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Open Access Highly Accessed Study protocol

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

Robert Klempfner1*, Jonathan Leor2, Alexander Tenenbaum134, Enrique Z Fisman34 and Ilan Goldenberg1

Author Affiliations

1 Cardiac Rehabilitation Institute, Leviev Heart Center, Sheba Medical Center, 52621, Tel Hashomer, Israel

2 Cardiac Research Institute, Leviev Heart Center, Sheba Medical Center, 52621, Tel Hashomer, Israel

3 Sackler Faculty of Medicine, Tel Aviv University, 69978, Ramat Aviv, Israel

4 Cardiovascular Diabetology Research Foundation, 58484, Holon, Israel

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Cardiovascular Diabetology 2012, 11:60  doi:10.1186/1475-2840-11-60

Published: 6 June 2012

Abstract

Background

Diabetic patients present with an accelerated atherosclerotic process and an increased risk for future cardiovascular events. In addition to the risk imposed by the disease itself, pharmacological treatment adds also a sizable risk, especially if certain classes of antidiabetic drugs are employed. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors have anti-atherosclerotic effects, yet clinical data are scarcely available.

Design

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.

Discussion

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.

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