Results of a Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Mexidol in Prolonged Sequential Therapy of Patients in the Acute and Early Recovery Stages of Hemispheric Stroke (the EPICA study)
Author:
L. V. Stakhovskaya1, N. A. Shamalov1, D. R. Khasanova2, E. V. Mel’nikova3, A. S. Agaf’ina4, K. V. Golikov5, E. I. Bogdanov6, A. A. Yakupova6, L. V. Roshkovskaya7, L. V. Lukinykh8, T. M. Lokshtanova9, I. E. Poverennova10, and L. A. Shchepankevich11
1 Research Institute of Cerebrovascular Pathology and Stroke, Pirogov Russian National Research Medical University, Russian Ministry of Health, Moscow, Russia; e-mail: lstakh@mail.ru.
2 Interregional Clinical Diagnostic Center, Kazan, Russia.
3 St. Petersburg City Clinical Hospital No. 26, St. Petersburg, Russia.
4 St. Petersburg City Clinical Hospital No. 40 of the Resort Administrative District, St. Petersburg, Russia.
5 St. Petersburg City General Hospital No. 2, St. Petersburg, Russia.
6 Kazan Sate Medical University, Russian Ministry of Health, Kazan, Russia.
7 Nikolaevskaya Hospital, St. Petersburg, Russia.
8 Vsevolzhsk Clinical Interregional Hospital, Leningradskaya Oblast, Russia.
9 Pirogov City Clinical Hospital No. 1, Samara, Russia.
10 Seredavin Samara Regional Clinical Hospital, Samara, Russia.
11 Research Institute of Experimental and Clinical Medicine, Novosibirsk, Russia.
Summary:
Objectives. To assess the effi cacy and safety of prolonged sequential therapy with Mexidol in patients with hemispheric ischemic stroke (IS) in the acute and early recovery phases. Materials and methods. A randomized, double-blind, multicenter, placebo-controlled, parallel-group study included 151 patients (62 men and 89 women) was performed in which 150 patients (62 men and 88 women) aged 40–79 years were randomized. Simple randomization was used to defi ne two groups: patients of group 1 received Mexidol therapy at a dose of 500 mg/day by intravenous infusion for 10 days followed by oral doses of 1 tablet (125 mg) three times a day for eight weeks. Patients of group 2 received placebo by the same protocol. The duration of involvement in the trial was 67–71 days. Results. At the end of treatment, mean scores on the modified Rankin scale (mRS) were lower in group 1 than group 2 (p = 0.04). Decreases in mean mRS scores (at visits 1–5) were more marked in group 1 (p = 0.023). The proportion of patients achieving recovery corresponding to 0–2 points on the mRS (at visit 5) was signifi cantly greater in group 1 (p = 0.039). Testing on the National Institutes of Health Stroke Scale at visit 5 gave a signifi cantly lower score in group 1 (p = 0.035). Decreases in scores on the National Institutes of Health Stroke Scale at the end of treatment relative to the baseline level in patients with diabetes mellitus were more marked in group 1 (p = 0.038). In group 1, the total population and the subpopulation of patients with diabetes mellitus showed more marked improvements in quality of life, which was apparent by visit 2. The proportion of patients without diffi culty mobilizing was signifi cantly greater in group 1 (p = 0.022). There were no signifi cant differences in the frequencies of adverse events in patients of the two groups. Conclusions. Use of Mexidol in the acute and early recovery phases of IS is recommended. Keywords: acute cerebrovascular accident, Mexidol, ethylmethylhydroxypyridine succinate, effi cacy and safety, ischemic stroke, acute phase, early recovery phase, EPICA.