Effect of vildagliptin versus glibenclamide on endothelial function and arterial stiffness in patients with type 2 diabetes and hypertension: a randomized controlled trial
Several trials have reported that dipeptidyl peptidase-4 (DPP-4) inhibitors, used to treat type 2 diabetes (T2DM), improve endothelial function. The current study investigated the effects of vildagliptin, a DPP-4 inhibitor, compared to glibenclamide on endothelial function, arterial stiffness, and blood pressure in patients with T2DM and hypertension.
Patients aged over 35 years with T2DM and hypertension, but without cardiovascular disease, were randomly allocated to treatment with vildagliptin (n = 25) or glibenclamide (n = 25). Both groups took metformin. Endothelial function was evaluated by peripheral artery tonometry (Endo-PAT 2000) to calculate the reactive hyperemia index (RHI) and arterial stiffness. Primary outcome was change in the RHI after 12 weeks of treatment. Twenty-four-hour non-invasive ambulatory blood pressure monitoring was performed using a Mobil-O-Graph® 24-h PWA monitor. Arterial stiffness was assessed using the augmentation index corrected for 75 bpm (AIx75), pulse wave velocity (PWV) and central systolic blood pressure (cSBP).
There were no changes in the RHI in the vildagliptin group (before 2.35 ± 0.59; after 2.24 ± 0.60; p value = NS) or in the glibenclamide group (before 2.36 ± 0.52; after 2.34 ± 0.50; p value = NS), with no differences between groups (p value = NS). There was also no difference between vildagliptin and glibenclamide treatment in respect to AIx75 (p value = NS), cSBP (p value = NS) or PWV (p value = NS).
Vildagliptin and glibenclamide similarly do not change the endothelial function and arterial stiffness after 12 weeks of treatment in diabetic and hypertensive patients without cardiovascular disease. Thus, vildagliptin has a neutral effect on vascular function.
ClinicalTrials.gov: NCT02145611, registered on 11 Jun 2013.
KeywordsArterial stiffness Diabetes Hypertension Endothelial function DPP-4 inhibitor
Ambulatory blood pressure monitoring
Body mass index
Coronary artery disease
Central systolic blood pressure
Estimated glomerular filtration ratio
- Endo-PAT 2000
Peripheral artery tonometry
High-density lipoprotein cholesterol
Low-density lipoprotein cholesterol
Pulse wave velocity
Reactive hyperemia index
Type 2 diabetes
The authors would like to thank the patients and staff who are participating in this clinical trial. We thank the reviewer David Hewitt for correcting both the English spelling and grammar and Lilian Castiglioni for the statistical analysis.
LNC-M and JFV-M contributed to the concept and design of this ongoing study. MAN and MNM take responsibility for the integrity of the data and accuracy of data analysis. LNC-M, LTG, LABF, CBC, JCY-T and JFV-M helped with the literature search. All authors read and approved the final manuscript. LNC-M and JFV-M wrote the manuscript.
This study was sponsored by Novartis. However, Novartis did not have any influence on the study design, methods, data management or analysis.
Compliance with ethical standards
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Ethics approval and consent to participate
The study protocol (no. 11665513.7.00005415) was approved by the Research Ethics Committee of State Medical School at Sao Jose do Rio Preto (FAMERP) and the study was conducted in accordance with the principles of the Helsinki Declaration.
Consent for publications
Conflict of interest
Jose F Vilela-Martin has received research grants from Novartis. The other authors do not have a conflict of interest.
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