Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy. A multicenter prospective 8 years follow up study

Cardiovascular Diabetology

Original Investigation

Plinio Cirillo¹  Maria Rosaria Rizzo²  Giuseppe Paolisso²  Raffaele Marfella²  Antonella Ascione³  Ferdinando Carlo Sasso³  Teresa Salvatore³  Ornella Carbonara³  Nadia Lascar⁴  Roberto Minutolo⁵  Luca De Nicola⁵ 

[1] Department of Advanced Biomedical Science, University of Naples Federico II, Naples, Italy;Department of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy;Department of Internal and Experimental Medicine ‘‘Magrassi-Lanzara’’, Second University of Naples, Naples, Italy;School of Life and Health Sciences, Aston University, Birmingham, UK;Unit of Nephrology, Second University of Naples, Naples, Italy;

关键词: CVD;    Primary prevention;    Statin;    Diabetes;    Nephropathy;   

DOI  :  10.1186/s12933-016-0463-9

 received in 2016-06-12, accepted in 2016-09-30,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundAlthough numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention.MethodsWe conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B).ResultsNotably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan–Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041–1.387, p 0.012).ConclusionsThese findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy.Trial registration ClinicalTrials.gov Identifier NCT00535925. Date of registration: September 24, 2007, retrospectively registered

【 授权许可】

CC BY   
© The Author(s) 2016