退伍军人事务糖尿病试验（VADT）中强化血糖控制对肾脏结局的长期随访。
Long-term follow-up of intensive glycaemic control on renal outcomes in the Veterans Affairs Diabetes Trial (VADT).
机构信息
Medical Service, Endocrinology Section, Edward Hines Jr. VA Hospital, 5000 S. 5th Avenue, Building 1, (Mail code 111), Hines, IL, 60141, USA.
Cooperative Studies Program Coordinating Center, Hines, IL, USA.
出版信息
Diabetologia. 2018 Feb;61(2):295-299. doi: 10.1007/s00125-017-4473-2. Epub 2017 Nov 3.
AIMS/HYPOTHESIS: We conducted an analysis of data collected during the Veterans Affairs Diabetes Trial (VADT) and the follow-up study (VADT-F) to determine whether intensive (INT) compared with standard (STD) glycaemic control during the VADT resulted in better long-term kidney outcomes.
METHODS
VADT randomly assigned 1791 veterans from 20 Veterans Affairs (VA) medical centres who had type 2 diabetes mellitus and a mean HbA of 9.4 ± 2% (79.2 mmol/mol) at baseline to receive either INT or STD glucose control for a median of 5.6 years (randomisation December 2000 to May 2003; intervention ending in May 2008). After the trial, participants received routine care through their own physicians within the VA. This is an interim analysis of the VADT-F (June 2008 to December 2013). We collected data using VA and National databases and report renal outcomes based on serum creatinine, eGFR and urine albumin to creatinine ratio (ACR) in 1033 people who provided informed consent to participate in the VADT-F.
RESULTS
By the end of the VADT-F, significantly more people who received INT treatment during the VADT maintained an eGFR >60 ml min 1.73 m (OR 1.34 [95% CI 1.05, 1.71], p = 0.02). This benefit was most evident in those who were classified as at moderate risk (INT vs STD, RR 1.3, p = 0.03) or high risk (RR 2.3, p = 0.04) of chronic kidney disease on the Kidney Disease Improving Global Outcomes (KDIGO-CKD) at the beginning of VADT. At the end of VADT-F, significantly more people from the INT group improved to a low KDIGO risk category (RR 6.1, p = 0.002). During the VADT-F there were no significant differences between INT and STD for average HbA, blood pressure or lipid levels.
CONCLUSIONS/INTERPRETATION: After just over 11 years of follow-up, there was a 34% greater odds of maintaining an eGFR of >60 ml min 1.73 m and of improving the KDIGO category in individuals with type 2 diabetes who had received INT for a median of 5.6 years. VADT clinical trials.gov number: NCT 00032487.
目的/假设：我们对退伍军人事务糖尿病试验（VADT）和随访研究（VADT-F）期间收集的数据进行了分析，以确定 VADT 期间强化（INT）与标准（STD）血糖控制相比是否会带来更好的长期肾脏结局。
方法
VADT 随机分配了来自 20 个退伍军人事务部（VA）医疗中心的 1791 名患有 2 型糖尿病和平均 HbA1c 为 9.4±2%（79.2mmol/mol）的退伍军人，他们在基线时接受 INT 或 STD 血糖控制，中位时间为 5.6 年（随机化时间为 2000 年 12 月至 2003 年 5 月；干预于 2008 年 5 月结束）。试验结束后，参与者通过 VA 内的自己的医生接受常规护理。这是 VADT-F 的中期分析（2008 年 6 月至 2013 年 12 月）。我们使用 VA 和国家数据库收集数据，并根据血清肌酐、eGFR 和尿白蛋白与肌酐比（ACR）报告 1033 名知情同意参加 VADT-F 的人的肾脏结局。
结果
在 VADT-F 结束时，接受 INT 治疗的人中有更多人维持 eGFR>60ml/min/1.73m（OR 1.34[95%CI 1.05,1.71]，p=0.02）。这一益处在那些被归类为中度风险（INT 与 STD，RR 1.3，p=0.03）或高风险（RR 2.3，p=0.04）的患者中最为明显根据开始 VADT 时的肾脏病改善全球结局（KDIGO-CKD）分类。在 VADT-F 结束时，INT 组中有更多的人改善到 KDIGO 低风险类别（RR 6.1，p=0.002）。在 VADT-F 期间，INT 和 STD 组之间的平均 HbA、血压或血脂水平没有显著差异。
结论/解释：在随访超过 11 年后，接受中位数为 5.6 年 INT 治疗的 2 型糖尿病患者维持 eGFR>60ml/min/1.73m 和改善 KDIGO 类别的可能性增加了 34%。VADT 临床试验.gov 编号：NCT 00032487。
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