The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics
The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics
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DOI：
10.1002/ejhf.1548
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发表时间：
2019-07-15
影响因子：
18.2
通讯作者：
Solomon, Scott D.
中科院分区：
文献类型：
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作者：
McMurray, John J. V.;DeMets, David L.;Solomon, Scott D.
背景：这项研究的目的是：(I)报告参加达帕利嗪和预防心力衰竭不良结局(DAPA-HF)试验的患者的基线特征；(Ii)将DAPA-HF患者与当代心力衰竭(HF)登记和其他近期HF试验的参与者进行比较；(Iii)比较DAPA-HF试验中糖尿病、糖尿病前期和糖化血红蛋白(HbA1c)正常的患者。方法和结果：心力衰竭患者为纽约心脏协会功能分级=II级，左心室射血分数=6.5%。在没有已知或未诊断出糖尿病的患者中，糖尿病前期的定义为糖化血红蛋白=5.7%，其余的患者糖化血红蛋白为5.7%，定义为血糖正常。在随机调查的4774名患者(平均年龄66岁；23%为女性)中，42%已知糖尿病，3%未确诊糖尿病。在其余的人中，67%有糖尿病前期，33%的人糖化血红蛋白正常。总体而言，DAPA-HF患者总体上与最近登记和相关试验中的患者相似，并接受过高水平的背景治疗：94%的血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂/血管紧张素受体奈普利辛抑制剂，96%的β阻滞剂和71%的盐皮质激素受体拮抗剂；26%的患者使用除颤器。糖尿病患者的心力衰竭状况更差，合并发病率更高，肾损害更严重，但接受了类似的心力衰竭治疗。糖尿病患者单独接受非胰岛素降糖治疗的比例为49%，单独接受胰岛素降糖治疗的比例为11%，两者均为14%，而不接受降糖治疗的患者为26%。结论：在DAPA-HF组中随机选择的患者与其他同时代心衰患者相似，其射血分数(HFrEF)降低的登记和试验。这些患者正在接受推荐的HFrEF治疗，而糖尿病患者也接受传统的降糖治疗。因此，DAPA-HF将测试Dapagliflzin在合并和不合并糖尿病的HFrEF患者中的增量疗效和安全性。临床试验注册：编号：NCT03036124
Background The aims of this study were to: (i) report the baseline characteristics of patients enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial, (ii) compare DAPA-HF patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre-diabetes and a normal glycated haemoglobin (HbA1c) in DAPA-HF. Methods and results Adults with HF in New York Heart Association functional class >= II, a left ventricular ejection fraction = 6.5%. Among patients without known or undiagnosed diabetes, pre-diabetes was defined as a HbA1c >= 5.7% The remainder of patients, with a HbA1c < 5.7%, were defined as normoglycaemic. Of the 4774 patients (mean age 66 years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes. Of the remainder, 67% had pre-diabetes and 33% normal HbA1c. Overall, DAPA-HF patients were generally similar to those in recent registries and in relevant trials and had high levels of background therapy: 94% angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, 96% beta-blocker, and 71% mineralocorticoid receptor antagonist; 26% had a defibrillator. Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy. Patients with diabetes received non-insulin hypoglycaemic therapy alone in 49%, insulin alone in 11%, both in 14%, and none in 26%. Conclusions Patients randomized in DAPA-HF were similar to those in other contemporary HF with reduced ejection fraction (HFrEF) registries and trials. These patients were receiving recommended HFrEF therapy and those with diabetes were also treated with conventional glucose-lowering therapy. Consequently, DAPA-HF will test the incremental efficacy and safety of dapagliflozin in HFrEF patients with and without diabetes. Clinical Trial Registration: Identifier: NCT03036124