DECLARE-TIMI 58: Participants' baseline characteristics
DECLARE-TIMI 58: Participants' baseline characteristics
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DOI：
10.1111/dom.13217
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发表时间：
2018-05-01
影响因子：
5.8
通讯作者：
Wiviott, Stephen D.
中科院分区：
文献类型：
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作者：
Raz, Itamar;Mosenzon, Ofri;Wiviott, Stephen D.
目的：描述在达格列净对心血管事件的影响（DECLARE-TIMI 58）试验中随机分配的参与者的基线特征，该试验是评估达格列净心血管（CV）结局的关键研究。DECLARE-TIMI 58试验将分析17160例2型糖尿病患者，随机接受达格列净（10mg /d）或匹配的安慰剂治疗。我们分析了他们的基线特征。结果：参与者的平均+/- SD年龄为63.8 +/- 6.8岁，62.6%为男性，平均+/- SD糖尿病病程为11.8 +/- 7.8年，糖化血红蛋白8.3% +/- 1.2% (67 mmol/mol +/- 9.7 mmol/mol)，体重指数32.1 +/- 6.0 kg/m(2)。随机分组包括6971例（40.6%）动脉粥样硬化性心血管疾病（CVD）患者和10189例（59.4%）CVD多重危险因素（定义为男性年龄>= 55岁或女性>= 60岁，至少有一种血脂异常、高血压或吸烟）患者。与MRF患者相比，CVD患者更年轻（62.5 +/- 8.1岁vs 64.7 +/- 5.6岁），男性更常见（72.1% vs 56.1%），二甲双胍使用较少（74.6% vs 81.2%），胰岛素使用较多（44.2% vs 36.4%），他汀类药物、阿司匹林、氯吡格雷和β受体阻滞剂使用较多（分别为82.2%、71.1%、24.7%和66.6% vs 63.7%、39.1%、1.5%和32.3%）。结论：DECLARE-TIMI 58试验预计将为广泛的2型糖尿病合并CVD或CVD MRF患者群体中，在标准护理的基础上应用达格列净治疗对CV结局的影响提供结论性数据。
Aim: To describe the baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58) trial, the pivotal study conducted to assess cardiovascular (CV) outcomes with dapagliflozin.Methods: The DECLARE-TIMI 58 trial will analyse 17 160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10 mg/d) or matching placebo. We analysed their baseline characteristics.Results: The participants' mean +/- SD age was 63.8 +/- 6.8 years, 62.6% were male, and their mean +/- SD diabetes duration was 11.8 +/- 7.8 years, glycated haemoglobin 8.3% +/- 1.2% (67 mmol/mol +/- 9.7 mmol/mol) and body mass index 32.1 +/- 6.0 kg/m(2). Randomization included 6971 (40.6%) patients with atherosclerotic CV disease (CVD), and 10 189 (59.4%) patients with multiple risk factors (MRF) for CVD (defined as men age >= 55 years or women >= 60 years, with at least one of dyslipidaemia, hypertension or smoking). Patients with CVD compared with patients with MRF were younger (62.5 +/- 8.1 vs 64.7 +/- 5.6 years), more frequently male (72.1% vs 56.1%), less often used metformin (74.6% vs 81.2%), more often used insulin (44.2% vs 36.4%), and more frequently used statins, aspirin, clopidogrel and beta-blockers (82.2%, 71.1%, 24.7% and 66.6% vs 63.7%, 39.1%, 1.5% and 32.3%, respectively).Conclusion: The DECLARE-TIMI 58 trial is expected to provide conclusive data on the effect of treatment with dapagliflozin in addition to standard of care, on CV outcomes in a broad patient population with type 2 diabetes and CVD or MRF for CVD.