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Published on: February 28, 2013
Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2
Ferdinando Carlo Sasso1, Pia Clara Pafundi2, Vittorio Simeon3
1Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy. ferdinandocarlo.sasso@unicampania.it.
Insights
Intensive multifactorial therapy significantly reduced major cardiovascular events (MACEs) and all-cause death in patients with diabetic kidney disease (DKD). This approach offers a remarkable benefit for high-risk DKD individuals, improving outcomes and reducing mortality.
Area of Science:
- Cardiology
- Nephrology
- Endocrinology
Background:
- Diabetic kidney disease (DKD) patients face high cardiovascular risk due to modifiable factors like hyperglycemia, hypertension, and dyslipidemia.
- Simultaneous management of these risk factors is crucial for improving outcomes in DKD.
- The effectiveness of multifactorial interventions on major adverse cardiovascular events (MACEs) in DKD remains under-investigated.
Purpose of the Study:
- To evaluate the efficacy of an intensified multifactorial therapy (MT) compared to standard-of-care (SoC) in reducing MACEs in DKD patients.
- To assess the impact of MT on all-cause mortality in this high-risk population.
Main Methods:
- The Nephropathy in Diabetes type 2 (NID-2) study was a multicentre, cluster-randomized trial involving 395 DKD patients with albuminuria and diabetic retinopathy.
- Participants were assigned to either SoC or MT, targeting blood pressure, HbA1c, and lipid levels.
- The primary endpoint was MACEs occurrence, with secondary endpoints including components of MACEs and all-cause death over a median follow-up of 3.84 years.
Main Results:
- Multifactorial therapy (MT) led to significantly higher achievement of treatment targets compared to standard-of-care (SoC).
- Over 13 years of follow-up, the MT group experienced a 53% lower risk of MACEs (adjusted HR 0.47, P=0.001).
- The risk of all-cause death was also reduced by 47% in the MT arm (adjusted HR 0.53, P=0.027).
Conclusions:
- Intensified multifactorial therapy demonstrates a significant benefit in reducing MACEs and mortality in high-risk DKD patients.
- This therapeutic approach offers a remarkable improvement in cardiovascular outcomes for individuals with diabetic kidney disease.
- The findings support the implementation of comprehensive risk factor management in DKD care.
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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