Université de Lorraine, CIC 1433, U 1116, Inserm, CHRU de Nancy, and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
Nephrology Department, CHRU de Nancy, Université de Lorraine and FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
Kidney Int. 2019 Apr;95(4):747-749. doi: 10.1016/j.kint.2018.12.006.
The Spin-D (Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease) and MiREnDa (Mineralocorticoid Receptor Antagonists in End-Stage Renal Disease) trials taken together provide the reassuring demonstration that up to 25 mg/d spironolactone is reasonably safe, provided maintenance hemodialysis patients are properly monitored and investigators use a per-protocol therapeutic algorithm to manage hyperkalemia. These results should encourage and reassure the investigators of the 2 currently ongoing, large, international, major-outcome clinical trials, both of which are using spironolactone up to 25 mg/d: ACHIEVE (Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease trial; NCT03020303) and ALCHEMIST (ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial; NCT01848639).
综合来看,Spin-D(螺内酯在透析依赖终末期肾病中的安全性和心血管疗效)和 MiREnDa(终末期肾病中矿物质皮质激素受体拮抗剂)试验提供了令人安心的证据,即每天服用 25 毫克螺内酯是合理安全的,前提是维持性血液透析患者得到适当监测,并且研究人员使用基于方案的治疗算法来管理高钾血症。这些结果应该鼓励和使正在进行的两项大型国际主要结局临床试验的研究人员放心,这两项临床试验都将使用每天 25 毫克的螺内酯:ACHIEVE(醛固酮阻断用于改善终末期肾脏病试验的健康评估;NCT03020303)和 ALCHEMIST(醛固酮拮抗剂慢性血液透析干预生存试验;NCT01848639)。