LLC “SPC “PHARMASOFT” informed about completion of randomized, double-blind, multicenter, placebo-controlled in parallel groups study of effectiveness and safety of Mexidol in long-term sequential therapy in patients with hemispheric ischemic stroke EPICA in acute and early rehabilitation periods. The results of the study have been published (Stakhovskaya L.V., Shamalov N.A., Khasanova D.R., Melnikova E.V., et al. Journal of Neurology & Psychiatry named after S.S. Korsakov2017; 3 (2):55-65; Supplement “Stroke”).

Objective of the Research. To evaluate effectiveness and safety of long-term sequential therapy with preparation of Mexidol in patients with hemispheric ischemic stroke (IS) in acute and early rehabilitation periods.

Material and Methods. In a randomized, double-blind, multicenter, placebo-controlled study in parallel groups, 151 patients (62 men and 89 women) were enrolled, 150 patients (62 men and 88 women) aged 40 to 79 years were randomized. The patients were randomly assigned to 2 groups: patients of the 1st group received mexidol 500 mg/day by intravenously drop infusion for 10 days, followed by 1 tablet (125 mg) 3 times per day for 8 weeks. The patients of the 2nd group received a placebo according to similar scheme. The duration of participation in the study was 67 to 71 days.

Results. At the end of the therapy, the mean score by the modified Rankine scale (mSHR) was lower in the 1st group than in the 2nd one (p = 0.04). Dynamics of decrease in average score by mRS (1-5th visits) was more evident in the 1st group (p = 0.023). The proportion of patients, who achieved a recovery, corresponding to 0-2 points by mRS (5th visit) was significantly higher in the 1st group (p=0.039). When testing by Stroke Scale of National Institute of Health at the 5th visit, the mean value was lower in the 1st group (p=0.035). The decrease in score by Stroke Scale of National Institute of Health at the end of the course of the therapy relative to baseline in patients with diabetes mellitus was more pronounced in the 1st group (p=0.038).

In the 1st group, in general population of patients and subpopulation of patients with diabetes mellitus, the dynamics of improving quality of life was more evident and was observed since the 2nd visit.

Separate analysis of functions by EQ-5D questionnaire (health scale “movement”) in both treatment groups revealed a significant (p <0.001) linear dependence towards an increase in the number of patients with no problems with movement, as well as statistically significant difference between groups of the second and fifth visits. It was found that 53 (86.9%) patients of the 1st group noted that they had no problems with movement; 48 (78.7%) – noted that they had no problems with self-care; 43 (70.5%) – considered that they had no problems with everyday activities (work, study, household chores, family obligations, leisure activities); 52 (85.2%) – did not feel pain and discomfort; 54 (88.5%) – did not experience anxiety and depression.

In assessing safety, the tolerability of therapy with Mexidol and placebo is regarded as satisfactory. There were no significant differences in rate of adverse events in patients of both groups.

The obtained data indicate a comparable safety profile for preparation Mexidol^® and placebo, when used in patients in acute and early recovery periods of hemispheric IS.

Conclusion. It is recommended to include preparation Mexidol^® into the treatment of patients in acute and early recovery periods of ischemic stroke.

¹ Journal of Neurology & Psychiatry. 2017; 117: 3 (2): 55-65.

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