Abstract
BackgroundPatients with type 2 diabetes present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available.Design and methodsA prospective, randomized, open-label study was performed in 60 patients with coronary artery disease (CAD) and type 2 diabetes, who participated in a cardiac rehabilitation program. After a 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. Blinded assessment of interleukin-1ß (IL-1ß, the primary endpoint), hemoglobin A1c (HbA1c), and high sensitivity C reactive protein (hsCRP), were performed at baseline and after 12 weeks.ResultsMean age of study patients was 67 ± 9 years, 75% were males, and baseline HbA1c and inflammatory markers levels were similar between the two groups. At 12 weeks of follow up, levels of IL-1ß, hsCRP, and HbA1c were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL-1ß among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p < 0.001). The hsCRP was lowered by 60% in the vildagliptin/metformin group vs. 23% in the metformin group (p < 0.01). Moreover, a significant relative reduction of the HbA1c was seen in the intervention group (7% reduction, p < 0.03).ConclusionThe addition of vildagliptin to metformin treatment in patients with type 2 diabetes and CAD led to a significant suppression of the IL-1ß elevation during follow up. A significant relative reduction of hsCRP and HbA1c in the intervention group was also observed.Trial registration NCT01604213
Highlights
Patients with type 2 diabetes present with an accelerated atherosclerotic process
There was a continuous elevation of interleukin 1 beta (IL-1ß) among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p < 0.001)
The addition of vildagliptin to metformin treatment in patients with type 2 diabetes and coronary artery disease (CAD) led to a significant suppression of the IL-1ß elevation during follow up
Summary
Patients with type 2 diabetes present with an accelerated atherosclerotic process. Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available. Diabetes mellitus (DM) is one of the leading causes of death in the USA and Europe [1, 2] Patients with ischemic heart disease (IHD) and diabetes are at a high risk for the recurrence of cardiovascular events. Diabetes is recognized as an independent risk factor for premature atherosclerosis, and for recurrent cardiovascular events in this population [7]. Much evidence supports a pivotal role for inflammation in all phases of atherosclerosis, from the initiation of the fatty streak to the culmination in acute coronary syndromes [8]. Inflammation is involved in many of the metabolic abnormalities associated with diabetes, the most important of them being insulin resistance [3, 9]
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