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LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the
William M Steinberg1, Michael A Nauck, Bernard Zinman
1From the *Department of Medicine, George Washington University Medical Center, Rockville, MD; †Department of Internal Medicine/Diabetology, Diabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz, Germany; ‡Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada; §Thyroid Unit and Department of Medicine, Massachusetts General Hospital Harvard Medical School, Boston, MA; ║Park Nicollet Institute for Research and Education, International Diabetes Center, Minneapolis, MN; ¶Department of Medicine, Friedrich Alexander University of Erlangen, Erlangen, Germany; #Novo Nordisk, A/S, Bagsvaerd, Denmark; **Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern, Dallas, TX; and ††Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.
Objectives:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
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