Division of Nephrology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.
University of Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.
Kidney360. 2021 Jan 15;2(3):425-434. doi: 10.34067/KID.0006782020. eCollection 2021 Mar 25.
Mineralocorticoid receptor antagonists reduce mortality in patients with heart failure with reduced ejection fraction and have become a standard of care in those with resistant hypertension (rHTN). Yet, their use is limited among patients with CKD, primarily due to hyperkalemia.
AMBER was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that reported that the use of the potassium-binding drug patiromer allowed a more persistent use of spironolactone in patients with CKD and rHTN. In this report, we compare the safety and efficacy of patiromer in advanced CKD as a prespecified analysis.
Of the 295 patients randomized, 66 fell into the eGFR 25 to <30 subgroup. In this subgroup, persistent use of spironolactone was seen in 19 of 34 (56%) in the placebo group and 27 of 32 (84%) in the patiromer group (absolute difference 29%; <0.02). In the eGFR 30-45 subgroup, persistent use of spironolactone was seen in 79 of 114 (69%) in the placebo group and 99 of 115 (86%) in the patiromer group (absolute difference 17%; =0.003). There was no significant interaction between eGFR subgroups (=0.46). Systolic BP reduction with spironolactone in the eGFR 25 to <30 subgroup was 6-7 mm Hg; in the eGFR 30-45 subgroup, it was 12-13 mm Hg. There was no significant interaction between eGFR subgroups on BP reduction (=0.79). Similar proportions of patients reported adverse events (59% in the eGFR 25 to <30 subgroup; 53% in the eGFR 30-45 subgroup).
Patiromer facilitates the use of spironolactone among patients with rHTN, and its efficacy and safety are comparable in those with eGFR 25 to <30 and 30-45 ml/min per 1.73 m.
Clinicaltrials.gov, NCT03071263.
醛固酮受体拮抗剂可降低射血分数降低的心力衰竭患者的死亡率，并且已成为耐药性高血压（rHTN）患者的标准治疗方法。然而，由于高钾血症，它们在 CKD 患者中的使用受到限制。
AMBER 是一项多中心、随机、双盲、安慰剂对照、平行组研究，该研究报告称，使用钾结合药物帕替络尔可使 CKD 和 rHTN 患者更持久地使用螺内酯。在本报告中，我们将作为预先指定的分析比较 patiromer 在晚期 CKD 中的安全性和疗效。
在随机分配的 295 名患者中，66 名患者的 eGFR 为 25 至<30ml/min/1.73m²。在该亚组中，安慰剂组中有 19/34（56%）持续使用螺内酯，而 patiromer 组中有 27/32（84%）持续使用螺内酯（绝对差异 29%；<0.02）。在 eGFR 为 30 至 45ml/min/1.73m²的亚组中，安慰剂组中有 79/114（69%）持续使用螺内酯，而 patiromer 组中有 99/115（86%）持续使用螺内酯（绝对差异 17%；=0.003）。eGFR 亚组之间无显著交互作用（=0.46）。螺内酯在 eGFR 为 25 至<30ml/min/1.73m²的亚组中降低收缩压 6-7mmHg；在 eGFR 为 30 至 45ml/min/1.73m²的亚组中降低收缩压 12-13mmHg。eGFR 亚组之间在降低血压方面无显著交互作用（=0.79）。报告不良事件的患者比例相似（eGFR 为 25 至<30ml/min/1.73m²的亚组为 59%；eGFR 为 30 至 45ml/min/1.73m²的亚组为 53%）。
帕替络尔可促进 rHTN 患者使用螺内酯，其疗效和安全性在 eGFR 为 25 至<30 和 30 至 45ml/min/1.73m²的患者中相似。
Clinicaltrials.gov，NCT03071263。
