Abstract
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
Highlights
Numerous studies and metanalysis have shown the beneficial effect of statin therapy in cardiovascular disease (CVD) secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with diabetes mellitus (DM)
Design and setting of the study We evaluated the use of statins in a cohort of patients with T2DM complicated by nephropathy, in order to verify the effects for CVD primary prevention in this high risk population
This prospective and multicenter study shows the lack of CV protective effect of statin treatment in primary prevention in a T2DM population at very high CV risk, such as our cohort with clinical diagnosis of diabetic nephropathy
Summary
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. Cardiovascular complications account for 50–80 % of early deaths in diabetes patients. A large Danish study [1] showed that patients with DM and no prior myocardial infarction (MI) exhibited a 20 % cardiovascular death risk over a 7 years period, which is comparable to those without diabetes but prior MI. The underlying pathogenic mechanism that links diabetic nephropathy to a high risk of CVD remains unclear. This is probably associated to endothelial damage through inflammation and oxidative stress. Several studies have shown that diabetic nephropathy is a prognostic indicator of early mortality from CVD independently on the mechanisms involved in its development [9]
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