Twelve-week randomized study to compare the effect of vildagliptin vs. glibenclamide both added-on to metformin on endothelium function in patients with type 2 diabetes and hypertension.

Luciana Neves Cosenso-Martin,Débora Dada Martineli,Marcelo Arruda Nakazone,Cláudia Bernardi Cesarino,José Fernando Vilela-Martin,José Paulo Cipullo,Luiz Tadeu Giollo-Júnior

doi:10.1186/s13098-015-0062-z

Luciana Neves Cosenso-Martin, Débora Dada Martineli + Show 5 more

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https://doi.org/10.1186/s13098-015-0062-z

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Abstract

BackgroundVildagliptin, a DPP-4 inhibitor widely used for the treatment of type 2 diabetes mellitus (T2DM), shows beneficial effects on endothelial function. This study aims to evaluate the effect of vildagliptin on endothelial function and arterial stiffness in patients with T2DM and hypertension.MethodsFifty over 35-year-old patients with T2DM and hypertension, without cardiovascular disease, will be randomly allocated to two groups: group 1 will receive vildagliptin added-on to metformin and group 2, glibenclamide added-on to metformin. Biochemical tests (glycemia, glycated hemoglobin, total cholesterol, high-density lipoprotein cholesterol, triglycerides, creatinine, alanine aminotransferase, ultrasensitive C-reactive protein, and microalbuminuria), 24-h non-invasive ambulatory blood pressure monitoring, and assessment of endothelial function and arterial stiffness will be performed in both groups before and after 12 weeks of treatment. The endothelial function will be assessed by peripheral arterial tonometry, which measures the reactive hyperemia index (vasodilation), and arterial stiffness will be evaluated by applanation tonometry. All analysis will be performed using SPSS Statistical Software. For all analysis, a 2-sided P < 0.05 will be considered statistically significant.ResultsThe study started in December 2013 and patient recruitment is programed until October 2015. The expected results are that vildagliptin will improve the endothelial function in patients with T2DM and hypertension compared to glibenclamide treatment, independently of glycemic control.ConclusionsIt is expected that this DPP-4 inhibitor will improve endothelial function in patients with T2 DM.Trial registration: Clinical Trials NCT02145611, registered on 11 Jun 2013

Highlights

Vildagliptin, a dipeptidyl peptidase-4 enzyme (DPP-4) inhibitor widely used for the treatment of type 2 diabetes mellitus (T2DM), shows beneficial effects on endothelial function
Using the non-invasive Endo-peripheral arterial tonometry (PAT) 2000 device and radial artery applanation tonometry, the purpose of this study is to evaluate the effect of vildagliptin compared to glibenclamide both added-on to metformin on endothelial function and arterial stiffness in patients with T2DM and hypertension
It was designed to assess the effect of vildagliptin (100 mg/day b.i.d.) on endothelial function in patients with T2DM and hypertension compared to glibenclamide (5–20 mg/day depending on glycemic control)

Summary

Introduction

Vildagliptin, a DPP-4 inhibitor widely used for the treatment of type 2 diabetes mellitus (T2DM), shows beneficial effects on endothelial function. This study aims to evaluate the effect of vildagliptin on endothelial function and arterial stiffness in patients with T2DM and hypertension. As the number of elderly population is continuously growing around the world, in the two to three decades there will be a 200 % increase in the number of individuals with ages >65 years. Endothelial dysfunction is an independent predictor for future CVD in patients with T2DM [8] and is considered an early marker of vascular complications [9]. It is involved in the atherogenesis that occurs in the early stages of coronary artery disease (CAD) [10, 11]. The mechanisms of impaired endothelial function in diabetes are: reduced bioavailability of nitric oxide (NO), diminished endothelium-dependent vasodilatation, impaired barrier function, inflammatory activation, and a procoagulant state [12]

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