Azilsartan at the start of arterial hypertension therapy: results of EDARGO-START study

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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.

About the authors

Yuri A. Karpov

E.I. Chazov National Medical Research Center of Cardiology of the Ministry of Healthcare of Russia

Email: yuri_karpov@inbox.ru
ORCID iD: 0000-0003-1480-0458

MD, Dr. Sci. (Medicine), professor, head of the Department of angiology

Russian Federation, Moscow

Olga A. Mubarakshina

N.N. Burdenko Voronezh State Medical University of the Ministry of Healthcare of Russia

Author for correspondence.
Email: mubarakshina@mail.ru
ORCID iD: 0000-0001-6799-6322

MD, PhD (Medicine), associate professor of the Department of clinical pharmacology

Russian Federation, Voronezh

Oksana V. Tsygankova

Federal Research Center, Institute of Cytology and Genetics of Siberian branch of the Russian Academy of Sciences

Email: mubarakshina@mail.ru
ORCID iD: 0000-0003-0207-7063

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

Russian Federation, Novosibirsk

Anna I. Chesnikova

Rostov State Medical University of the Ministry of Healthcare of Russia

Email: rostov-ossn@yandex.ru
ORCID iD: 0000-0002-9323-592X

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

Russian Federation, Rostov-on-Don

Larisa V. Rodionova

Pacific State Medical University of the Ministry of Healthcare of Russia

Email: mubarakshina@mail.ru

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

Russian Federation, Vladivostok

Elena S. Timoshchenko

City Clinical Hospital No. 5 of Nizhny Novgorod district

Email: timoshenko.gkdo@yandex.ru
ORCID iD: 0000-0003-2132-6467

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

Russian Federation, Nizhny Novgorod

Alexander N. Bykov

Sverdlovsk Regional Clinical Hospital No. 1

Email: mubarakshina@mail.ru
ORCID iD: 0000-0003-0787-7908

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

Russian Federation, Yekaterinburg

Andrey G. Obrezan

Saint Petersburg State University

Email: mubarakshina@mail.ru
ORCID iD: 0000-0001-6115-7923

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

Russian Federation, Saint Petersburg

Natalya V. Zakharchuk

Pacific State Medical University of the Ministry of Healthcare of Russia

Email: mubarakshina@mail.ru
ORCID iD: 0000-0002-5809-3989

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

Russian Federation, Vladivostok

Alexander V. Patrikeev

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia

Email: heartist@mail.ru
ORCID iD: 0000-0001-8657-4184
SPIN-code: 3439-4848

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

Russian Federation, Moscow

Ekaterina I. Tarlovskaya

Privolzhsky Research Medical University of the Ministry of Healthcare of Russia; City clinical hospital No. 38 of Nizhny Novgorod district

Email: mubarakshina@mail.ru
ORCID iD: 0000-0002-9659-7010

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

Russian Federation, Nizhny Novgorod; Nizhny Novgorod

Vera A. Nevzorova

Pacific State Medical University of the Ministry of Healthcare of Russia

Email: mubarakshina@mail.ru
ORCID iD: 0000-0002-0117-0349

MD, Dr. Sci. (Medicine), professor, director of the Institute of therapy and instrumental diagnostics

Russian Federation, Vladivostok

Svetlana A. Makarova

Nizhpharm JSC

Email: mubarakshina@mail.ru

MD, PhD (Medicine), head of the Group

Russian Federation, Nizhny Novgorod

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