Azilsartan at the start of arterial hypertension therapy: Results of EDARGO-START study
Abstract. Arterial hypertension (AH) remains the leading cause of cardiovascular morbidity and mortality. At the same time, blood pressure (BP) control in real clinical practice remains insufficient. Current guidelines emphasize the importance of effective initial therapy of this disease, but the choice of the optimal renin-angiotensin-aldosterone system blocker remains controversial. The aim: to compare the efficacy and safety of azilsartan medoxomil and angiotensin-converting enzyme (ACE) inhibitors prescribed as initial therapy in previously untreated patients with AH. Material and methods. EDARGO-START is a multicenter, prospective, non-interventional study performed in Russia in 2024–2025. The study included 359 patients with stage 1–2 essential AH and was followed for 12 weeks. Participants received azilsartan medoxomil at doses of 20–80 mg or an ACE inhibitor (mono- or combination therapy). Dynamics of office BP and indexes of daily BP monitoring, frequency of achieving its target values, tolerability and safety of therapy were assessed. Results. All groups demonstrated significant reductions in office systolic (by 22–28 mmHg) and diastolic (by 12–15 mmHg) BP by the 12th week. More than 90% of patients achieved the target BP level of < 140/90 mmHg, and approximately 50% achieved the target BP level of < 130/80 mmHg, with no intergroup differences. The greatest absolute reduction in systolic BP was observed with azilsartan 80 mg use. In a quasi-randomized analysis, azilsartan was significantly superior to ACE inhibitors in reducing systolic BP in patients with moderate to high cardiovascular risk (p <0.05). Adverse reactions were absent in all azilsartan groups, whereas they were observed in approximately 2% of patients in ACE inhibitors group. Conclusion. Azilsartan medoxomil is an effective and safe drug for initial therapy in case of AH and can be considered as a preferred antihypertensive treatment option, especially in patients with high cardiovascular risk, in real clinical practice.Karpov Yu.A., Mubarakshina O.A., Tsygankova O.V.,Chesnikova A.I., Rodionova L.V., Timoshchenko E.S., Bykov A.N., Obrezan A.G., Zakharchuk N.V., Patrikeev A.V., Tarlovskaya E.I., Nevzorova V.A., Makarova S.A.
Keywords
arterial hypertension
azilsartan medoxomil
initial therapy for arterial hypertension
angiotensin-converting enzyme inhibitors
angiotensin II receptor blockers
blood pressure control
real clinical practice
References
1. World Health Organization (WHO). Global report on hypertension: The race against a silent killer. 19 September 2023.
URL: https://www.who.int/publications/i/item/9789240081062 (date of access – 25.11.2025).
2. Баланова Ю.А., Драпкина О.М., Куценко В.А., Имаева А.Э., Концевая А.В., Максимов С.А. с соавт. Артериальная гипертония в российской популяции в период пандемии COVID-19: гендерные различия в распространенности, лечении и его эффективности. Данные исследования ЭССЕ-РФ3. Кардиоваскулярная терапия и профилактика. 2023;22(S8):105–120. (Balanova YuA, Drapkina OM, Kutsenko VA, Imaeva AE, Kontsevaya AV, Maksimov SA et al. Hypertension in the Russian population during the COVID-19 pandemic: Sex differences in prevalence, treatment and its effectiveness. Data from the ESSE-RF3 study. Kardiovaskulyarnaya terapiya i profilaktika = Cardiovascular Therapy and Prevention. 2023;22(S8):105–120 (In Russ.)).
EDN YRUNUX. https://doi.org/10.15829/1728-8800-2023-3785
3. Joynt Maddox KE, Elkind MSV, Aparicio HJ, Commodore-Mensah Y, de Ferranti SD, Dowd WN et al. Forecasting the burden of cardiovascular disease and stroke in the United States through 2050–prevalence of risk factors and disease: A Presidential Advisory from the American Heart Association. Circulation. 2024;150(4):e65–e88.
PMID: 38832505. https://doi.org/10.1161/CIR.0000000000001256
4. Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A et al. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023;41(12):1874–2071.
PMID: 37345492. https://doi.org/10.1097/HJH.0000000000003480
5. Клинические рекомендации. Артериальная гипертензия у взрослых. Общероссийская общественная организация «Российское кардиологическое общество», общероссийская общественная организация «Российское научное медицинское общество терапевтов». Рубрикатор клинических рекомендаций Минздрава России. 2024. ID: 62_3. Доступ: https://cr.minzdrav.gov.ru/view-cr/62_3 (дата обращения – 25.11.2025). (Clinical guidelines. Arterial hypertension in adults. Russian Society of Cardiology, Russian Scientific Medical Society of Internal Medicine. Rubricator of clinical guidelines of the Ministry of Healthcare of Russia. 2024. ID: 62_3. URL: https://cr.minzdrav.gov.ru/view-cr/62_3 (date of access – 25.11.2025) (In Russ.)).
6. McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C et al.; ESC Scientific Document Group. Changes in hypertension prevalence, awareness, treatment, and control rates over the past 30 years: An analysis of the Global Burden of Disease study 1990–2019. Eur Heart J. 2024;45(38):3912–4018.
PMID: 39210715. https://doi.org/10.1093/eurheartj/ehae178
7. Goupil R, Tsuyuki RT, Santesso N, Terenzi KA, Habert J, Cheng G et al. Hypertension Canada guideline for the diagnosis, risk assessment, prevention, and treatment of hypertension in adults. CMAJ. 2025;197(20):E549–E564.
PMID: 40419299. PMCID: PMC12150426. https://doi.org/10.1503/cmaj.241770
8. Writing Committee Members; Jones DW, Ferdinand KC, Taler SJ, Johnson HM, Shimbo D, Abdalla M et al. 2025 AHA / ACC / AANP /AAPA / ABC/ ACCP/ ACPM/ AGS/ AMA/ ASPC/ NMA/ PCNA/ SGIM guideline for the prevention, detection, evaluation and management of high blood pressure in adults: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Hypertension. 2025;82(10):e212–e316.
PMID: 40811516. https://doi.org/10.1161/HYP.0000000000000249
9. Chen R, Suchard MA, Krumholz HM, Schuemie MJ, Shea S, Duke J et al. Comparative first-line effectiveness and safety of ACE (angiotensin-converting enzyme) inhibitors and angiotensin receptor blockers: A multinational cohort study. Hypertension. 2021;78(3):591–603.
PMID: 34304580. PMCID: PMC8363588. https://doi.org/10.1161/HYPERTENSIONAHA.120.16667
10. Xie C, Chen R, Zhou S, Lin Y, Liu J, Su L et al. Comparative effectiveness of angiotensin-converting enzyme inhibitors versus angiotensin receptor blockers: Multidatabase target trial emulation studies. Hypertension. 2025;82(12):2072–81.
PMID: 40905143. PMCID: PMC12626536. https://doi.org/10.1161/HYPERTENSIONAHA.125.25549
11. Hu Y, Liang L, Liu S, Kung JY, Banh HL. Angiotensin-converting enzyme inhibitor induced cough compared with placebo, and other antihypertensives: A systematic review, and network meta-analysis. J Clin Hypertens (Greenwich). 2023;25(8):661–88.
PMID: 37417783. PMCID: PMC10423763. https://doi.org/10.1111/jch.14695
12. Thomopoulos C, Parati G, Zanchetti A. Effects of blood-pressure-lowering treatment in hypertension: 9. Discontinuations for adverse events attributed to different classes of antihypertensive drugs: Meta-analyses of randomized trials. J Hypertens. 2016;34(10):1921–32.
PMID: 27454050. https://doi.org/10.1097/HJH.0000000000001052
13. Derington CG, Berchie RO, Scharfstein DO, Andrews RM, Greene TH, Xu Y et al. Effect of initiation and continuous adherence to ARBs versus ACEIs on risk of adjudicated mild cognitive impairment or dementia. J Gerontol A Biol Sci Med Sci. 2025;80(7):glaf028.
PMID: 39945185. PMCID: PMC12287627. https://doi.org/10.1093/gerona/glaf028
14. Qian J, Zhang M, Chen Z. A systematic literature review and network meta-analysis of azilsartan medoxomil compared to other anti-hypertensives efficacy in lowering blood pressure amongst mild to moderate hypertensive patients. Adv Ther. 2024;41(12):4498–517.
PMID: 39412629. PMCID: PMC11550241. https://doi.org/10.1007/s12325-024-02997-5
15. Sica D, White WB, Weber MA, Bakris GL, Perez A, Cao C et al. Comparison of the novel angiotensin II receptor blocker azilsartan medoxomil vs valsartan by ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich). 2011;13(7):467–72.
PMID: 21762358. PMCID: PMC8108745. https://doi.org/10.1111/j.1751-7176.2011.00482.x
16. Bonner G, Bakris GL, Sica D, Weber MA, White WB, Perez A et al. Antihypertensive efficacy of the angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril. J Hum Hypertens. 2013;27(8):479–86.
PMID: 23514842. PMCID: PMC3715765. https://doi.org/10.1038/jhh.2013.6
17. Gitt AK, Bramlage P, Potthoff SA, Baumgart P, Mahfoud F, Buhck H et al.; EARLY Registry Group. Azilsartan compared to ACE inhibitors in anti-hypertensive therapy: One-year outcomes of the observational EARLY registry. BMC Cardiovasc Disord. 2016;16:56.
PMID: 26956148. PMCID: PMC4784379. https://doi.org/10.1186/s12872-016-0222-6
18. Троицкая Е.А., Старостина Е.С., Кобалава Ж.Д. Эффективность азилсартана медоксомила в отношении суточного профиля периферического и центрального артериального давления и артериальной ригидности у пациентов с артериальной гипертонией и сахарным диабетом 2 типа. Кардиоваскулярная терапия и профилактика. 2017;16(1):74–81. (Troitskaya EA, Starostina ES, Kobalava ZhD. Efficacy of azilsartan medoxomil on the daily profile of peripheral and central arterial pressure and arterial stiffness in hypertensives with type 2 diabetes. Kardiovaskulyarnaya terapiya i profilaktika = Cardiovascular Therapy and Prevention. 2017;16(1):74–81 (In Russ.)).
EDN: YFZRNP. https://doi.org/10.15829/1728-8800-2017-1-74-81
19. Chazova IE, Zhernakova YV. An international multicenter observational non-interventional prospective study of the efficacy of azilsartan medoxomil in overweight or obese patients with arterial hypertension (CONSTANT). Curr Med Res Opin. 2021;37(2): 185–93.
PMID: 33119420. https://doi.org/10.1080/03007995.2020.1844647
20. Недогода С.В., Чумачек Е.В., Цома В.В., Санина Т.Н., Саласюк А.С., Смирнова В.О., Попова Е.А. Возможности азилсартана медоксомила в коррекции инсулинорезистентности и уровня адипокинов при артериальной гипертензии в сравнении с ингибиторами ангиотензинпревращающего фермента. Российский кардиологический журнал. 2020;25(7):104–114. (Nedogoda SV, Chumachek EV, Tsoma VV, Sanina TN, Salasyuk AS, Smirnova VO, Popova EA. Azilsartan medoxomil for improving insulin resistance and adipokine levels in hypertension in comparison with angiotensinconverting enzyme inhibitors. Russkiy kardiologicheskiy zhurnal = Russian Journal of Cardiology. 2020;25(7):104–114 (In Russ.)).
EDN: GBQPOP. https://doi.org/10.15829/1560-4071-2020-3767
About the Authors
Yuri A. Karpov, MD, Dr. Sci. (Medicine), professor, head of the Department of angiology, E.I. Chazov National Medical Research Center of Cardiology of the Ministry of Healthcare of Russia. Address: 121552, Moscow, 15A Akademika Chazova St.E-mail: yuri_karpov@inbox.ru
ORCID: https://orcid.org/0000-0003-1480-0458
Olga A. Mubarakshina, MD, PhD (Medicine), associate professor of the Department of clinical pharmacology, N.N. Burdenko Voronezh State Medical University of the Ministry of Healtcare of Russia. Address: 394036, Voronezh, 10 Studencheskaya St.
E-mail: mubarakshina@mail.ru
ORCID: https://orcid.org/0000-0001-6799-6322
Oksana V. Tsygankova, MD, Dr. Sci. (Medicine), associate professor, professor of the Department of emergency care with endocrinology and occupational pathology of the Faculty of advanced training and doctors’ professional retraining, Novosibirsk State Medical University of the Ministry of Healthcare of Russia; senior researcher at the Research Institute for Therapy and Preventive Medicine – a branch of the Federal Research Center, Institute of Cytology and Genetics of Siberian branch of the Russian Academy of Sciences. Address: 630090, Novosibirsk, 10 Akademika Lavrentyeva Avenue.
ORCID: https://orcid.org/0000-0003-0207-7063
Anna I. Chesnikova, MD, Dr. Sci. (Medicine), professor, head of the Department of internal medicine No. 1, Rostov State Medical University of the Ministry of Healthcare of Russia, chief external physician of the Southern Federal District, chairperson of the Rostov branch of RSMSIM. Address: 344022, Rostov-on-Don, 29 per. Nakhichevansky St.
E-mail: rostov-ossn@yandex.ru
ORCID: https://orcid.org/0000-0002-9323-592X
Larisa V. Rodionova, MD, associate professor of the Institute of therapy and instrumental diagnostics, Pacific State Medical University of the Ministry of Healthcare of Russia, cardiologist at “ZDOROVYE” Medical Center LLC. Address: 690106, Vladivostok, 38 Krasnogo Znameni Avenue.
Elena S. Timoshchenko, MD, PhD (Medicine), associate professor of the Department of general medical practice and therapy, Privolzhsky Research Medical University of the Ministry of Healthcare of Russia, cardiologist, chief external cardiology specialist at the Ministry of Healthcare of Nizhny Novgorod Region, head of the Regional Cardiology Dispensary and Rheumatology Center, head of the Regional Lipid Center of City Clinical Hospital No. 5 of the Nizhny Novgorod Nizhegorodsky district. Address: 603005, Nizhny Novgorod, 34 Nesterova St.
E-mail: timoshenko.gkdo@yandex.ru
ORCID: https://orcid.org/0000-0003-2132-6467
Alexander N. Bykov, MD, PhD (Medicine), cardiologist of the highest category, head of the Department of cardiology of Sverdlovsk Regional Clinical Hospital No. 1, chief external cardiologist of the Ministry of Healthcare of Sverdlovsk Region. Address: 620102, Yekaterinburg, 185 Volgogradskaya St.
ORCID: https://orcid.org/0000-0003-0787-7908
Andrey G. Obrezan, MD, Dr. Sci. (Medicine), professor, head of the Department of hospital therapy of the Medical Institute, Saint Petersburg State University, chief physician of Moy Meditsinsky Tsentr LLC. Address: 191186, Saint Petersburg, 1/6 lit. A Cheboksarsky Lane.
Natalya V. Zakharchuk, MD, Dr. Sci. (Medicine), professor of the Institute of hospital therapy and instrumental diagnostics, Pacific State Medical University of the Ministry of Healthcare of Russia, cardiologist at Primamed+ LLC. Address: 690039, Vladivostok, 103 100-letiya Vladivostoka Avenue.
ORCID: https://orcid.org/0000-0002-5809-3989
Alexander V. Patrikeev, MD, PhD (Medicine), associate professor of the Department of cardiology, Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia, chief specialist in cardiology, deputy medical director for regional development, Medsi Group of Companies JSC. Address: 123056, Moscow, 3A Gruzinsky Lane.
E-mail: heartist@mail.ru
ORCID: https://orcid.org/0000-0001-8657-4184. SPIN-код: 3439-4848
Ekaterina I. Tarlovskaya, MD, Dr. Sci. (Medicine), professor, head of the Department of therapy and cardiology, Privolzhsky Research Medical University of the Ministry of Healthcare of Russia, chairman of the Privolzhsky district branch of EAT, deputy head of the public educational programs in medicine at the Medical Association of Nizhny Novgorod Region, board member of the Russian Society of Cardiology, board member of the Society of Heart Failure Specialists, cardiologist and therapist at City Clinical Hospital No. 38 of Nizhny Novgorod District. Address: 603000, Nizhny Novgorod, 22 Chernyshevskogo St.
ORCID: https://orcid.org/0000-0002-9659-7010
Vera A. Nevzorova, MD, Dr. Sci. (Medicine), professor, director of the Institute of therapy and instrumental diagnostics, Pacific State Medical University of the Ministry of Healthcare of Russia. Address: 690002, Vladivostok, 2 Ostryakova St.
ORCID: https://orcid.org/0000-0002-0117-0349
Svetlana A. Makarova, MD, PhD (Medicine), head of the Group, Nizhpharm JSC. Address: 603105, Nizhny Novgorod, 7 Salganskaya St.
Similar Articles
