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)
Objectives. To assess the efficacy 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 define 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 significantly greater in group 1 (p = 0.039). Testing on the National Institutes of Health Stroke Scale at visit 5 gave a significantly 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 difficulty mobilizing was significantly greater in group 1 (p = 0.022). There were no significant 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.
Keywordsacute cerebrovascular accident Mexidol ethylmethylhydroxypyridine succinate efficacy and safety ischemic stroke acute phase early recovery phase EPICA
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- 1.E. I. Gusev, V. I. Skvortsova, and L. V. Stakhovskaya, “The epidemiology of stroke in Russia,” Zh. Nevrol. Psikhiatr. im. S. S. Korsakova, 103, No. 8, 4–9 (2003).Google Scholar
- 2.E. I. Gusev and V. I. Skvortsova, “Neuroprotective treatment of ischemic stroke. I. Primary neuroprotection,” Zh. Nevrol. Psikhiatr. im. S. S. Korsakova, 102, No. 5, 3–7 (2002).Google Scholar
- 3.L. B. Novikova, L. R. Sharafutdinova, and K. M. Sharapova, “The use of Mexidol in the acute period of ischemic stroke,” Zh. Nevrol. Psikhiatr. im. S. S. Korsakova, 113, No. 9, Iss. 1, 83–85 (2013).Google Scholar
- 5.L. V. Stakhovskaya and S. V. Kotova, Stroke, Guidelines for Doctors, Medical Information Agency, Moscow (2013).Google Scholar
- 6.O. A. Gromova, I. Yu. Torshin, I. S. Sardaryan, L. E. Fedotova, and V. A. Semenov, “A comparative chemoreactome analysis of Mexidol,” Farmakokin. Farmakodin., 4, 19–30 (2016).Google Scholar
- 7.V. I. Skvortsova, L. V. Stakhovskaya, Ya. R. Nartsissov, M. K. Bodykhov, I. V. Kichuk, Yu. V. Gudkova, T. D. Soldatenkova, T. T. Kondrasheva, E. V. Kalinina, M. D. Novichkova, and O. B. Kerbikov, “A randomized, double-blind, placebo-controlled study of the efficacy and safety of Mexidol in the complex treatment of ischemic stroke in the acute phase,” Zh. Nevrol. Psikhiatr. im. S. S. Korsakova, 106, No. 18, 47–54 (2006).Google Scholar
- 8.E. I. Chukanova, A. S. Chukanova, and Kh. I. Mamaeva, “Results of a study of the efficacy and safety of Mexidol in patients with chronic cerebral ischemia,” Zh. Nevrol. Psikhiatr. im. S. S. Korsakova, 115, No. 2, Iss. 1, 71–74 (2015).Google Scholar
- 10.V. V. Koval’chuk, “Effects of Mexidol on neurological deficit, social and daily adaptation, and neglect and ‘repulsion’ syndrome in poststroke patients,” Zh. Nevrol. Psikhiatr. im. S. S. Korsakova, 111, 12, No. 2, 52–57 (2011).Google Scholar
- 11.L. A. Shevchenko, R. V. Krivosheev, and V. A. Evdokimov, “On the question of the therapeutic efficacy of using Mexidol in the complex treatment of patients with cerebral stroke,” Mezhdun. Nevrol. Zh., 2, No. 6, 88–92 (2006).Google Scholar
- 12.T. A. Voronina, The Russian New-Generation Drug Mexidol: Main Effects, Mechanism of Action, and Use. Methodological Guidelines, Research Institute of Pharmacology, Russian Academy of Medical Sciences (2003).Google Scholar
- 13.B. A. Spasennikov, “The use of Mexidol in the treatment of cerebral stroke,” Med. Nauki, 58, 1–16 (2017).Google Scholar
- 14.S. M. Kuznetsova, V. V. Kuznetsov, and F. V. Yurchenko, “Mexidol in the rehabilitation of elderly patients with ischemic stroke,” Farmateka, 15, 105–108 (2009).Google Scholar