Author:
Sasso Ferdinando Carlo,Simeon Vittorio,Galiero Raffaele,Caturano Alfredo,De Nicola Luca,Chiodini Paolo,Rinaldi Luca,Salvatore Teresa,Lettieri Miriam,Nevola Riccardo,Sardu Celestino,Docimo Giovanni,Loffredo Giuseppe,Marfella Raffaele,Adinolfi Luigi Elio,Minutolo Roberto,Amelia U,Acierno C,Calatola P,Carbonara O,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,LampitellaJr 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
Nephropathy in Diabetes type 2 (NID-2) study is an open-label cluster randomized clinical trial that demonstrated that multifactorial intensive treatment reduces Major Adverse Cardiac Events (MACEs) and overall mortality versus standard of care in type 2 diabetic subjects with albuminuria and no history of cardiovascular disease. Aim of the present post-hoc analysis of NID- 2 study is to evaluate whether the number of risk factors on target associates with patient outcomes.
Methods
Intervention phase lasted four years and subsequent follow up for survival lasted 10 years. To the aim of this post-hoc analysis, the whole population has been divided into 3 risk groups: 0–1 risk factor (absent/low); 2–3 risk factors (intermediate); 4 risk factors (high). Primary endpoint was a composite of fatal and non-fatal MACEs, the secondary endpoint was all-cause death at the end of the follow-up phase.
Results
Absent/low risk group included 166 patients (52.4%), intermediate risk group 128 (40.4%) and high-risk group 23 (7.3%). Cox model showed a significant higher risk of MACE and death in the high-risk group after adjustment for confounding variables, including treatment arm (HR 1.91, 95% CI 1.04–3.52, P = 0.038 and 1.96, 95%CI 1.02–3.8, P = 0,045, respectively, vs absent/low risk group).
Conclusions
This post-hoc analysis of the NID-2 trial indicates that the increase in the number of risk factors at target correlates with better cardiovascular-free survival in patients with type 2 diabetes at high CV risk.
Clinical Trial Registration
ClinicalTrials.gov number, NCT00535925. https://clinicaltrials.gov/ct2/show/NCT00535925
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine,Endocrinology, Diabetes and Metabolism