Key result
Multifactorial intensive therapy reduces MACE ~53% vs standard care in high-risk diabetic kidney disease.
Why the study?
The efficacy of an intensified multifactorial intervention targeting multiple cardiovascular risk factors on MACEs in patients with diabetic kidney disease had been poorly investigated.
Does multifactorial intensive therapy reduce MACEs in patients with type-2 diabetic kidney disease without prior CV events?
RCT (n=395)
Open-label
Cluster-randomized
Yes
Does multifactorial intensive therapy reduce MACEs in patients with type-2 diabetic kidney disease without prior CV events?
Hazard Ratio: 0.47 (95% CI 0.3–0.74)
Absolute Event Rate: 56.1% vs 77.8%
p-value: p=0.001
Multifactorial intensive therapy significantly reduces the risk of MACEs and all-cause mortality in high-risk patients with type-2 diabetic kidney disease over long-term follow-up.
May support intensive therapy in high-risk diabetic kidney disease; leaves open need for randomized confirmation.
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
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Sasso et al. (2021) conducted an RCT in Type-2 diabetic kidney disease (n=395). Multifactorial intensive therapy vs. Standard-of-Care was evaluated on Composite of fatal and non-fatal major adverse cardiovascular events (MACEs) (HR 0.47, 95% CI 0.30-0.74, p=0.001). Multifactorial intensive therapy reduced the risk of major adverse cardiovascular events by 53% (adjusted HR 0.47) compared to standard of care in high-risk patients with type-2 diabetic kidney disease.
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