PDF(Pubmed)
Abstract：
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.
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.
摘要：
糖尿病肾病（DKD）患者晚期并发症的多种可改变的危险因素，包括高血糖,高血压和血脂异常，增加不良结果的风险。DKD与非常高的心血管风险有关，这需要通过实施强化多因素治疗方法来同时治疗这些危险因素。然而,多因素干预对DKD患者主要致死性/非致死性心血管事件(MACE)的疗效研究甚少.
2型糖尿病肾病（NID-2）研究是一项多中心研究，集群随机化，开放标签临床试验，招募395名有蛋白尿的DKD患者，14个意大利糖尿病诊所的糖尿病视网膜病变（DR）和CV事件阴性史。中心被随机分配到标准护理(SoC)(n=188)或多因素强化治疗(MT，n=207）的主要心血管危险因素（血压<130/80mmHg，糖化血红蛋白<7%，LDL,HDL和总胆固醇<100mg/dL，男性/女性>40/50mg/dL，<175mg/dL，分别)。主要终点是随访期结束时的MACE发生率。次要终点包括主要终点和全因死亡的单一成分。
在干预期结束时（MT和SoC组的中位数为3.84和3.40年，分别)，MT的目标实现明显更高。在13.0年(IQR12.4-13.3)的随访期间，记录了262个MACE(116个MT与146在SoC中)。调整后的Cox共享虚弱模型显示MT组MACEs风险降低53%(调整后HR0.47,95CI0.30-0.74,P=0.001)。同样，全因死亡风险降低47%(校正后HR0.53,95CI0.29-0.93,P=0.027).
MT对高危DKD患者的MACE风险和死亡率具有显著的益处。临床试验注册ClinicalTrials.gov编号，NCT00535925。https://clinicaltrials.gov/ct2/show/NCT00535925.
2型糖尿病肾病（NID-2）研究是一项多中心研究，集群随机化，开放标签临床试验，招募395名有蛋白尿的DKD患者，14个意大利糖尿病诊所的糖尿病视网膜病变（DR）和CV事件阴性史。中心被随机分配到标准护理(SoC)(n=188)或多因素强化治疗(MT，n=207）的主要心血管危险因素（血压<130/80mmHg，糖化血红蛋白<7%，LDL,HDL和总胆固醇<100mg/dL，男性/女性>40/50mg/dL，<175mg/dL，分别)。主要终点是随访期结束时的MACE发生率。次要终点包括主要终点和全因死亡的单一成分。
在干预期结束时（MT和SoC组的中位数为3.84和3.40年，分别)，MT的目标实现明显更高。在13.0年(IQR12.4-13.3)的随访期间，记录了262个MACE(116个MT与146在SoC中)。调整后的Cox共享虚弱模型显示MT组MACEs风险降低53%(调整后HR0.47,95CI0.30-0.74,P=0.001)。同样，全因死亡风险降低47%(校正后HR0.53,95CI0.29-0.93,P=0.027).
MT对高危DKD患者的MACE风险和死亡率具有显著的益处。临床试验注册ClinicalTrials.gov编号，NCT00535925。https://clinicaltrials.gov/ct2/show/NCT00535925.
