Efficacy of Mexidol in patients with chronic brain ischemia and cognitive impairment of different age groups (results of sub-analysis of the international multicenter, randomized, double-blind, placebo-controlled study of sequential therapy in patients with chronic brain ischemia MEMO)
Author:
V.V. ZAKHAROV1, O.N. TKACHEVA2,3, E.A. MKHITARYAN2,3, A.I. FEDIN2
1Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
2Pirogov Russian National Research Medical University , Moscow, Russia;
3Russian Clinical and Research Center of Gerontology, Pirogov Russian National Research Medical University , Moscow, Russia
Summary:
Objective. To assess the efficacy of sequential therapy with Mexidol and Mexidol FORTE 250 in comparison with placebo in patients of different age groups with chronic brain ischemia. Material and methods. The study is sub-analysis of data of the international multicenter, randomized, double-blind, placebo-controlled study of sequential therapy in patients with chronic brain ischemia (MEMO), which included 318 patients (25% men) in the age of 40—90 (median 60) years. All subjects were subdivided into 3 age subgroups: 40—60 years (n=163), 61—75 years (n=141) and 76—90 years (n=13). The primary efficacy endpoint was the dynamic of increase of total score by MoCA scale, i.e. the absolute value of difference by MoCA scale at the point of day 75 comparing to values before treatment. As secondary efficacy endpoints results of dynamic by following questionnaires and scales were used: digit symbol substitution test, the Health Survey SF-36, asthenia subjective assessment scale (MFI-20), Vane questionnaire, Beck anxiety scale, Tinetti scale. Results. After 75 days of treatment positive dynamic was revealed in cognitive, emotional and motor impairment in patients of 40—60 and 61—75 age subgroups both in groups of Mexidol and placebo, but in group of Mexidol the changes were more prominent which is proved by significantly higher values of median of absolute difference of total score of studied parameters. Conclusion. The results of trial showed that in patients of different age-subgroups with chronic brain ischemia the improvement in cognitive, motor impairment and quality of life, as well as decrease in vegetative impairment, asthenia and anxiety are observed after 75 days of treatment both in Mexidol and placebo group, but in Mexidol group these changes are more prominent. The data obtained confirm the expediency of the use of sequential therapy with Mexidol and Mexidol FORTE 250 in patients of different age subgroups with chronic brain ischemia. Keywords: cognitive impairment, chronic brain ischemia, Mexidol , Mexidol FORTE 250, ethylmethylhydroxypyridine succinate, MEMO trial.