Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Steno Diabetes Centre Copenhagen, Copenhagen, Denmark.
Diabetes Obes Metab. 2018 Dec;20(12):2899-2904. doi: 10.1111/dom.13465. Epub 2018 Aug 5.
Sodium retention and volume overload are the main determinants of poor response to renin-angiotensin-aldosterone system (RAAS) inhibition in patients with diabetes. As volume excess can exist without symptoms, biomarkers are needed to identify a priori which patients are volume overloaded and may experience less benefit from RAAS inhibition. N-terminal pro-brain natriuretic peptide (NT-proBNP) is released in the setting of increased cardiac wall stress and volume overload. We conducted a post hoc analysis among 5081 patients with type 2 diabetes mellitus participating in the ALTITUDE trial to investigate whether NTproBNP can predict the effects of additional therapy with aliskiren on cardio-renal endpoints. Aliskiren compared to placebo reduced the risk of the primary cardio-renal endpoint events by 20% (95% confidence interval [CI] 16 to 61) and 2% (95% CI -42 to 30) in the two lowest NT-proBNP tertiles, and it increased the risk by 25% (95% CI -4 to 96) in the highest NT-proBNP tertile (P value for trend = 0.009). Similar trends were observed for the cardiovascular and end-stage renal disease endpoints. Effects of aliskiren compared to placebo on safety outcomes (hyperkalaemia and hospitalization for acute kidney injury) were independent of NT-proBNP. In conclusion, baseline NT-proBNP may be used as a marker to predict the response to aliskiren with regard to cardio-renal outcomes when added to standard therapy with RAAS inhibition.
钠潴留和容量超负荷是糖尿病患者肾素-血管紧张素-醛固酮系统(RAAS)抑制反应不良的主要决定因素。由于容量过多可能无症状,因此需要生物标志物来预先确定哪些患者存在容量超负荷,并可能从 RAAS 抑制中获益较少。N 端脑利钠肽前体(NT-proBNP)在心肌壁应力和容量超负荷增加的情况下释放。我们在参加 ALTITUDE 试验的 5081 例 2 型糖尿病患者中进行了一项事后分析,以研究 NT-proBNP 是否可以预测阿利西尤单抗对心脏肾脏终点的额外治疗效果。与安慰剂相比,阿利西尤单抗降低了主要心脏肾脏终点事件的风险 20%(95%置信区间 [CI] 16 至 61)和 2%(95%CI -42 至 30)在 NT-proBNP 最低三分位数的两个,在最高 NT-proBNP 三分位数中风险增加 25%(95%CI -4 至 96)(趋势检验 P 值 = 0.009)。心血管和终末期肾病终点也观察到类似的趋势。与安慰剂相比,阿利西尤单抗对安全性结局(高钾血症和急性肾损伤住院)的影响独立于 NT-proBNP。总之,基线 NT-proBNP 可用作标志物,以预测当 RAAS 抑制标准治疗中添加阿利西尤单抗时对心脏肾脏结局的反应。