The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study
Abstract Background 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. Design and methods A p...
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| Format: | Article |
| Language: | English |
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BMC
2017-05-01
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| Series: | Cardiovascular Diabetology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12933-017-0551-5 |
| _version_ | 1819168498722537472 |
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| author | Arwa Younis Dana Eskenazi Ronen Goldkorn Jonathan Leor Nili Naftali-Shani Enrique Z. Fisman Alexander Tenenbaum Ilan Goldenberg Robert Klempfner |
| author_facet | Arwa Younis Dana Eskenazi Ronen Goldkorn Jonathan Leor Nili Naftali-Shani Enrique Z. Fisman Alexander Tenenbaum Ilan Goldenberg Robert Klempfner |
| author_sort | Arwa Younis |
| collection | DOAJ |
| description | Abstract Background 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. Design and methods 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 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. Results Mean 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). Conclusion The 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 |
| first_indexed | 2024-12-22T19:04:34Z |
| format | Article |
| id | doaj.art-9c570654b3d94ea983122a4640aafa71 |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-12-22T19:04:34Z |
| publishDate | 2017-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-9c570654b3d94ea983122a4640aafa712022-12-21T18:15:51ZengBMCCardiovascular Diabetology1475-28402017-05-0116111110.1186/s12933-017-0551-5The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label studyArwa Younis0Dana Eskenazi1Ronen Goldkorn2Jonathan Leor3Nili Naftali-Shani4Enrique Z. Fisman5Alexander Tenenbaum6Ilan Goldenberg7Robert Klempfner8The Leviev Heart Center, Sheba Medical CenterSackler School of Medicine, Tel Aviv UniversityThe Leviev Heart Center, Sheba Medical CenterThe Leviev Heart Center, Sheba Medical CenterThe Leviev Heart Center, Sheba Medical CenterSackler School of Medicine, Tel Aviv UniversityThe Leviev Heart Center, Sheba Medical CenterThe Leviev Heart Center, Sheba Medical CenterThe Leviev Heart Center, Sheba Medical CenterAbstract Background 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. Design and methods 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 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. Results Mean 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). Conclusion The 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 NCT01604213http://link.springer.com/article/10.1186/s12933-017-0551-5Interleukin 1 betaVildagliptinDipeptidyl peptidase-4 inhibitorsGliptinsMetformin |
| spellingShingle | Arwa Younis Dana Eskenazi Ronen Goldkorn Jonathan Leor Nili Naftali-Shani Enrique Z. Fisman Alexander Tenenbaum Ilan Goldenberg Robert Klempfner The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study Cardiovascular Diabetology Interleukin 1 beta Vildagliptin Dipeptidyl peptidase-4 inhibitors Gliptins Metformin |
| title | The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study |
| title_full | The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study |
| title_fullStr | The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study |
| title_full_unstemmed | The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study |
| title_short | The addition of vildagliptin to metformin prevents the elevation of interleukin 1ß in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, open-label study |
| title_sort | addition of vildagliptin to metformin prevents the elevation of interleukin 1ss in patients with type 2 diabetes and coronary artery disease a prospective randomized open label study |
| topic | Interleukin 1 beta Vildagliptin Dipeptidyl peptidase-4 inhibitors Gliptins Metformin |
| url | http://link.springer.com/article/10.1186/s12933-017-0551-5 |
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