Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial.
Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial.
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DOI：
10.1016/s0140-6736(11)60698-3
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发表时间：
2011-07-09
期刊：
影响因子：
168.9
通讯作者：
Lauritzen, Torsten
中科院分区：
文献类型：
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作者：
Griffin, Simon J.;Borch-Johnsen, Knut;Davies, Melanie J.;Khunti, Kamlesh;Rutten, Guy E. H. M.;Sandbaek, Annelli;Sharp, Stephen J.;Simmons, Rebecca K.;van den Donk, Maureen;Wareham, Nicholas J.;Lauritzen, Torsten
对多种心血管危险因素进行强化治疗可以使已确诊的2型糖尿病患者的死亡率减半。我们研究了筛查确诊后早期多因素治疗的效果。在丹麦、荷兰和英国进行的一项实用、随机分组、平行组试验中，343名全科医生被随机分配筛选年龄在40-69岁的登记患者，这些患者没有已知的糖尿病，随后进行糖尿病的常规护理或筛选，随后进行多种危险因素的强化治疗。主要终点是5年内的首次心血管事件，包括心血管死亡率和发病率、血运重建和非创伤性截肢。评估结果的患者和工作人员不知道实践的研究组分配。该研究在ClinicalTrials.gov注册，编号NCT 00237549。3057例筛查检测患者中有3055例（99.9%）的主要终点数据可用。平均年龄为60.3（SD 6.9）岁，平均随访时间为5.3（SD 1.6）年。心血管危险因素（HbA 1c和胆固醇浓度和血压）的改善在强化治疗组中略好但显著。首次心血管事件发生率为7·2%（13·5/1000人-年），强化治疗组为8·5%，（15·9/1000人-年）全因死亡率分别为6.2%（11.6/1000人年）和6.7%（12.5/1000人年; 0.91，0.69 ~ 1.21）。促进2型糖尿病患者早期强化管理的干预措施与心血管事件和死亡发生率的小幅、非显著性降低相关。国家卫生服务丹麦、丹麦战略研究理事会、丹麦全科医学研究基金会、丹麦评价和卫生技术评估中心、丹麦国家卫生委员会、丹麦医学研究理事会、奥胡斯大学研究基金会、威康信托基金、英国医学研究理事会、英国NIHR卫生技术评估计划、英国国家卫生服务研发部、英国国家卫生研究所、朱利叶斯健康科学和初级保健中心，大学医学中心，乌得勒支，诺和诺德，阿斯特拉，辉瑞，葛兰素史克，施维雅，HemoCue，默克。
Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening. In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40–69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice's study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549. Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA1c and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65–1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69–1·21), respectively. An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death. National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck.