International multicenteric randomized double-tied placebo-controlled study of evaluating the effectiveness and safety of sequential therapy of patients with chronic brain ischemia drugs Mexidol® and Mexidol® Forte 250 (study of memo): Subanalysis results in patients with arterial hypertension

V.V. ZAKHAROV¹, O.D. OSTROUMOVA^1,2, A.I. KOCHETKOV², M.V. KLEPIKOVA², A.I. FEDIN³

¹Federal State Autonomous Educational Institution of Higher Education “I.M. Sechenov First Moscow State Medical University” of the Russian Ministry of Health (Sechenov University);
²Federal State Budgetary Educational Institution of Higher Professional Education “Russian Medical Academy of Continuous Professional Education” of the Russian Ministry of Health, Moscow;
³Federal State Autonomous Educational Institution of Higher Education “N.I. Pirogov Russian National Research Medical University” of the Russian Ministry of Health, Moscow

Place of publication:
THERAPY No. 1 (63) 2023

Abstract:
Abstract. Chronic cerebral ischemia (CCI) is one of the most common neurological pathological conditions in clinical practice. Objective : to evaluate the efficacy and safety of sequential therapy with^® intravenous^® FORTE 250 in groups of patients with and without arterial hypertension (AH) in terms of the drug effect on cognitive functioning, as well as the severity of asthenic, anxiety, autonomic and motor disorders and quality of life in CCI. Material and Methods. In the subanalysis, patients with CCI were divided into 4 subgroups: 1st - patients with AH who received Mexidol^® and Mexidol^® FORTE 250 (n=144); 2nd - patients with AH who received placebo (n=146). 3rd – patients without hypertension who received Mexidol^® and Mexidol^® FORTE 250 (n=15); 4th – patients without hypertension who received placebo (n=12). Results. At the end of the observation period, statistically significant differences in the dynamics of scores on the MoCA scale were revealed between the groups of patients receiving Mexidol^® and placebo (p=0.000), indicating the superior efficacy of Mexidol in the subgroup of patients with hypertension. Against the background of therapy with Mexidol^®, in contrast to placebo, the median value of the score on the MoCA scale at the end of the observation period reached the normal level in all patients. When assessing the secondary efficacy endpoints, a statistically significant advantage of Mexidol over placebo in the population of patients with hypertension at the final visit was achieved for the following parameters: digit symbol substitution test, MFI-20 asthenia rating scale, Beck anxiety inventory, Tinetti scale, psychological health component according to the SF-36 questionnaire. A comparable safety profile of Mexidol and placebo was established. Conclusion. The obtained results provide grounds to recommend long-term sequential use of Mexidol^® in the complex treatment of patients with hypertension and chronic cerebral ischemia as a tool for protecting the brain as a target organ of hypertension and a means of pathogenetically substantiated therapy of cognitive, emotional, asthenic, autonomic and movement disorders. Key words: chronic cerebral ischemia, arterial hypertension, cognitive impairment, ethyl methylhydroxypyridine succinate, Mexidol^®, Mexidol^® FORTE 250.