Montagnani Andrea, Frasson Stefania, Gussoni Gualberto, Manfellotto Dario
Internal Medicine, Hospital of Grosseto, 58017 Grosseto, Italy.
FADOI Research Centre, 20123 Milan, Italy.
J Clin Med. 2021 Nov 23;10(23):5483. doi: 10.3390/jcm10235483.
(1) Background: The objective of this rapid review is to assess whether new potassium binders (NPBs) could enable the optimization of RAASi therapy more than usual care or placebo in patients with or at risk of heart failure and hyperkalemia. (2) Methods: We searched for RCTs that included patients with or at risk of hyperkalemia and patients treated with Patiromer or sodium zirconium cyclosilicate (ZSC). The comparators were placebo, usual care, and potassium binders with different doses or different treatment protocols. We searched the Cochrane CENTRAL, MEDLINE, and ClinicalTrials.gov databases. The risk of bias was assessed using the Cochrane risk of bias tool for RCTs. Data were pooled using the random effects model, and the fixed effects model was used for sensitivity analysis. (3) Results: We included 12 studies with 2800 enrolled patients. Only three of these trials (412 patients) were included in the meta-analysis. NPBs seemed to have an effect on the optimization of MRA therapy, with an RR (95% CI) of 1.24 (1.09, 1.42) (moderate certainty evidence); Patiromer seemed to have an effect on MRA optimization, with an RR (95% CI) or 1.25 (1.08, 1.45) (high certainty evidence). ZSC seemed to have no effect on enabling MRA therapy, with an RR (95% CI) of 1.19 (0.89, 1.59) (low certainty evidence). The AEs in HF patients with hyperkalemia treated with Patiromer were GI disorders and hypomagnesemia. ZSC The AEs included chronic cardiac failure, hypokalemia, and edema. (4) Conclusions: This meta-analysis included three studies with a small number of patients and a short follow-up period (1-3 months). The evidence of the effect of NPBs on MRA optimization had a moderate certainty for imprecision. Data on the effect on MRA optimization and less severe AEs in long-term treatment seem to suggest the use of Patiromer for the optimization of MRA therapy in patients with or at risk of heart failure and hyperkalemia. Future adequately powered RCTs are needed to assess the benefits and potential harms of potassium binders.
（1）背景：本快速综述的目的是评估新型钾结合剂（NPBs）在心力衰竭和高钾血症患者或有风险的患者中，是否比常规治疗或安慰剂更能优化肾素-血管紧张素-醛固酮系统抑制剂（RAASi）治疗。（2）方法：我们检索了纳入高钾血症患者或有风险的患者以及接受帕替罗默或环硅酸锆钠（ZSC）治疗的患者的随机对照试验（RCTs）。比较对象为安慰剂、常规治疗以及不同剂量或不同治疗方案的钾结合剂。我们检索了Cochrane中心对照试验注册库、MEDLINE和ClinicalTrials.gov数据库。使用Cochrane随机对照试验偏倚风险工具评估偏倚风险。采用随机效应模型汇总数据，固定效应模型用于敏感性分析。（3）结果：我们纳入了12项研究，共2800名入组患者。其中只有三项试验（412名患者）纳入了荟萃分析。NPBs似乎对盐皮质激素受体拮抗剂（MRA）治疗的优化有作用，风险比（RR）（95%置信区间）为1.24（1.09，1.42）（中等确定性证据）；帕替罗默似乎对MRA优化有作用，RR（95%置信区间）为1.25（1.08，1.45）（高确定性证据）。ZSC似乎对启用MRA治疗没有作用，RR（95%置信区间）为1.19（0.89，1.59）（低确定性证据）。接受帕替罗默治疗的高钾血症心力衰竭患者的不良事件是胃肠道疾病和低镁血症。ZSC的不良事件包括慢性心力衰竭、低钾血症和水肿。（4）结论：这项荟萃分析包括三项研究，患者数量少且随访期短（1 - 3个月）。NPBs对MRA优化作用的证据因不精确性而具有中等确定性。关于长期治疗中对MRA优化作用和较轻微不良事件的数据似乎表明，对于心力衰竭和高钾血症患者或有风险的患者，使用帕替罗默来优化MRA治疗。未来需要进行有足够样本量的随机对照试验来评估钾结合剂的益处和潜在危害。
