Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease
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Published:2021-07-16
Issue:1
Volume:20
Page:
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ISSN:1475-2840
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Container-title:Cardiovascular Diabetology
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language:en
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Short-container-title:Cardiovasc Diabetol
Author:
Sasso Ferdinando CarloORCID, Pafundi Pia Clara, Simeon Vittorio, De Nicola Luca, Chiodini Paolo, Galiero Raffaele, Rinaldi Luca, Nevola Riccardo, Salvatore Teresa, Sardu Celestino, Marfella Raffaele, Adinolfi Luigi Elio, Minutolo Roberto, Amelia U., Acierno C., Calatola P., Carbonara O., Caturano A., Conte G., Corigliano G., Corigliano M., D’Urso R., De Matteo A., De Nicola L., De Rosa N., Del Vecchio E., Di Giovanni G., Gatti A., Gentile S., Gesuè L., Improta L., Lampitella A., Lampitella A., Lanzilli A., Lascar N., Masi S., Mattei P., Mastrilli V., Memoli P., Minutolo R., Nasti R., Pagano A., Pentangelo M., Pisa E., Rossi E., Sasso F. C., Sorrentino S., Torella R., Troise R., Trucillo P., Turco A. A., Turco S., Zibella F., Zirpoli L.,
Abstract
Abstract
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
Funder
Ministero dell’Istruzione, dell’Università e della Ricerca
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine,Endocrinology, Diabetes and Metabolism
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