Efficacy and safety of dapagliflozin in inactive lupus nephritis: a randomized crossover trial.

This trial aims to analyse the effect and safety of dapagliflozin in inactive LN patients with residual proteinuria.

该试验旨在分析达格列净在有残余蛋白尿的非活动性LN患者中的疗效和安全性。

Methods

We recruited adult LN patients (class III, IV(±V)] without activity, with proteinuria >500 mg/24 h and an estimated glomerular filtration rate (eGFR) ≥20 ml/min, on maintenance treatment with stable renin-angiotensin-aldosterone system inhibitors and mycophenolate mofetil ≤2 g/day.

我们招募了成人类III、IV(±V)级活动性肾脏病患者，蛋白尿>500 mg/24 h，估算肾小球滤过率(eGFR)≥20 ml/min，正在接受稳定的肾素-血管紧张素-醛固酮系统抑制剂和≤2 g/天的吗替麦考酚酯维持治疗。

They were randomized to receive dapagliflozin on top of standard-of-care (SoC) therapy or not.

他们被随机分配接受标准治疗(SoC)加用达格列净或不接受。

After 6 months the groups were crossed over.

六个月后，研究组进行了交叉。

The primary endpoint is a reduction of proteinuria compared with baseline (6 and 12 months).

主要终点是与基线（6个月和12个月）相比的蛋白尿减少。

Results

From 97 screened patients, we excluded 67 due to active LN, low proteinuria or low eGFR.

在筛选的97名患者中，我们排除了67名患者，原因包括活动性 LN、低蛋白尿或低eGFR。

Thirty patients were randomized: 14 to start the treatment with dapagliflozin on top of SoC therapy and 16 to remain with the usual therapy for 6 months.

30名患者被随机分配：14名患者开始使用 dapagliflozin 加上标准治疗，另外16名患者继续接受常规治疗6个月。

Nine patients were excluded from the analysis due to new LN flares or lost to follow-up.

由于新的淋巴结肿大或失访，9名患者被排除在分析之外。

The mean age was 40.6 ± 12.3 years, 19 (90.5%) were female, none had diabetes and the mean body mass index was 26.1 ± 5.2.

平均年龄为40.6±12.3岁，19名（90.5%）为女性，均无糖尿病，平均体重指数为26.1±5.2。

The final analysis showed a significant reduction in proteinuria of -36.1% in patients after 6 months of dapagliflozin as opposed to -3.5% for those in the SoC therapy group (P = .03).

最终分析显示，接受达格列净治疗6个月后，患者的蛋白尿显著减少了36.1%，而标准治疗组的患者蛋白尿减少了3.5%（P = .03）。

There were more reported hypotension symptoms in the dapagliflozin group [7 cases (33.3%)] but no drug withdrawal and no significant changes in blood pressure or weight in the follow-up between the groups.

在达格列净组报告了更多的低血压症状[7例（33.3%）]，但在随访期间两组之间没有药物撤回，血压或体重没有显著变化。

There was one case of urinary infection in each group, but in the same patient.

每个组中都有一例尿路感染，但发生在同一名患者身上。

Conclusions

We demonstrate a significant reduction in residual proteinuria in patients with inactive LN with dapagliflozin without safety concerns.

我们展示了在非活动性狼疮性肾炎患者中，使用达格列净可以显著减少残余蛋白尿，且没有安全问题。