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01.12.2012 | Study protocol | Ausgabe 1/2012 Open Access

Cardiovascular Diabetology 1/2012

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

Zeitschrift:
Cardiovascular Diabetology > Ausgabe 1/2012
Autoren:
Robert Klempfner, Jonathan Leor, Alexander Tenenbaum, Enrique Z Fisman, Ilan Goldenberg
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2840-11-60) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

IG and RK conceived the study, and participated in its design, coordination and drafted the manuscript with EF and AT. JL participated in the design of the study. All authors read and approved the final manuscript.

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.
Zusatzmaterial
Authors’ original file for figure 1
12933_2012_477_MOESM1_ESM.pdf
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