Multiple modifiable risk factors for late complications in patients with diabetic kidney disease (DKD), including hyperglycemia, hypertension and dyslipidemia, increase the risk of a poor outcome. DKD is associated with a very high cardiovascular risk, which requires simultaneous treatment of these risk factors by implementing an intensified multifactorial treatment approach. However, the efficacy of a multifactorial intervention on major fatal/non-fatal cardiovascular events (MACEs) in DKD patients has been poorly investigated. Nephropathy in Diabetes type 2 (NID-2) study is a multicentre, cluster-randomized, open-label clinical trial enrolling 395 DKD patients with albuminuria, diabetic retinopathy (DR) and negative history of CV events in 14 Italian diabetology clinics. Centres were randomly assigned to either Standard-of-Care (SoC) (n = 188) or multifactorial intensive therapy (MT, n = 207) of main cardiovascular risk factors (blood pressure < 130/80 mmHg, glycated haemoglobin < 7%, LDL, HDL and total cholesterol < 100 mg/dL, > 40/50 mg/dL for men/women and < 175 mg/dL, respectively). Primary endpoint was MACEs occurrence by end of follow-up phase. Secondary endpoints included single components of primary endpoint and all-cause death. At the end of intervention period (median 3.84 and 3.40 years in MT and SoC group, respectively), targets achievement was significantly higher in MT. During 13.0 years (IQR 12.4–13.3) of follow-up, 262 MACEs were recorded (116 in MT vs. 146 in SoC). The adjusted Cox shared-frailty model demonstrated 53% lower risk of MACEs in MT arm (adjusted HR 0.47, 95%CI 0.30–0.74, P = 0.001). Similarly, all-cause death risk was 47% lower (adjusted HR 0.53, 95%CI 0.29–0.93, P = 0.027). MT induces a remarkable benefit on the risk of MACEs and mortality in high-risk DKD patients. Clinical Trial Registration ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925

中文翻译：

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多因素干预对死亡率和 MACE 的有效性和持久性：2 型糖尿病肾病的随机临床试验


糖尿病肾病 (DKD) 患者晚期并发症的多种可改变危险因素，包括高血糖、高血压和血脂异常，会增加不良预后的风险。 DKD 与非常高的心血管风险相关，需要通过实施强化的多因素治疗方法同时治疗这些危险因素。然而，多因素干预对 DKD 患者主要致命/非致命心血管事件 (MACE) 的疗效研究甚少。 2 型糖尿病肾病 (NID-2) 研究是一项多中心、整群随机、开放标签临床试验，入组了 14 家意大利糖尿病诊所的 395 名患有蛋白尿、糖尿病视网膜病变 (DR) 和心血管事件阴性病史的 DKD 患者。中心被随机分配到主要心血管危险因素（血压 < 130/80 mmHg、糖化血红蛋白 < 7%、 LDL、HDL 和总胆固醇分别为 < 100 mg/dL、男性/女性 > 40/50 mg/dL 和 < 175 mg/dL。主要终点是随访阶段结束时 MACE 的发生情况。次要终点包括主要终点的单一组成部分和全因死亡。在干预期结束时（MT 组和 SoC 组的中位数分别为 3.84 年和 3.40 年），MT 组的目标实现率显着更高。在 13.0 年 (IQR 12.4–13.3) 的随访期间，记录了 262 起 MACE（MT 中 116 例，SoC 中 146 例）。调整后的 Cox 共同衰弱模型显示，MT 组的 MACE 风险降低了 53%（调整后 HR 0.47，95%CI 0.30–0.74，P = 0.001）。同样，全因死亡风险降低了 47%（调整后 HR 0.53，95%CI 0.29–0.93，P = 0.027）。 MT 可显着降低高危 DKD 患者的 MACE 风险和死亡率。临床试验注册 ClinicalTrials.gov 编号，NCT00535925。 https://临床试验。政府/ct2/show/NCT00535925