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Animal evidence indicates that dipeptidyl peptidase-4 inhibitors (gliptins) have anti-inflammatory and anti-atherosclerotic effects, yet clinical data are scarcely available.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design and methods<\/jats:title><jats:p>A 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\u00a0weeks, patients were randomized in a 2:1 ratio to receive combined vildagliptin\/metformin therapy (intervention group: n\u00a0=\u00a040) vs. metformin alone (control group: n\u00a0=\u00a020) for a total of 12\u00a0weeks. Blinded assessment of interleukin-1\u00df (IL-1\u00df, the primary endpoint), hemoglobin A1c (HbA1c), and high sensitivity C reactive protein (hsCRP), were performed at baseline and after 12\u00a0weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mean age of study patients was 67\u00a0\u00b1\u00a09\u00a0years, 75% were males, and baseline HbA1c and inflammatory markers levels were similar between the two groups. At 12\u00a0weeks of follow up, levels of IL-1\u00df, hsCRP, and HbA1c were significantly lower in the intervention group as compared with the control group. There was a continuous elevation of IL-1\u00df among the control group, which was not observed in the intervention group (49 vs. 4%, respectively; p\u00a0&lt;\u00a00.001). The hsCRP was lowered by 60% in the vildagliptin\/metformin group vs. 23% in the metformin group (p\u00a0&lt;\u00a00.01). Moreover, a significant relative reduction of the HbA1c was seen in the intervention group (7% reduction, p\u00a0&lt;\u00a00.03).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The addition of vildagliptin to metformin treatment in patients with type 2 diabetes and CAD led to a significant suppression of the IL-1\u00df elevation during follow up. A significant relative reduction of hsCRP and HbA1c in the intervention group was also observed.<\/jats:p><jats:p><jats:italic>Trial registration<\/jats:italic>NCT01604213<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12933-017-0551-5","type":"journal-article","created":{"date-parts":[[2017,5,22]],"date-time":"2017-05-22T14:47:11Z","timestamp":1495464431000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["The addition of vildagliptin to metformin prevents the elevation of interleukin 1\u00df in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study"],"prefix":"10.1186","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct01604213","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Arwa","family":"Younis","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Eskenazi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronen","family":"Goldkorn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Leor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nili","family":"Naftali-Shani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique Z.","family":"Fisman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Tenenbaum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilan","family":"Goldenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Klempfner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2017,5,22]]},"reference":[{"issue":"4","key":"551_CR1","first-page":"1","volume":"65","author":"KD Kochanek","year":"2016","unstructured":"Kochanek KD, Murphy SL, Xu J, Tejada-Vera B. 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