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J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890.

LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.

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aInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK bDivision of Cardiology, Department of Internal Medicine, University of Texas Southwestern, Dallas, Texas, USA cInstitute of Life Science, College of Medicine, Swansea University Medical School, Swansea, UK dMossakowski Medical Research Centre, Polish Academy of Sciences eDepartment of Internal Diseases, Endocrinology and Diabetology, Central Clinical Hospital MSW, Warsaw, Poland fKardio Metabolischen Instituts, Villingen-Schwenningen, Germany gEndocrinology and Nutrition Department, Hospital Son Llàtzer, University Institute of Health Science Research (IUNICS)-Universitat de les Illes Balears, Palma de Mallorca, Spain hDivisions of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Ontario, Canada i1st Faculty of Medicine and General University Hospital, Charles University in Prague, Prague, Czech Republic jDivision of Endocrinology and Metabolism, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey kDepartment of Diabetes and Endocrinology, Nelson R Mandela School of Medicine, University of KwaZulu Natal, South Africa lEndocrinology Research Centre, Diabetes Institute mI.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation nFaculty of Medicine, Antwerp University Hospital, Antwerp, Belgium oDepartment of Nephrology, Hypertension & Rheumatology, Friedrich Alexander University of Erlangen, Munchen, Germany pNovo Nordisk, A/S, Bagsvaerd, Denmark qLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada rInternational Centre for Circulatory Health, Imperial College London, London, UK.



As glucagon-like peptide-1 receptor agonists lower blood pressure (BP) in type 2 diabetes mellitus (T2DM), we examined BP control in relation to targets set by international bodies prior to randomization in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial.


We analyzed baseline data from LEADER (NCT01179048), an ongoing phase 3B, randomized, double-blind, placebo-controlled cardiovascular outcomes trial examining the cardiovascular safety of the glucagon-like peptide-1 receptor agonist liraglutide in 9340 people with T2DM from 32 countries [age (all mean ± SD) 64 ± 7.2 years, BMI 32.5 ± 6.3 kg/m, duration of diabetes 12.7 ± 8.0 years], all of whom were at high risk for cardiovascular disease (CVD).


A total of 81% (n = 7592) of participants had prior CVD and 90% (n = 8408) had a prior history of hypertension. Despite prescription of multiple antihypertensive agents at baseline, only 51% were treated to a target BP of less than 140/85 mmHg and only 26% to the recommended baseline BP target of less than 130/80 mmHg. In univariate analyses, those with prior CVD were prescribed more agents (P < 0.001) and had lower BP than those without (137 ± 18.8/78 ± 10.6 mmHg versus 140 ± 17.7/80 ± 9.9 mmHg; P < 0.001). In logistic regression analyses, residency in North America (64% treated to <140/85 mmHg; 38% treated to <130/80 mmHg) was the strongest predictor of BP control.


These contemporary data confirm that BP remains insufficiently controlled in a large proportion of individuals with T2DM at high cardiovascular risk, particularly outside North America. Longitudinal data from the LEADER trial may provide further insights into BP control in relation to cardiovascular outcomes in this condition.

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