Clin Nephrol. 2023 Nov;100(5):224-230. doi: 10.5414/CN111143.
Sodium-glucose co-transporter 2 inhibitor (SGLT2i) has been shown to improve renal outcomes in both diabetic and non-diabetic kidney disease. However, the effect of SGLT2i on renal outcomes in patients with non-diabetic obesity is still not established.
In this double-blind, randomized controlled trial, we assigned non-diabetic patients with body mass index (BMI) ≥ 25 kg/m, persistent 24-hour urine albumin-creatinine ratio (UACR) ≥ 10 mg/gCr, and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m, who had been treated with renin-angiotensin system blockade, to canagliflozin 100 mg daily or placebo for 24 weeks. The reduction in UACR and eGFR at 12 and 24 weeks were explored. (Thai Clinical Trials Registry 20190203003).
Of 247 non-diabetic obese patients screened, 32 patients met inclusion criteria and underwent randomization. The median baseline of UACR was 69.1 mg/gCr. There were no statistically significant differences in albuminuria reduction between the groups at 12 weeks and 24 weeks. The estimated GFR in the canagliflozin group decreased significantly from baseline at 12 weeks (-5.39 mL/min/1.73m; 95% CI -9.81 to -0.97; p = 0.017) but not at 24 weeks (-1.16 mL/min/1.73m; 95% CI -5.58 to 3.26; p = 0.66), and there was no significant change from baseline in the placebo group at both 12 and 24 weeks.
Canagliflozin 100 mg daily was well tolerated but did not significantly reduce UACR in non-diabetic obese patients with microalbuminuria. However, a significant temporary decline in eGFR might reflect a subtle reduction in glomerular hyperfiltration.
钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）已被证明可改善糖尿病和非糖尿病肾病患者的肾脏结局。然而，SGLT2i 对非糖尿病肥胖患者肾脏结局的影响尚不确定。
在这项双盲、随机对照试验中，我们将体质量指数（BMI）≥25kg/m2、持续 24 小时尿白蛋白/肌酐比值（UACR）≥10mg/gCr 和估计肾小球滤过率（eGFR）≥60mL/min/1.73m2 的非糖尿病肥胖患者，随机分为每日 100mg 卡格列净或安慰剂治疗 24 周。探索了 12 周和 24 周时 UACR 和 eGFR 的降低情况。（泰国临床试验注册处 20190203003）。
在筛选的 247 例非糖尿病肥胖患者中，有 32 例符合纳入标准并接受了随机分组。UACR 的中位数基线值为 69.1mg/gCr。两组在 12 周和 24 周时蛋白尿减少无统计学差异。卡格列净组的 eGFR 在 12 周时较基线显著下降（-5.39mL/min/1.73m；95%CI-9.81 至-0.97；p=0.017），但在 24 周时无显著变化（-1.16mL/min/1.73m；95%CI-5.58 至 3.26；p=0.66），而安慰剂组在 12 周和 24 周时基线均无显著变化。
每日 100mg 卡格列净耐受性良好，但不能显著降低微量白蛋白尿的非糖尿病肥胖患者的 UACR。然而，eGFR 的显著暂时下降可能反映了肾小球高滤过的轻微减少。
