Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease.
Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease.
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DOI：
10.1186/s12933-021-01343-1
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发表时间：
2021-07-16
影响因子：
9.3
通讯作者：
NID-2 Study Group Investigators
中科院分区：
文献类型：
--
作者：
Sasso FC;Pafundi PC;Simeon V;De Nicola L;Chiodini P;Galiero R;Rinaldi L;Nevola R;Salvatore T;Sardu C;Marfella R;Adinolfi LE;Minutolo R;NID-2 Study Group Investigators
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，增加了不良预后的风险。DKD与非常高的心血管风险相关，这需要通过实施强化的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患者主要致命性/非致命性心血管事件(MACE)的有效性研究很少。2型糖尿病肾病(NID-2)研究是一项多中心、整群随机、开放标签的临床试验，在14家意大利糖尿病诊所招募了395名有蛋白尿、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的标准护理(n = 188)或多因素强化治疗(MT，n = 207)中(男性/女性分别为血压 <； 130/80；糖化血红蛋白 <； 7%，低密度脂蛋白，高密度脂蛋白和总胆固醇 <； 100m g/dl， >； 40/50m g/dl； <； 175m g/dl)。主要终点是在随访期结束时发生MACES。次要终点包括主要终点的单一成分和全因死亡。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组的目标完成率显著高于MT组。在13.0年(IQR 12.4-13.3)的随访中，共记录到262个MACE(MT组116个，SOC组146个)。调整后的COX共享-脆弱模型显示MT患者发生急性心肌梗死的风险降低53%(调整后HR为0.47，95%CI为0.30~0.74，P = 为0.001)。同样，全因死亡风险降低了47%(调整后的HR为0.53，95%CI为0.29-0.93，P = 0.027)。MT可显著降低高危DKD患者发生急性心肌梗死的风险和死亡率。临床试验注册临床试验.gov编号，NCT00535925。Https://clinicaltrials.gov/ct2/show/NCT00535925在线版本包含可在10.1186/s12933-021-01343-1上查阅的补充材料。
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 The online version contains supplementary material available at 10.1186/s12933-021-01343-1.
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影响因子：
9.3
作者：
Gyberg V;De Bacquer D;De Backer G;Jennings C;Kotseva K;Mellbin L;Schnell O;Tuomilehto J;Wood D;Rydén L;Amouyel P;Bruthans J;Conde AC;Cifkova R;Deckers JW;De Sutter J;Dilic M;Dolzhenko M;Erglis A;Fras Z;Gaita D;Gotcheva N;Goudevenos J;Heuschmann P;Laucevicius A;Lehto S;Lovic D;Miličić D;Moore D;Nicolaides E;Oganov R;Pająk A;Pogosova N;Reiner Z;Stagmo M;Störk S;Tokgözoğlu L;Vulic D;EUROASPIRE Investigators
通讯作者：
EUROASPIRE Investigators
影响因子：
6.1
作者：
Sasso, Ferdinando C.;Chiodini, Paolo;Minutolo, Roberto
通讯作者：
Minutolo, Roberto
影响因子：
158.5
作者：
Gaede, Peter;Lund-Andersen, Henrik;Pedersen, Oluf
通讯作者：
Pedersen, Oluf
影响因子：
158.5
作者：
Holman, Rury R.;Paul, Sanjoy K.;Neil, H. Andrew W.
通讯作者：
Neil, H. Andrew W.
影响因子：
5.4
作者：
Hubbard, Alan E.;Ahern, Jennifer;Satariano, William A.
通讯作者：
Satariano, William A.