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

William M. Steinberg, Michael A. Nauck, Bernard Zinman, Gilbert H. Daniels, Richard M. Bergenstal, Johannes F E Mann, Lasse Steen Ravn, Alan C. Moses, Mette Stockner, Florian M M Baeres, Steven P. Marso, John B. Buse

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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) hadan 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.

Original languageEnglish (US)
Pages (from-to)1223-1231
Number of pages9
JournalPancreas
Volume43
Issue number8
StatePublished - Nov 10 2014

Fingerprint

Amylases
Lipase
Type 2 Diabetes Mellitus
Placebos
Pancreatitis
Kidney
Random Allocation
Liraglutide
Fasting
Reference Values
Randomized Controlled Trials
Safety
Peptides
Enzymes

Keywords

  • Amylase
  • Lipase
  • Pancreatitis
  • Type 2 diabetes

ASJC Scopus subject areas

  • Hepatology
  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Steinberg, W. M., Nauck, M. A., Zinman, B., Daniels, G. H., Bergenstal, R. M., Mann, J. F. E., ... Buse, J. B. (2014). LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial. Pancreas, 43(8), 1223-1231.

LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial. / Steinberg, William M.; Nauck, Michael A.; Zinman, Bernard; Daniels, Gilbert H.; Bergenstal, Richard M.; Mann, Johannes F E; Ravn, Lasse Steen; Moses, Alan C.; Stockner, Mette; Baeres, Florian M M; Marso, Steven P.; Buse, John B.

In: Pancreas, Vol. 43, No. 8, 10.11.2014, p. 1223-1231.

Research output: Contribution to journalArticle

Steinberg, WM, Nauck, MA, Zinman, B, Daniels, GH, Bergenstal, RM, Mann, JFE, Ravn, LS, Moses, AC, Stockner, M, Baeres, FMM, Marso, SP & Buse, JB 2014, 'LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial', Pancreas, vol. 43, no. 8, pp. 1223-1231.
Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JFE et al. LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial. Pancreas. 2014 Nov 10;43(8):1223-1231.
Steinberg, William M. ; Nauck, Michael A. ; Zinman, Bernard ; Daniels, Gilbert H. ; Bergenstal, Richard M. ; Mann, Johannes F E ; Ravn, Lasse Steen ; Moses, Alan C. ; Stockner, Mette ; Baeres, Florian M M ; Marso, Steven P. ; Buse, John B. / LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial. In: Pancreas. 2014 ; Vol. 43, No. 8. pp. 1223-1231.
@article{177280efa70a4201b513df443d18edf8,
title = "LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial",
abstract = "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) hadan 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.",
keywords = "Amylase, Lipase, Pancreatitis, Type 2 diabetes",
author = "Steinberg, {William M.} and Nauck, {Michael A.} and Bernard Zinman and Daniels, {Gilbert H.} and Bergenstal, {Richard M.} and Mann, {Johannes F E} and Ravn, {Lasse Steen} and Moses, {Alan C.} and Mette Stockner and Baeres, {Florian M M} and Marso, {Steven P.} and Buse, {John B.}",
year = "2014",
month = "11",
day = "10",
language = "English (US)",
volume = "43",
pages = "1223--1231",
journal = "Pancreas",
issn = "0885-3177",
publisher = "Lippincott Williams and Wilkins",
number = "8",

}

TY - JOUR

T1 - LEADER 3-lipase and amylase activity in subjects with type 2 diabetes baseline data from over 9000 subjects in the LEADER trial

AU - Steinberg, William M.

AU - Nauck, Michael A.

AU - Zinman, Bernard

AU - Daniels, Gilbert H.

AU - Bergenstal, Richard M.

AU - Mann, Johannes F E

AU - Ravn, Lasse Steen

AU - Moses, Alan C.

AU - Stockner, Mette

AU - Baeres, Florian M M

AU - Marso, Steven P.

AU - Buse, John B.

PY - 2014/11/10

Y1 - 2014/11/10

N2 - 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) hadan 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.

AB - 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) hadan 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.

KW - Amylase

KW - Lipase

KW - Pancreatitis

KW - Type 2 diabetes

UR - http://www.scopus.com/inward/record.url?scp=84916630493&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84916630493&partnerID=8YFLogxK

M3 - Article

C2 - 25275271

AN - SCOPUS:84916630493

VL - 43

SP - 1223

EP - 1231

JO - Pancreas

JF - Pancreas

SN - 0885-3177

IS - 8

ER -