Effects of a Vildagliptin vs. Metformin on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetic Patients with Coronary Artery Disease

Background:
Diabetic patients present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors have anti-atherosclerotic effects, yet clinical data are scarcely available.

Design and methods:
a prospective, randomized, open-label study was performed in 60 patients with established coronary artery disease and type 2 diabetes, who participated in a cardiac rehabilitation program. After washout period of 3 weeks, patients were randomized in a 2:1 ratio to receive combined vildagliptin/metformin therapy (intervention group: n=40) vs. metformin alone (control group: n=20) for a total of 12 weeks. Assessment of hemoglobin A1c (HbA1c), Interleukin-1 (IL-1), high sensitivity C reactive protein (hCRP), was performed at baseline and after 12 weeks in all patients.

Results:
Mean age of study patient was 68±9 years, and 74% were males. Comorbodities, medical treatment, Baseline HbA1c and inflammatory markers tests were similar between both groups at baseline. At 12 weeks of follow up, levels of IL1, hCRP, and HbA1C were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL1 among the metformin-group (100% to 149%; p<0.001). No significant elevation was seen among the vildagliptin-group (100% to 104%; p=0.87). The hCRP was lowered by 55% after the initiation of vildagliptin, and only 20% lowering among the metformin group. A significant reduction of the HbA1C was seen in the vildagliptin group.

Conclusion:
despite being already on optimal therapy, the addition of vildaglaptin to metformin treatment in diabetic CAD patients, was associated mainly with a significant supression of the known IL-1 elevation seen among diabetes patients with CAD.