BACKGROUND For heart failure with reduced ejection fraction (HFrEF), suboptimal use of renin-angiotensin-aldosterone system inhibitors (RAASis), including mineralocorticoid receptor antagonists (MRAs), due to hyperkalemia, may be improved by potassium binders. OBJECTIVES This prespecified analysis of the phase 3 DIAMOND (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure) trial assessed the effect of patiromer in patients with HFrEF and either current or past hyperkalemia. METHODS Patients with HFrEF and current or past (within 1 year before enrollment) hyperkalemia (serum potassium [sK+] >5.0 mmol/L) entered a single-blind, run-in phase to optimize RAASis while receiving patiromer. They were subsequently randomized, double-blind, to continue patiromer or change to placebo. RESULTS Of the 1,038 patients who completed run-in, 354 (83.9%) of 422 with current hyperkalemia and 524 (85.1%) of 616 with past hyperkalemia achieved RAASi optimization and were randomized to treatment. During the double-blind phase, patiromer lowered sK+ levels compared with placebo in both the current and past hyperkalemia subgroups: difference in adjusted mean change from baseline: -0.12 (95% CI: -0.17 to -0.07) and -0.08 (95% CI: -0.12 to -0.05), respectively; Pinteraction = 0.166. Patiromer was more effective than placebo in maintaining MRA at target dose in patients with current vs past hyperkalemia (HR: 0.45 [95% CI: 0.26-0.76] vs HR: 0.85 [95% CI: 0.54-1.32]; Pinteraction = 0.031). Adverse events were similar between subgroups. CONCLUSIONS The use of patiromer facilitates achieving target doses of RAASis in patients with HFrEF with either current or past hyperkalemia. For those with current hyperkalemia before RAASi optimization, use of patiromer may be more beneficial in helping to maintain sK+ control and achieve MRA target dose. (Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure [DIAMOND]; NCT03888066).

中文翻译：

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Patiromer 用于当前或既往高钾血症患者心力衰竭药物优化：DIAMOND 亚分析。


背景对于射血分数降低的心力衰竭（HFrEF），由于高钾血症而导致的肾素-血管紧张素-醛固酮系统抑制剂（RAASis）（包括盐皮质激素受体拮抗剂（MRA））的次优使用可能会通过钾结合剂得到改善。目的 这项预先设定的 3 期 DIAMOND（Patiromer 用于治疗接受 RAASi 治疗心力衰竭药物的受试者高钾血症）试验的分析评估了 patiromer 对 HFrEF 合并当前或过去高钾血症患者的效果。方法 患有 HFrEF 且当前或过去（入组前 1 年内）高钾血症（血清钾 [sk+]>5.0 mmol/L）的患者进入单盲磨合阶段，以在接受 patiromer 的同时优化 RAASis。随后，他们被随机、双盲地继续使用 patiromer 或改为安慰剂。结果 在完成磨合的 1,038 名患者中，422 名当前高钾血症患者中的 354 名患者（83.9%）和 616 名既往高钾血症患者中的 524 名患者（85.1%）实现了 RAASi 优化并随机接受治疗。在双盲阶段，与安慰剂相比，patiromer 在当前和过去的高钾血症亚组中均降低了 sk+ 水平：调整后的平均变化与基线的差异：-0.12（95% CI：-0.17 至 -0.07）和 -0.08（95%） CI：分别为-0.12至-0.05）； P相互作用 = 0.166。对于当前和既往高钾血症患者，Patiromer 在将 MRA 维持在目标剂量方面比安慰剂更有效（HR：0.45 [95% CI：0.26-0.76] vs HR：0.85 [95% CI：0.54-1.32]；Pinteraction = 0.031） 。亚组之间的不良事件相似。结论 使用 patiromer 有助于当前或既往高钾血症的 HFrEF 患者达到 RAASis 目标剂量。 对于 RAASi 优化前当前存在高钾血症的患者，使用 patiromer 可能更有助于维持 sK+ 控制并达到 MRA 目标剂量。 （Patiromer 用于治疗接受 RAASi 药物治疗心力衰竭的受试者的高钾血症 [DIAMOND]；NCT03888066）。