Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
DPP/DPPOS Coordinating Center, Biostatistics Center, The George Washington University, Rockville, MD, United States of America.
J Diabetes Complications. 2023 Sep;37(9):108556. doi: 10.1016/j.jdiacomp.2023.108556. Epub 2023 Jul 25.
We analyzed the incidence of kidney disease in the Diabetes Prevention Program Outcomes Study (DPPOS) by originally randomized treatment group assignment: Intensive Lifestyle (ILS), Metformin (MET) or Placebo (PLB).
The current analyses used a time-to-event approach in which the primary outcome was kidney disease, ascertained as urine albumin-to-creatinine ratio (ACR) ≥ 3.39 mg/mmol (30 mg/g) or eGFR <45 mL/min/1.73m, with confirmation required at the next visit, or adjudicated end-stage kidney disease (ESKD).
At a median of 21 years following randomization in DPP, diabetes development was reduced in both the ILS (HR 0.73 [95%CI = 0.62, 0.85]) and MET groups (HR 0.85 [0.73, 0.99]) compared to the PLB group. Although risk for developing the primary kidney disease outcome was higher among those with incident diabetes compared to those without (HR 1.81 [1.43, 2.30]), it did not differ by intervention groups (ILS vs. PLB 1.02 (0.81, 1.29); MET vs. PLB 1.08 (0.86, 1.35). There was a non-significant metformin by age interaction (p = 0.057), with metformin being beneficial for kidney disease in the younger but potentially harmful in the older participants.
Development of kidney disease was increased in participants who developed diabetes but did not differ by original treatment group assignment.
Diabetes Prevention Program (DPP) Clinical trial reg. no. NCT00004992 DPP Outcomes Study (DPPOS) Clinical trial reg. no. NCT0038727.
我们通过最初的随机治疗组分配分析了糖尿病预防计划结果研究（DPPOS）中的肾脏疾病发生率：强化生活方式（ILS）、二甲双胍（MET）或安慰剂（PLB）。
目前的分析采用了事件时间方法，主要结果是肾脏疾病，确定为尿白蛋白与肌酐比（ACR）≥3.39mg/mmol（30mg/g）或 eGFR<45mL/min/1.73m，下一次就诊时需要确认，或判定为终末期肾病（ESKD）。
在 DPP 中随机分组后的中位数为 21 年，ILS（HR 0.73 [95%CI=0.62, 0.85]）和 MET 组（HR 0.85 [0.73, 0.99]）与 PLB 组相比，糖尿病的发展均降低。尽管与无糖尿病的患者相比，发生糖尿病的患者发生主要肾脏疾病结局的风险更高（HR 1.81 [1.43, 2.30]），但干预组之间并无差异（ILS 与 PLB 1.02 [0.81, 1.29]；MET 与 PLB 1.08 [0.86, 1.35]）。二甲双胍与年龄存在非显著交互作用（p=0.057），二甲双胍对年轻参与者的肾脏疾病有益，但对老年参与者可能有害。
发生糖尿病的参与者肾脏疾病的发展增加，但与原始治疗组分配无差异。
糖尿病预防计划（DPP）临床试验注册号 NCT00004992；DPP 结果研究（DPPOS）临床试验注册号 NCT0038727。
