恩帕列嗪降低了疾病进展高危糖尿病患者的肾脏疾病进展和心血管死亡

Iskandar Idris
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引用次数: 0

摘要

钠-葡萄糖共转运蛋白抑制剂(SGLT2i)不仅作为一种新的治疗2型糖尿病患者高血糖的方法出现,而且被证明在减少大量心代谢肾结果方面具有益处。SGLT2i,恩帕列嗪已被证明可以减少心血管死亡并改善心力衰竭的预后,但其对有疾病进展风险的慢性肾脏疾病(CKD)患者的影响尚不清楚。Empa肾脏协作小组在《新英格兰医学杂志》上发表的一项研究旨在评估恩帕利嗪治疗广泛此类患者的效果。该研究招募了估计肾小球滤过率(eGFR)在20至45之间的CKD患者 毫升/分钟/1.73 m2 体表面积,或者eGFR在45到90之间 毫升/分钟/1.73 m2 其中尿白蛋白与肌酸酐的比率至少为200。患者被随机分配接受恩帕列嗪(10 mg,每日一次)或匹配的安慰剂。主要结果是肾脏疾病进展(定义为终末期肾脏疾病,eGFR持续下降至<;10 毫升每分钟每1.73 m2,eGFR比基线持续下降≥40%,或死于肾脏原因)或死于心血管原因。6609名患者接受了随机分组。中值为2.0时 经过多年的随访,恩帕列嗪可显著降低28%的肾脏疾病进展或心血管疾病死亡。结果在患有或不患有糖尿病的患者中以及根据eGFR范围定义的亚组中是一致的。恩帕格列嗪组因任何原因住院的比率也比安慰剂组低14%,但在心力衰竭或心血管原因死亡或任何原因死亡住院的综合结果方面,组间没有显著差异。这一发现支持更广泛地使用恩帕列嗪对糖尿病患者的肾脏保护。同样令人放心的是,恩帕列嗪和安慰剂的严重不良事件发生率相似。为了优化临床安全性,本研究证据的临床实施需要肾脏和糖尿病团队之间的合作,强调SGLT2i的病假规则,并密切监测肾脏和临床结果。
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Empagliflozin reduced progression of kidney disease and cardiovascular death in patients with or without diabetes who are at high risk of disease progression

Sodium glucose co-transporter inhibitor (SGLT2i) has emerged not only as a novel therapy to manage hyperglycaemia in people with type 2 diabetes but also shown to confer benefits in reducing a host of cardio-metabolic-renal outcomes. The SGLT2i, Empagliflozin has been shown to reduce cardiovascular death and improve outcomes from heart failure, but its effect in patients with chronic kidney disease (CKD) who are at risk for disease progression are not well understood. A study published in the New England Journal Medicine by the Empa-Kidney Collaborative group was designed to assess the effects of treatment with empaglifozin in a broad range of such patients. The study recruited patients with CKD who had an estimated glomerular filtration rate (eGFR) between 20 and 45 mL/minute/1.73 m2 of body-surface area, or who had an eGFR of between 45 and 90 mL/minute/1.73 m2 with a urinary albumin-to-creatinine ratio of at least 200. Patients were randomly assigned to receive empagliflozin (10 mg once daily) or matching placebo. The primary outcome was a composite of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 mL per minute per 1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from cardiovascular causes. 6609 patients underwent randomization. During a median of 2.0 years of follow-up, Empagliflozin was associated with a significant 28% reduction in the progression of kidney disease or death from cardiovascular causes. Results were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. The rate of hospitalization from any cause was also 14% lower in the empagliflozin group than in the placebo group, but there were no significant between-group differences with respect to the composite outcome of hospitalization for heart failure or death from cardiovascular causes or death from any cause. This finding support the wider use of empagliflozin for renal protection in patients irrespective of diabetes status. Reassuringly also, the rates of serious adverse events were similar between empagliflozin and placebo. To optimize clinical safety, clinical implementation of evidence derived from this study require collaborative working between renal and diabetes teams, emphasising the sick day rules for SGLT2i as well as close monitoring of renal and clinical outcomes.

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