An international multicenter observational non-interventional prospective study of the efficacy of azilsartan medoxomil in overweight or obese patients with arterial hypertension (CONSTANT)

Abstract

Background

Control of arterial hypertension in obese or overweight patients is complicated since obesity directly contributes to increased blood pressure, requiring new, highly effective antihypertensive drugs. This study evaluates the efficacy of azilsartan medoxomil in real clinical practice.

Methods

An international multicenter observational non-interventional prospective study of azilsartan medoxomil was conducted in 64 clinical centers in the Russian Federation and 5 centers in the Republic of Kazakhstan. This study included 1945 obese or overweight patients with arterial hypertension. Azilsartan medoxomil was prescribed in accordance with the approved instruction for use. The decision to prescribe the drug, dose adjustment and monitoring target BP achievement belonged to the attending physicians according to their routine clinical practice. The observation period took about 6 months.

Results

The average duration of taking the medicine was 26.1 ± 4 weeks. By the fourth visit, the use of azilsartan medoxomil either in a monotherapy regimen or in free combinations resulted in a pronounced decrease in systolic and diastolic blood pressure by 30.5 ± 13.4 and 14 ± 9.4 mmHg, respectively (p < .001 compared to baseline value). A positive response to therapy was observed in 92.6% of cases (95% CI: 91.3–93.7%). Target blood pressure was achieved by 86.4% of cases (95% CI: 84.8–87.9%). During the study period 43 adverse events were recorded, the most common of which were arterial hypotension and dizziness.

Conclusions

Over the study time of 1945 patients, significant changes in blood pressure levels over time were noted, and a high frequency of response to the azilsartan therapy was observed. Adverse events related to the study drug were of mild or moderate intensity and did not require discontinuation of therapy. Thus, azilsartan medoxomil demonstrated a good safety profile and provided effective blood pressure control for overweight or obese patients with hypertension in real clinical practice.

Keywords:

• Arterial hypertension
• overweight
• obesity
• azilsartan medoxomil
• non-interventional study

Transparency

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Acknowledgements

The authors are deeply grateful to the following for participating in this project: Arina Shcherbakova for scientific advice; the MAG group (Medical Advisors Group, http://mdwrt.com), represented by Yakov Pakhomov and Irina Bode, for analyzing the data for this article; LLC Statandocs (https://statandocs.com), represented by Alexander Solodovnikov and Ekaterina Sorokina, for data analysis and preparation of the manuscript. The list of the members of the Steering Committee and a complete list of investigators is provided in the Supplementary Appendix.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentations

The study design was described previously by Zhernakova & Chazova in “The possibility of a new receptor blocker to angiotensin in improving control of hypertension. Non-intervention international multicenter observational prospective study of the use azilsartan medoxomil in patients with arterial hypertension and overweight or obesity in the Russian Federation and the Republic of Kazakhstan” [in Russian]; Systemic Hypertension. 2016; 13 (3): 6–12. DOI: 10.26442/2075-082X_13.3.6-12.

Additional information

Funding

The study was sponsored by Takeda. The study sponsor was involved in all stages of the study design, collection, analysis, and interpretation of the data, and in writing the manuscript.