Abstract
Introduction
Allisartan isoproxil is a novel angiotensin II type 1 receptor antagonist that has been confirmed to lower blood pressure and protect target organs effectively. However, its role in improving endothelial function and vascular damage has not been investigated yet.
Methods
Patients with initially diagnosed mild essential hypertension (BP ranging from 140/90 to 159/99 mmHg) with age from 25–75 years were randomly assigned 1:1 to either the allisartan group (allisartan 240 mg/day and lifestyle modification) or the lifestyle modification group and were followed up for 30 days. Flow-mediated dilation (FMD), brachial-ankle pulse wave velocity (baPWV) and endothelial microparticles (EMPs) were measured for evaluation of endothelial function and vascular damage. In addition, we enrolled 36 normotensive individuals as healthy control.
Results
Seventy-two mildly hypertensive patients were enrolled in this study. After 30 days of treatment, a significant increase in FMD was observed in the allisartan group (0.9 ± 0.7%, p < 0.001) and remained unchanged in the lifestyle modification group, but the difference between the two groups did not reach statistical significance (p = ns). EMPs, baPWV, SBP and DBP decreased by 251.0 ± 255.9 counts/μl (p < 0.001), 102.8 ± 84.2 cm/s (p < 0.001), 13.20 ± 3.9 mmHg (p < 0.001) and 9.35 ± 2.5 mmHg (p < 0.001), respectively, in the allisartan group, while by 21.3 ± 84.3 counts/μl (p = ns), 0.4 ± 22.0 cm/s (p = ns), 3.2 ± 6.0 mmHg (p < 0.01) and 1.0 ± 2.5 mmHg (p = ns), respectively, in the lifestyle modification group. All of the indexes above achieved statistical significance between the allisartan and lifestyle modification groups (p < 0.05). Besides, after 30 days of allisartan administration baPWV and EMPs were comparable to those measured in the healthy control group, while the difference in SBP, DBP and FMD remained significant between the allisartan and healthy control groups (p < 0.05).
Conclusion
The present study demonstrates for the first time that allisartan isoproxil exerts a favorable effect on improving endothelial function and vascular damage in patients with mild EH, making it a promising drug for management of EH.
Clinical Trial Registration
ChiCTR2000032332.
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Acknowledgements
We appreciate the patients and healthy volunteers for participating in this study.
Funding
This work was supported by the National Nature Science Foundation (31530023) of China, 973 Program (2013CB531200), and the Science and Technology Planning Project (201704020212) of Guangzhou. The journal's rapid service fee was supported by the National Nature Science Foundation (31530023) of China.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, contributed to the writing and reviewing of the manuscript, and have given final approval for the version to be published.
Author Contributions
All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. Yongqiang Fan, Yumin Qiu, Zhe Zhou, Zhichao Wang, Yuanya Liu, and Xing Liu were involved in the acquisition of data. Gaoxing Zhang and Jun Tao were involved in the conception and design of the study. Jianning Zhang was involved in the data analysis.
Disclosures
Gaoxing Zhang, Yongqiang Fan, Yumin Qiu, Zhe Zhou, Jianning Zhang, Zhichao Wang, Yuanya Liu, Xing Liu and Jun Tao have nothing to disclose.
Compliance with Ethics Guidelines
The study was performed in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use good clinical practice guidelines and the principles of the Declaration of Helsinki. The protocol was approved by all appropriate institutional review boards or independent ethics committees [The First Affiliated Hospital, Sun Yat-Sen University (Guangzhou, China)]. All patients gave informed consent before study participation.
Data Availability
The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Zhang, G., Fan, Y., Qiu, Y. et al. Allisartan Isoproxil Improves Endothelial Function and Vascular Damage in Patients with Essential Hypertension: A Single-Center, Open-Label, Randomized Controlled Trial. Adv Ther 37, 3551–3561 (2020). https://doi.org/10.1007/s12325-020-01413-y
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DOI: https://doi.org/10.1007/s12325-020-01413-y