Cardiovasc Diabetol:沙库巴曲缬沙坦钠片对糖尿病合并心力衰竭患者血糖的影响

2022-08-15 从医路漫漫 MedSci原创

血糖控制不佳与心力衰竭住院风险增加相关。

背景:在射血分数(HFpEF)正常的心力衰竭患者中,糖尿病是一种常见的共病,与存活率下降和心力衰竭住院或心血管死亡风险增加相关。血糖控制不佳与心力衰竭住院风险增加相关。在射血分数(HFpEF)正常的心力衰竭患者中,糖尿病是一种常见的共病,与存活率下降和心力衰竭住院或心血管死亡风险增加相关。血糖控制不佳与心力衰竭住院风险增加相关。

使用血管紧张素受体肾素抑制剂沙库巴曲缬沙坦钠片治疗可降低射血分数降低的心力衰竭患者的发病率和死亡率(HFrEF),并且对一些HFpEF患者也有益处。食品药品监督管理局(FDA)最近扩大了沙库巴曲缬沙坦钠片的适应症,用于治疗更广泛患者的慢性心力衰竭,其中左心室射血分数(LVEF)低于正常值的患者获益最大。此前,在PARADIGM-HF试验中,沙库巴曲缬沙坦钠片已被证明可降低HFrEF和糖尿病患者的HbA1c水平和胰岛素初始需求。此外,沙库比曲/缬沙坦已被证明可改善没有糖尿病或心力衰竭的肥胖患者的胰岛素敏感性。在目前的研究中,我们比较了沙库巴曲缬沙坦钠片和缬沙坦对参与PARAGON-HF试验的HFpEF和糖尿病患者的HbA1c、降糖药物的新用途和低血糖风险的影响。为了更好地了解沙库必利/缬沙坦在整个LVEF范围内对血糖控制的影响,并在更大样本中完善治疗效果的估计,我们还在PARAGON-HF和PARADIGM-HF试验的患者汇总分析中评估了这些结果。

方法:在PARAGON-HF随机对照试验中,我们比较了相对于缬沙坦而言,沙库巴曲缬沙坦钠片对HbA1c、新胰岛素治疗和低血糖的影响,并对PARAGON-HF和PARAGON-HF进行了汇总分析。

结果:在2395例患有HFpEF和糖尿病的PARAGON-HF患者中,与缬沙坦相比,沙库巴曲缬沙坦钠片降低了HbA1c(48周时HbA1c变化的基线校正组间差异:0.24%,95% CI 0.33-0.16%,P < 0.001)。从数字上看,与缬沙坦组相比,沙库巴曲缬沙坦钠片组开始新胰岛素治疗的频率较低,但差异无统计学意义(12.8%比16.1%;HR: 0.80,95%可信区间0.62–1.02,P = 0.07)。低血糖不良事件报告率较低,但在接受沙库巴曲缬沙坦钠片治疗的患者中发生率高于缬沙坦治疗组(4.2%比2.6%;风险比:1.64,95%可信区间为1.05–2.56,P = 0.030)。在对PARAGON-HF和PARADIGM-HF的汇总分析中,LVEF并未显著改变沙库巴曲缬沙坦钠片对HbA1c变化的影响(p交互作用= 0.56)。在整个LVEF范围内,与依那普利或缬沙坦相比,沙库巴曲缬沙坦钠片减少了新的胰岛素治疗(HR: 0.75,95% CI 0.63–0.89,P = 0.001)。

图1在PARAGON-HF糖尿病患者中,随机分组和随访时的平均HbA1c值。误差线代表95%的置信区间。HbA1c斜率相等的混合模型的p

表1按治疗组列出的PARAGON-HF糖尿病患者随机分组和随访时的平均HbA1c值

图2 PARAGON-HF糖尿病患者不同结果的累积发生率。胰岛素的新用途。非胰岛素类抗高血糖药物的新用途。c低血糖。HR风险比,CI置信区间

图3通过左室射血分数比较心力衰竭和糖尿病患者中的沙库必利/缬沙坦与对照治疗(PARAGON-HF中的缬沙坦和PARADIGM-HF中的依那普利)的治疗效果。HbA1c从随机分组减少到48周(n = 5241)。b胰岛素的新用途(n = 4778)。非胰岛素抗高血糖药物的新用途(n = 2232)。低血糖症(n = 6173)

结论:在所有心力衰竭和糖尿病患者中,沙库比曲/缬沙坦可降低HbA1c和新胰岛素治疗,但可能与低血糖风险稍高相关。

原文出处:Wijkman MO,  Claggett B,  Vaduganathan M,et al.Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials.Cardiovasc Diabetol 2022 Jun 18;21(1)

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    2023-04-17 docwu2019
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    2023-06-21 quxin068
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