LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ.
OBJECTIVE
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, NCT01179048.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, STR 6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
Guy E H M
GE
Rutten
Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Cees J
CJ
Tack
Division of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria.
Thomas R
TR
Pieber
Division of Endocrinology, Dokuz Eylul University Medical School, Inciralti, Izmir, Turkey.
Abdurrahman
A
Comlekci
Novo Nordisk, Søborg, Denmark.
David Dynnes
DD
Ørsted
Novo Nordisk, Søborg, Denmark.
Florian M M
FM
Baeres
Department of Internal Medicine, UT Southwestern, Dallas, TX USA.
Steven P
SP
Marso
Department of Medicine, The University of North Carolina School of Medicine, Chapel Hill, NC USA.
John B
JB
Buse
Cardiovascular outcome trial; External validity; Generalizability; Heterogeneity; Type 2 diabetes