title: 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.
abstract: Although 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.
  
  
  
  We 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).
  
  
  
  Notably, 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).
  
  
  
  These 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.
authors.affiliation: Department of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy. ferdinando.sasso@unina2.it.
authors.forename: Ferdinando Carlo
authors.identifier: 0000-0002-9142-7848
authors.initials: FC
authors.lastname: Sasso
authors.affiliation: School of Life and Health Sciences, Aston University, Birmingham, UK.
authors.forename: Nadia
authors.initials: N
authors.lastname: Lascar
authors.affiliation: Department of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Ascione
authors.affiliation: Department of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy.
authors.forename: Ornella
authors.initials: O
authors.lastname: Carbonara
authors.affiliation: Unit of Nephrology, Second University of Naples, Naples, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: De Nicola
authors.affiliation: Unit of Nephrology, Second University of Naples, Naples, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Minutolo
authors.affiliation: Department of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Salvatore
authors.affiliation: Department of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Rizzo
authors.affiliation: Department of Advanced Biomedical Science, University of Naples Federico II, Naples, Italy.
authors.forename: Plinio
authors.initials: P
authors.lastname: Cirillo
authors.affiliation: Department of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Paolisso
authors.affiliation: Department of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Marfella
mesh_terms: D000368:Aged; D000553:Ambulatory Care; D015415:Biomarkers / Q000097:blood; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D003928:Diabetic Nephropathies / Q000175:diagnosis / Q000209:etiology* / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011322:Primary Prevention / Q000379:methods*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C517652:hemoglobin A1c protein, human
keywords: CVD; Diabetes; Nephropathy; Primary prevention; Statin