Impact of atorvastatin plus n-3 PUFA on metabolic, inflammatory and coagulative parameters in metabolic syndrome without and with type 2 diabetes mellitus.

Aim High serum levels of low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and low levels of high-densitycholesterol (HDL) are associated to elevated incidence of cardiovascular events and to sudden death. This lipidic pattern is often observed in patients with visceral obesity such as patients with Metabolic Syndrome (MS) and Type 2 Diabetes Mellitus (T2DM) which have an increased risk of cardiovascular events. This open-label, cross-over study evaluated the efficacy of n-3 PUFA (3g/die) added to atorvastatin (20 mg) (ATV) on lipidic profile, on haemorherologic and inflammatory parameters in patients with MS without and with T2DM. Methods All patients enrolled in this study with MS (N=62; M.31/F.31) and MS-T2DM (N=60; M.30/F.30) were submitted to 4 weeks period of isocaloric diet and pharmacological wash-out before study entry. Duration time of the study was 40 weeks. After an 8-week period of atorvastatin treatment, both patients with MS and with T2DM-MS were randomized in two groups: group A switching (24-week) from ATV alone to ATV/PUFA and group B switching (24-week) from ATV/PUFA to ATV alone. Results Significant (p<0.001) reductions in low-density lipoprotein cholesterol (LDL-C), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC) and apo-B were achieved during both treatments as compared with baseline. Moreover significant lowering effects on triglycerides (p<0.01) and significant increasing effects on HDL-C and Apo-A1 (p<0.001) were observed during ATV/PUFA treatment than ATV alone. The ATV/PUFA treatment induced significant improvements in fibrinogen, factor VII (p<0.01), PAI-1 (p<0.001), blood and plasma viscosity (p<0.01) levels compared to ATV alone results. Significant reductions during ATV/PUFA on CRP (p<0.01) were observed. ATV/PUFA treatment was generally well-tolerated, with a safety profile on laboratory parameters. Conclusions In these patients with MS and T2DM-MS combined treatment with ATV plus n-3 PUFA provided strong reductions on LDL-C and TG and increase of HDL-C with evident improvement of lipidic profile. The improvement of haemorheology and inflammatory parameters together towards an antiatherogenic lipid profile is expected to have favourable effects in reducing cardiovascular risk.