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

Cardiovascular Diabetology

Study Protocol

Robert Klempfner¹  Ilan Goldenberg¹  Alexander Tenenbaum²  Jonathan Leor³  Enrique Z Fisman⁴ 

[1] Cardiac Rehabilitation Institute, Leviev Heart Center, Sheba Medical Center, 52621, Tel Hashomer, Israel;Cardiac Rehabilitation Institute, Leviev Heart Center, Sheba Medical Center, 52621, Tel Hashomer, Israel;Sackler Faculty of Medicine, Tel Aviv University, 69978, Ramat Aviv, Israel;Cardiovascular Diabetology Research Foundation, 58484, Holon, Israel;Cardiac Research Institute, Leviev Heart Center, Sheba Medical Center, 52621, Tel Hashomer, Israel;Sackler Faculty of Medicine, Tel Aviv University, 69978, Ramat Aviv, Israel;Cardiovascular Diabetology Research Foundation, 58484, Holon, Israel;

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

DOI  :  10.1186/1475-2840-11-60

 received in 2012-05-22, accepted in 2012-06-06,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundDiabetic 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.DesignWe 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.DiscussionDemonstrating 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.

【 授权许可】

CC BY   
© Klempfner et al.; licensee BioMed Central Ltd. 2012