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

Author:
ZAKHAROV V.V.¹, OSTROUMOVA O.D.^1,2, KOCHETKOV A.^1,2, KLEPIKOVA M.V.², FEDIN A.^1,3

¹I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of Russia (Sechenov University)
²Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russia, Moscow
³N.I. Pirogov Russian National Research Medical University of the Ministry of Healthcare of Russia, Moscow

Summary:
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. Key words: chronic brain ischemia, arterial hypertension, cognitive impairment, ethylmethyhydroxypyridine succinate, Mexidol^®, Mexidol^® FORTE 250.