LEADER-4：2型糖尿病合并高心血管风险患者的血压控制：LEADER随机试验的基线数据
LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial.
作者信息
Petrie John R, Marso Steven P, Bain Stephen C, Franek Edward, Jacob Stephan, Masmiquel Luis, Leiter Lawrence A, Haluzik Martin, Satman Ilhan, Omar Mohamed, Shestakova Marina, Van Gaal Luc, Mann Johannes F, Baeres Florian M M, Zinman Bernard, Poulter Neil R
机构信息
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.
出版信息
J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890.
OBJECTIVE
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.
METHODS
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).
RESULTS
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.
CONCLUSION
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.
目的
鉴于胰高血糖素样肽-1受体激动剂可降低2型糖尿病（T2DM）患者的血压（BP），我们在“利拉鲁肽在糖尿病中的作用及疗效：心血管结局评估”（LEADER）试验随机分组前，根据国际机构设定的目标，对血压控制情况进行了研究。
方法
我们分析了LEADER试验（NCT01179048）的基线数据，这是一项正在进行的3B期随机双盲安慰剂对照心血管结局试验，在来自32个国家的9340例T2DM患者中研究胰高血糖素样肽-1受体激动剂利拉鲁肽的心血管安全性[年龄（均数±标准差）64±7.2岁，体重指数32.5±6.3kg/m²，糖尿病病程12.7±8.0年]，所有患者均有心血管疾病（CVD）高风险。
结果
共有81%（n = 7592）的参与者既往有CVD，90%（n = 8408）有高血压病史。尽管在基线时使用了多种抗高血压药物，但只有51%的患者血压控制目标为低于140/85mmHg，只有26%的患者达到推荐的基线血压目标低于130/80mmHg。在单因素分析中，既往有CVD的患者使用的药物更多（P < 0.001），且血压低于无CVD的患者（137±18.8/78±10.6mmHg对140±17.7/80±9.9mmHg；P < 0.001）。在逻辑回归分析中，北美地区的患者（64%血压控制在<140/85mmHg；38%血压控制在<130/80mmHg）是血压控制的最强预测因素。
结论
这些当代数据证实，在很大一部分心血管风险高的T2DM患者中，血压控制仍不充分，尤其是在北美以外地区。LEADER试验的纵向数据可能会为这种情况下血压控制与心血管结局的关系提供进一步的见解。
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