The results of a randomized double blind multicenter placebo-controlled in parallel groups of the study and safety of Mexidol with prolonged consistent therapy in patients in acute and early restorations. Periods

Authors:
L.V. STAKHOVSKAYA¹, N.A. SHAMALOV¹, D.R. KHASANOVA², E.V. MELNIKOVA³, A.S. AGAFINA⁴, K.V. GOLIKOV⁵, E.I. BOGDANOV⁶, A.A. YAKUPOVA⁶, L.V. ROSHKOVSKA⁷, L.V. LUKINYKH⁸, T.M. LOKSHTANOVA⁹, I.E. Poverennova¹⁰, L.A. SCHEPANKEVICH¹¹

¹Research Institute of Cerebrovascular Pathology and Stroke, Pirogov Russian National Research Medical University, Moscow, Russia;
²Interregional Clinical and Diagnostic Center, Kazan, Russia;
³St. Petersburg City Hospital No. 26, St. Petersburg, Russia;
⁴St. Petersburg City Hospital No. 40 of the Kurortny Administrative District, St. Petersburg, Russia;
⁵St. Petersburg City Multidisciplinary Hospital No. 2, St. Petersburg, Russia;
⁶Kazan State Medical University, Kazan, Russia;
⁷St. Petersburg Nikolaevskaya Hospital, St. Petersburg, Russia;
⁸Vsevolozhsk Clinical Interdistrict Hospital, Leningrad Region, Russia.
⁹MUBZ City Clinical Hospital No. 1 named after N.I. Pirogov, Samara, Russia;
¹⁰State Budgetary Healthcare Institution Samara Regional Clinical Hospital named after V.D. Seredavin, Samara, Russia;
¹¹Federal State Budgetary Scientific Institution Research Institute of Experimental and Clinical Medicine, Novosibirsk, Russia.

Place of publication:
JOURNAL OF NEUROLOGY AND PSYCHIATRY, 3, 2017; ISSUE 2

Abstract:
Objective of the study. To evaluate the efficacy and safety of long-term sequential therapy with Mexidol in patients with hemispheric ischemic stroke (IS) in the acute and early recovery periods. Material and methods. The randomized, double-blind, multicenter, placebo-controlled, parallel-group study included 151 patients (62 men and 89 women), 150 patients (62 men and 88 women) aged 40 to 79 years were randomized. Patients were divided into 2 groups by simple randomization: patients in group 1 received Mexidol therapy at 500 mg / day intravenously by drip for 10 days, followed by taking 1 tablet (125 mg) 3 times a day for 8 weeks. Patients in group 2 received placebo according to a similar regimen. The duration of participation in the study ranged from 67 to 71 days. Results. At the end of therapy, the mean modified Rankin Scale (mRS) score was lower in group 1 than in group 2 (p=0.04). The decrease in the mean mRS score (visits 1–5) was more pronounced in group 1 (p=0.023). The proportion of patients who achieved recovery corresponding to 0–2 points on the mRS (visit 5) was significantly higher in group 1 (p=0.039). When testing on the National Institutes of Health Stroke Scale at visit 5, the mean value was lower in group 1 (p=0.035). The decrease in the National Institutes of Health Stroke Scale score at the end of therapy relative to the baseline level in patients with diabetes mellitus was more pronounced in group 1 (p=0.038). In Group 1, both the general patient population and the diabetic subpopulation showed more pronounced improvements in quality of life, beginning with Visit 2. The proportion of patients without mobility issues was significantly higher in Group 1 (p=0.022). No significant differences in the incidence of adverse events were found between the two groups. Conclusion: The use of Mexidol is recommended in the acute and early recovery periods of ischemic stroke.