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Effects of a vildagliptin/metformin combination on markers of atherosclerosis, thrombosis, and inflammation in diabetic patients with coronary artery disease

DOI: 10.1186/1475-2840-11-60

Keywords: Type 2 diabetes, Vildagliptin, Metformin, Atherosclerosis, Inflammation, Interleukin-6, TNF, Atherothrombosis, Adiponectin, MMP-9, hs-CRP

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Abstract:

We plan to prospectively investigate the effects of dipeptidyl peptidase-4 inhibition with vildagliptin on a number of atherothrombotic markers and adipokines in patients with proven atherosclerosis and type 2 diabetes. The selected markers are: interleukin-6, high sensitivity C reactive protein, interleukin 1-beta, total adiponectin levels, matrix metallo-proteinase 9 and platelet reactivity testing. Sixty eligible patients will be randomized in a 2:1 ratio to vildagliptin/metformin or metformin only treatment, for a 3-month duration treatment. Blood sampling for the proposed investigations will be taken at enrollment and immediately after completion of the study period.Demonstrating antiatherothrombotic properties of dipeptidyl peptidase-4 inhibitors on proven markers is of substantial clinical significance. Coupled with their proven good safety profile these findings could translate into a significant clinical benefit.Patients with ischemic heart disease and diabetes are at a particularly high risk for the recurrence of cardiovascular events. Conversely, certain classes of oral antidiabetic medications have been shown to cause hypoglycemia as well as adverse cardiovascular effects [1-3]. Diabetes induces complex vascular changes, promoting accelerated atherosclerosis and hypercoagulability, as can be assessed indirectly by a number of markers. Principal perturbations include endothelial dysfunction, increased inflammatory plaque infiltration, adhesion molecule over-expression and adverse effects of circulating fatty acids and advanced glycosylation end products.Animal studies have suggested numerous beneficial antiatherosclerotic changes of dipeptidyl peptidase-4 inhibitors (DPP4i), well beyond the effects on blood glucose alone [4,5]. Additionally, antiremodeling effects are proposed [6]. However, this feature has not been established in a clinical setting. Concomitant treatment with a DPP4i and metformin may offer an attractive glycemic reduction modality with

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