Dr. Steinberg’s work shows that serum lipase is increased in about one-fourth of diabetes patients treated with victoza/liraglutide. Lipase elevation occurred at 6 months of treatment and remained so till the end of study.
Importantly, victoza use or the rise in lipase do not anticipate or cause future events of acute pancreatitis. A group of about 9,000 participants were followed for 4 years.
Saxenda/Victoza, lipase and pacreatitis (part 2)
Secondary Analysis (LEADER)
Objective: To evaluate serum amylase and lipase levels and the rate of acute pancreatitis in patients with type 2 diabetes and high cardiovascular risk randomized to liraglutide or placebo and observed for 3.5–5.0 years.
Research Design and Methods: A total of 9,340 patients with type 2 diabetes were randomized to either liraglutide or placebo – median observation time 3.84 years. Fasting serum lipase and amylase were monitored. Acute pancreatitis was adjudicated in a blinded manner.
Results: Compared with the placebo group, liraglutide-treated patients had increases in serum lipase and amylase of 28% and 7%, respectively. Levels were increased at 6 months and then remained stable. During the study, 18 (0.4%) liraglutide-treated and 23 (0.5%) placebo patients had acute pancreatitis confirmed by adjudication.
Most acute pancreatitis cases occurred ≥12 months after randomization. Liraglutide-treated patients with prior history of pancreatitis (n = 147) were not more likely to develop acute pancreatitis than similar patients in the placebo group (n = 120). Elevations of amylase and lipase levels DID NOT PREDICT future risk of acute pancreatitis (positive predictive value <1.0%) in patients treated with liraglutide.
Conclusions: In a population with type 2 diabetes at high cardiovascular risk, there were numerically fewer events of acute pancreatitis among liraglutide-treated patients (regardless of previous history of pancreatitis) compared with the placebo group. Liraglutide was associated with increases in serum lipase and amylase, which were not predictive of an event of subsequent acute pancreatitis