LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial

• Published in: Pancreas Vol. 43; no. 8; p. 1223
• Main Authors: Steinberg, William M, Nauck, Michael A, Zinman, Bernard, Daniels, Gilbert H, Bergenstal, Richard M, Mann, Johannes F E, Steen Ravn, Lasse, Moses, Alan C, Stockner, Mette, Baeres, Florian M M, Marso, Steven P, Buse, John B
• Format: Journal Article
• Language: English
• Published: United States 01.11.2014
• Subjects: Acute Disease; Aged; Amylases - blood; Biomarkers; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - enzymology; Double-Blind Method; Fasting - blood; Female; Glucagon-Like Peptide 1 - adverse effects; Glucagon-Like Peptide 1 - analogs & derivatives; Glucagon-Like Peptide 1 - pharmacology; Glucagon-Like Peptide 1 - therapeutic use; Humans; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - pharmacology; Hypoglycemic Agents - therapeutic use; Kidney - physiopathology; Lipase - blood; Liraglutide; Male; Middle Aged; Pancreatitis - chemically induced; Pancreatitis - etiology; Pancreatitis - prevention & control
• ISSN: 1536-4828
• DOI: 10.1097/MPA.0000000000000229

This report from the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial describes baseline lipase and amylase activity in type 2 diabetic subjects without acute pancreatitis symptoms before randomization to the glucagonlike peptide analog liraglutide or placebo. The LEADER is an international randomized placebo-controlled trial evaluating the cardiovascular safety of liraglutide in 9340 type 2 diabetic patients at high cardiovascular risk. Fasting lipase and amylase activity was assessed at baseline, before receiving liraglutide or placebo, using a commercial assay (Roche) with upper limit of normal values of 63 U/L for lipase and 100 U/L for amylase. Either or both enzymes were above the upper limit of normal in 22.7% of subjects; 16.6% (n = 1540) had an elevated lipase level (including 1.2% >3-fold elevated), and 11.8% (n = 1094) had an elevated amylase level (including 0.2% >3-fold elevated). In multivariable regression models, severely reduced kidney function was associated with the largest effect on increasing activity of both. However, even among subjects with normal kidney function, 12.2% and 7.7% had elevated lipase and amylase levels. In this large study of type 2 diabetic patients, nearly 25% had elevated lipase or amylase levels without symptoms of acute pancreatitis. The clinician must take these data into account when evaluating abdominal symptoms in type 2 diabetic patients.