International multicenter randomized double-blind placebo-controlled study assessing the efficacy and safety of sequential therapy with Mexidol® and Mexidol® FORTE 250 in patients with chronic brain ischemia (memo): subanalysis in patients with arterial hypertension
- Authors: Zakharov V.V.1, Ostroumova O.D.1,2, Kochetkov A.I.2, Klepikova M.V.2, Fedin A.I.3
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Affiliations:
- I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University)
- Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia
- N.I. Pirogov Russian National Research Medical University of the Ministry of Healthcare of Russia
- Issue: Vol 9, No 1 (2023)
- Pages: 145-159
- Section: ACTUAL ISSUES OF PHARMACOTHERAPY AND PREVENTIVE TREATMENT
- URL: https://journals.eco-vector.com/2412-4036/article/view/321990
- DOI: https://doi.org/10.18565/therapy.2023.1.145–159
- ID: 321990
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Abstract
Chronic brain ischemia (CBI) is one of the most common neurological disorders in clinical practice.
Objective: to evaluate the efficacy and safety of sequential therapy with Mexidol® solution intravenously and Mexidol® FORTE 250 film-coated tablets, 250 mg orally in patients with and without arterial hypertension (AH) in terms of the drug effect on cognitive functioning, as well as the severity of asthenic, anxiety, vegetative and motor disorders, and quality of life in CBI.
Material and methods. In a subanalysis patients with CBI were divided into four subgroups: 1st – AH patients receiving Mexidol® and Mexidol® FORTE 250 (n=144); 2nd – AH patients receiving placebo (n=146); 3rd – patients without AH receiving Mexidol® and Mexidol® FORTE 250 (n=15); 4th – patients without AH receiving placebo (n=12).
Results. At the end of the follow-up, significant differences were found in the dynamics of the MoCA scores between the patients receiving Mexidol® and placebo (p=0,000), which allows to state a superior efficacy of Mexidol in the subgroup of patients with AH. Also in the long-term sequential therapy with Mexidol®, in contrast to the placebo, the median value of the MoCA score at the end of the follow-up reached normal levels in patients with and without AH. When assessing secondary efficacy endpoints, a significant advantage of Mexidol® over placebo in the population of patients with AH at the end of follow-up was achieved on the following parameters: The Digit Symbol Substitution Test, MFI-20, the Beck Anxiety Inventory, Tinetti Performance-Oriented Mobility Assessment, psychological component of health according to SF-36 questionnaire. A comparable character of the safety profile of Mexidol® and placebo was established.
Conclusion. The obtained results allow to recommend the use of long-term sequential therapy with Mexidol in the complex therapy of patients with AH and CBI as a tool for the brain protection as a AH target organ and as a tool of pathogenetically substantiated therapy of cognitive, emotional, asthenic, vegetative and motor disorders.
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About the authors
Vladimir V. Zakharov
I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University)
Author for correspondence.
Email: zakharovenator@gmail.com
ORCID iD: 0000-0002-8447-3264
MD, professor of the Department of nervous diseases and neurosurgery
Russian Federation, MoscowOlga D. Ostroumova
I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University); Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia
Email: ostroumova.olga@mail.ru
ORCID iD: 0000-0002-0795-8225
SPIN-code: 3910-6585
MD, professor, head of the Department of therapy and polymorbid pathology named after academician M.S. Vovsi, professor of the Department of clinical pharmacology and propaedeutics of internal diseases
Russian Federation, Moscow; 125993, Moscow, 2/1 Barrikadnaya Str., bldg. 1Alexey I. Kochetkov
Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia
Email: ak_info@list.ru
ORCID iD: 0000-0001-5801-3742
SPIN-code: 9212-6010
PhD in Medical Sciences, associate professor, associate professor of the Department of therapy and polymorbid pathology named after academician M.S. Vovsi
Russian Federation, 125993, Moscow, 2/1 Barrikadnaya Str., bldg. 1Maria V. Klepikova
Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia
Email: pelageam@yandex.ru
ORCID iD: 0000-0003-4258-1889
PhD in Medical Sciences, associate professor of the Department of therapy and polymorbid pathology named after academician M.S. Vovsi
Russian Federation, 125993, Moscow, 2/1 Barrikadnaya Str., bldg. 1Anatoly I. Fedin
N.I. Pirogov Russian National Research Medical University of the Ministry of Healthcare of Russia
Email: fedin.anatoly@gmail.com
ORCID iD: 0000-0002-6996-2828
MD, professor, professor of the Department of neurology of the Faculty of additional professional education, Honored Doctor of the Russian Federation
Russian Federation, 117997, Moscow, 1 Ostrovityanova Str.References
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