 0.5% of the placebo group.
In both studies, most pancreatitis events were mild and occurred many months after initiation of treatment, and a large proportion were explained by the presence of gallstones. Even LEADER participants with a history of acute pancreatitis had relatively low rates, at 1.4% in the liraglutide group and 5.0% in the placebo group.
“Our results do not support the exclusion of patients with previous pancreatitis from treatment with GLP-1 receptor agonists in general terms and with liraglutide in particular,” conclude the LEADER researchers.
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