Carrero Juan Jesus, Sood Manish M, Gonzalez-Ortiz Ailema, Clase Catherine M
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Division of Nephrology, Danderyd Hospital, Department of Clinical Sciences, Karolinska Institutet, Stockholm, Sweden.
Clin Kidney J. 2023 Apr 21;16(8):1213-1220. doi: 10.1093/ckj/sfad089. eCollection 2023 Aug.
Since the 1950s, sodium polystyrene sulphonate (SPS) has been the dominant cation exchange agent prescribed for hyperkalaemia. Clinicians have had plenty of time to learn of SPS's advantages and limitations. The demands of drug regulatory agencies regarding the incorporation of medications into the market were not so stringent then as they are today, and the efficacy and safety of SPS have been questioned. In recent years, two novel cation exchangers, patiromer and sodium zirconium cyclosilicate, have received (or are in the process of receiving) regulatory approval in multiple jurisdictions globally, after scrutiny of carefully conducted trials regarding their short-term and mid-term efficacy. In this debate, we defend the view that all three agents are likely to have similar efficacy. Harms are much better understood for SPS than for newer agents, but currently there are no data to suggest that novel agents are safer than SPS. Drug choices need to consider costs, access and numbers-needed-to-treat to prevent clinically important events; for potassium exchangers, we need trials directly examining clinically important events.
自20世纪50年代以来,聚苯乙烯磺酸钠(SPS)一直是治疗高钾血症的主要阳离子交换剂。临床医生有足够的时间了解SPS的优缺点。当时药品监管机构对药品上市的要求不像现在这么严格,SPS的疗效和安全性也受到了质疑。近年来,两种新型阳离子交换剂,帕替罗姆和环硅酸锆钠,在经过对其短期和中期疗效的仔细试验审查后,已在全球多个司法管辖区获得(或正在获得)监管批准。在这场辩论中,我们支持这样一种观点,即这三种药物可能具有相似的疗效。与新型药物相比,我们对SPS的危害了解得更多,但目前没有数据表明新型药物比SPS更安全。药物选择需要考虑成本、可及性和预防临床重要事件所需的治疗人数;对于钾交换剂,我们需要直接检查临床重要事件的试验。