Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial.
Risk Related to Pre-Diabetes Mellitus and Diabetes Mellitus in Heart Failure With Reduced Ejection Fraction: Insights From Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial.
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DOI：
10.1161/circheartfailure.115.002560
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发表时间：
2016-01
期刊：
影响因子：
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通讯作者：
PARADIGM-HF Investigators and Committees
中科院分区：
文献类型：
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作者：
Kristensen SL;Preiss D;Jhund PS;Squire I;Cardoso JS;Merkely B;Martinez F;Starling RC;Desai AS;Lefkowitz MP;Rizkala AR;Rouleau JL;Shi VC;Solomon SD;Swedberg K;Zile MR;McMurray JJ;Packer M;PARADIGM-HF Investigators and Committees
糖尿病前期的患病率及其在心力衰竭和射血分数降低患者中的后果尚不清楚。我们在前瞻性比较ARNI与ACEI对心力衰竭患者总体死亡率和发病率的影响（PARADIGM-HF）试验中对此进行了研究。我们根据糖尿病史和血糖状态检查了8399例心力衰竭和射血分数降低患者的临床结局（基线血红蛋白A1 c [HbA 1c]：<6.0% [<42 mmol/mol]，6.0%-6.4% [42-47 mmol/mol;糖尿病前期]和≥6.5% [≥48 mmol/mol;糖尿病]），在校正不良结局的已知预测因子的考克斯回归模型中。与无糖尿病史的患者相比，有糖尿病史的患者（n=2907 [35%]）发生心力衰竭住院或心血管死亡的主要复合结局的风险更高：校正风险比为1.38; 95%可信区间为1.25 - 1.52; P<0.001。HbA 1c测量结果显示，另外1106例（占总数的13%）患者患有未诊断的糖尿病，2103例（25%）患者患有糖尿病前期。未确诊糖尿病（HbA 1c，>6.5%）和已知糖尿病患者与HbA 1c <6.0%患者相比的风险比分别为1.39（1.17-1.64）; P<0.001和1.64（1.43-1.87）; P<0.001。与HbA 1c <6.0%的患者相比，糖尿病前期患者的风险也更高（风险比，1.27 [1.10-1.47]; P<0.001）。LCZ 696（沙库巴曲/缬沙坦）与依那普利相比的获益在试验中HbA 1c范围内一致。在心力衰竭和射血分数降低的患者中，心功能障碍是常见的，糖尿病前期与不良心血管结局的风险较高相关（与无糖尿病和HbA 1c <6.0%的患者相比）。与依那普利相比，LCZ 696是有益的，无论血糖状态如何。URL：http://www.clinicaltrials.gov。唯一标识符：NCT 01035255。
The prevalence of pre–diabetes mellitus and its consequences in patients with heart failure and reduced ejection fraction are not known. We investigated these in the Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial. We examined clinical outcomes in 8399 patients with heart failure and reduced ejection fraction according to history of diabetes mellitus and glycemic status (baseline hemoglobin A1c [HbA1c]: <6.0% [<42 mmol/mol], 6.0%–6.4% [42–47 mmol/mol; pre–diabetes mellitus], and ≥6.5% [≥48 mmol/mol; diabetes mellitus]), in Cox regression models adjusted for known predictors of poor outcome. Patients with a history of diabetes mellitus (n=2907 [35%]) had a higher risk of the primary composite outcome of heart failure hospitalization or cardiovascular mortality compared with those without a history of diabetes mellitus: adjusted hazard ratio, 1.38; 95% confidence interval, 1.25 to 1.52; P<0.001. HbA1c measurement showed that an additional 1106 (13% of total) patients had undiagnosed diabetes mellitus and 2103 (25%) had pre–diabetes mellitus. The hazard ratio for patients with undiagnosed diabetes mellitus (HbA1c, >6.5%) and known diabetes mellitus compared with those with HbA1c<6.0% was 1.39 (1.17–1.64); P<0.001 and 1.64 (1.43–1.87); P<0.001, respectively. Patients with pre–diabetes mellitus were also at higher risk (hazard ratio, 1.27 [1.10–1.47]; P<0.001) compared with those with HbA1c<6.0%. The benefit of LCZ696 (sacubitril/valsartan) compared with enalapril was consistent across the range of HbA1c in the trial. In patients with heart failure and reduced ejection fraction, dysglycemia is common and pre–diabetes mellitus is associated with a higher risk of adverse cardiovascular outcomes (compared with patients with no diabetes mellitus and HbA1c <6.0%). LCZ696 was beneficial compared with enalapril, irrespective of glycemic status. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255.