PDF(Pubmed)
Abstract：
UNASSIGNED: Despite the provision of renin-angiotensin-aldosterone-system inhibitors and immunosuppressive therapies, membranous nephropathy often progresses to end-stage kidney disease (ESKD). The objective of this prespecified analysis was to assess the safety and efficacy of dapagliflozin in patients with membranous nephropathy enrolled in the DAPA-CKD trial.
UNASSIGNED: Patients with an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) 200-5,000 mg/g were randomized to dapagliflozin 10 mg once daily or placebo, along with standard-of-care and followed for median 2.4 years. The primary endpoint was a composite of ≥50% sustained decline in eGFR, ESKD, or kidney or cardiovascular death. Exploratory efficacy endpoints included eGFR slope and UACR.
UNASSIGNED: Among DAPA-CKD participants with membranous nephropathy, 19 were randomized to dapagliflozin and 24 to placebo. The mean (SD) age was 59.9 ± 12.1 years, the mean eGFR was 45.7 ± 12.1 mL/min/1.73 m2, and the median UACR was 1,694.5 (25%, 75% range 891-2,582.5) mg/g. Two of 19 (11%) patients randomized to dapagliflozin and five of 24 (21%) randomized to placebo experienced the primary composite endpoint. Total and chronic mean eGFR slopes for dapagliflozin and placebo were -3.87 and -4.29 and -2.66 and -4.22 mL/min/1.73 m2/year, respectively; corresponding between-group mean differences were 0.42 and 1.57 mL/min/1.73 m2/year. Dapagliflozin reduced geometric mean (SEM) UACR relative to placebo (-29.3% ± 1.2% vs. -3.6% ± 1.1%; between-group mean difference [95% CI] -26.7 [-50.4, 8.3]). Four (21%) patients randomized to dapagliflozin and seven (29%) randomized to placebo experienced a serious adverse event.
UNASSIGNED: In membranous nephropathy, the effects of dapagliflozin on kidney disease progression and albuminuria were generally favorable; there was insufficient power to justify formal inference testing.
UNASSIGNED: Patients with an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) 200-5,000 mg/g were randomized to dapagliflozin 10 mg once daily or placebo, along with standard-of-care and followed for median 2.4 years. The primary endpoint was a composite of ≥50% sustained decline in eGFR, ESKD, or kidney or cardiovascular death. Exploratory efficacy endpoints included eGFR slope and UACR.
UNASSIGNED: Among DAPA-CKD participants with membranous nephropathy, 19 were randomized to dapagliflozin and 24 to placebo. The mean (SD) age was 59.9 ± 12.1 years, the mean eGFR was 45.7 ± 12.1 mL/min/1.73 m2, and the median UACR was 1,694.5 (25%, 75% range 891-2,582.5) mg/g. Two of 19 (11%) patients randomized to dapagliflozin and five of 24 (21%) randomized to placebo experienced the primary composite endpoint. Total and chronic mean eGFR slopes for dapagliflozin and placebo were -3.87 and -4.29 and -2.66 and -4.22 mL/min/1.73 m2/year, respectively; corresponding between-group mean differences were 0.42 and 1.57 mL/min/1.73 m2/year. Dapagliflozin reduced geometric mean (SEM) UACR relative to placebo (-29.3% ± 1.2% vs. -3.6% ± 1.1%; between-group mean difference [95% CI] -26.7 [-50.4, 8.3]). Four (21%) patients randomized to dapagliflozin and seven (29%) randomized to placebo experienced a serious adverse event.
UNASSIGNED: In membranous nephropathy, the effects of dapagliflozin on kidney disease progression and albuminuria were generally favorable; there was insufficient power to justify formal inference testing.
摘要：
■尽管提供了肾素-血管紧张素-醛固酮系统抑制剂和免疫抑制疗法，膜性肾病常进展为终末期肾病(ESKD)。这项预设分析的目的是评估达格列净在DAPA-CKD试验中纳入的膜性肾病患者中的安全性和有效性。
■估计肾小球滤过率（eGFR）为25-75mL/min/1.73m2且尿白蛋白与肌酐之比（UACR）为200-5,000mg/g的患者随机分为达格列净10mg，每日一次或安慰剂，以及标准治疗，并随访中位数2.4年。主要终点是eGFR持续下降≥50%，ESKD,或肾脏或心血管死亡。探索性疗效终点包括eGFR斜率和UACR。
■在患有膜性肾病的DAPA-CKD参与者中，19人被随机分配给达格列净，24人被随机分配给安慰剂。平均（SD）年龄为59.9±12.1岁，平均eGFR为45.7±12.1mL/min/1.73m2，中位数UACR为1,694.5（25%，75%范围891-2,582.5)mg/g。19名患者中有2名（11％）随机接受达格列净治疗，24名患者中有5名（21％）随机接受安慰剂治疗。达格列净和安慰剂的总和慢性平均eGFR斜率分别为-3.87和-4.29和-2.66和-4.22mL/min/1.73m2/年，相应的组间平均差异分别为0.42和1.57mL/min/1.73m2/年。Dapagliflozin相对于安慰剂降低了几何平均值（SEM）UACR（-29.3％±1.2％vs.-3.6%±1.1%；组间平均差[95%CI]-26.7[-50.4，8.3]）。4名（21％）随机接受达格列净治疗的患者和7名（29％）随机接受安慰剂治疗的患者经历了严重不良事件。
■在膜性肾病中，达格列净对肾脏疾病进展和白蛋白尿的影响总体上是有利的;没有足够的力量证明正式的推断测试是合理的.
■估计肾小球滤过率（eGFR）为25-75mL/min/1.73m2且尿白蛋白与肌酐之比（UACR）为200-5,000mg/g的患者随机分为达格列净10mg，每日一次或安慰剂，以及标准治疗，并随访中位数2.4年。主要终点是eGFR持续下降≥50%，ESKD,或肾脏或心血管死亡。探索性疗效终点包括eGFR斜率和UACR。
■在患有膜性肾病的DAPA-CKD参与者中，19人被随机分配给达格列净，24人被随机分配给安慰剂。平均（SD）年龄为59.9±12.1岁，平均eGFR为45.7±12.1mL/min/1.73m2，中位数UACR为1,694.5（25%，75%范围891-2,582.5)mg/g。19名患者中有2名（11％）随机接受达格列净治疗，24名患者中有5名（21％）随机接受安慰剂治疗。达格列净和安慰剂的总和慢性平均eGFR斜率分别为-3.87和-4.29和-2.66和-4.22mL/min/1.73m2/年，相应的组间平均差异分别为0.42和1.57mL/min/1.73m2/年。Dapagliflozin相对于安慰剂降低了几何平均值（SEM）UACR（-29.3％±1.2％vs.-3.6%±1.1%；组间平均差[95%CI]-26.7[-50.4，8.3]）。4名（21％）随机接受达格列净治疗的患者和7名（29％）随机接受安慰剂治疗的患者经历了严重不良事件。
■在膜性肾病中，达格列净对肾脏疾病进展和白蛋白尿的影响总体上是有利的;没有足够的力量证明正式的推断测试是合理的.
