The number of risk factors not at target is associated with cardiovascular risk in a type 2 diabetic population with albuminuria in primary cardiovascular prevention. Post-hoc analysis of the NID-2 trial.

Autor: Sasso FC; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy. ferdinandocarlo.sasso@unicampania.it., Simeon V; Department of Physical and Mental Health and Preventive Medicine, Medical Statistics Unit, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Galiero R; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Caturano A; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., De Nicola L; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Chiodini P; Department of Physical and Mental Health and Preventive Medicine, Medical Statistics Unit, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Rinaldi L; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Salvatore T; Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Via De Crecchio 7, 80138, Naples, Italy., Lettieri M; Division of Cardiovascular Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, 3.31 Core Technology Facility, 46 Grafton Street, Manchester, M13 9NT, UK., Nevola R; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Sardu C; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Docimo G; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Loffredo G; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Marfella R; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Adinolfi LE; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy., Minutolo R; Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Jazyk: angličtina
Zdroj: Cardiovascular diabetology [Cardiovasc Diabetol] 2022 Nov 07; Vol. 21 (1), pp. 235. Date of Electronic Publication: 2022 Nov 07.
DOI: 10.1186/s12933-022-01674-7
Abstrakt: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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