TY - JOUR
T1 - LEADER 7
T2 - Cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ
AU - Rutten, Guy E H M
AU - Tack, Cees J.
AU - Pieber, Thomas R.
AU - Comlekci, Abdurrahman
AU - Ørsted, David Dynnes
AU - Baeres, Florian M M
AU - Marso, Steven P.
AU - Buse, John B.
N1 - Funding Information:
The authors are grateful to Watermeadow Medical, an Ashfield company (supported by Novo Nordisk), for proofreading and editing assistance. Henrik Wachmann, Department of Biostatistics, Novo Nordisk, Denmark, assisted with the statistical analyses; and Rimke Vos, Ph. D. Julius Center University Medical Center Utrecht, assisted with writing part of the ‘Research design and methods’section. The LEADER trial is sponsored by Novo Nordisk, Denmark. The authors did not receive any funding for writing this manuscript.
Publisher Copyright:
© 2016 The Author(s).
PY - 2016/6/2
Y1 - 2016/6/2
N2 - Aims: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. Methods: Baseline data, stratified for prior cardiovascular disease (CVD), were compared using multivariable logistic regression analysis to establish whether region is an independent determinant of achieved targets for glycated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL)-cholesterol. Results: Independent of CVD history, US participants were more often of non-White origin and had a longer history of type 2 diabetes, higher body weight, and higher baseline HbA1c. They had substantially lower systolic and diastolic BP, and a marginally lower LDL-cholesterol level. Fewer US participants were diagnosed with left ventricular dysfunction. In the largest group of patients, those with prior CVD and the highest cardiovascular risk, US participants were more often female, had a higher waist circumference, and had a decreased estimated glomerular filtration rate, but less frequently prior myocardial infarction or angina pectoris. Conclusions: There were baseline differences between US and European participants. These differences may result from variation in regional targets for cardiovascular risk factor management, and should be considered in the analysis and reporting of the trial results. Clinical trial identifier: ClinicalTrials.gov,
AB - Aims: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity. Methods: Baseline data, stratified for prior cardiovascular disease (CVD), were compared using multivariable logistic regression analysis to establish whether region is an independent determinant of achieved targets for glycated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL)-cholesterol. Results: Independent of CVD history, US participants were more often of non-White origin and had a longer history of type 2 diabetes, higher body weight, and higher baseline HbA1c. They had substantially lower systolic and diastolic BP, and a marginally lower LDL-cholesterol level. Fewer US participants were diagnosed with left ventricular dysfunction. In the largest group of patients, those with prior CVD and the highest cardiovascular risk, US participants were more often female, had a higher waist circumference, and had a decreased estimated glomerular filtration rate, but less frequently prior myocardial infarction or angina pectoris. Conclusions: There were baseline differences between US and European participants. These differences may result from variation in regional targets for cardiovascular risk factor management, and should be considered in the analysis and reporting of the trial results. Clinical trial identifier: ClinicalTrials.gov,
KW - Cardiovascular outcome trial
KW - External validity
KW - Generalizability
KW - Heterogeneity
KW - Type 2 diabetes
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U2 - 10.1186/s13098-016-0153-5
DO - 10.1186/s13098-016-0153-5
M3 - Article
C2 - 27274772
AN - SCOPUS:84971501056
SN - 1758-5996
VL - 8
JO - Diabetology and Metabolic Syndrome
JF - Diabetology and Metabolic Syndrome
IS - 1
M1 - 37
ER -