Efficacy and safety of ethylmethylhydroxypyridine succinate in patients with ischemic stroke

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Author:

M.V. ZHURAVLEVA1,2, I.A. SHCHUKIN3, M.S. FIDLER3, A.B. PROKOFIEV2, S.YU. SEREBROVA2, N.S. VASYUKOVA4, E.YU. DEMCHENKOVA1, V.V. ARKHIPOV1,2
1Research Centre for Examination of Medical Devices, Moscow, Russia;
2Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
3Pirogov Russian National Research Medical University, Moscow, Russia;
4Federal Scientific Center — All-Russian Scientific Research Institute of Experimental Veterinary Medicine named after K.I. Skryabin and Ya.R. Kovalenko, Moscow, Russia

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Efficacy and safety of ethylmethylhydroxypyridine succinate in patients with ischemic stroke

Author:

M.V. ZHURAVLEVA1,2, I.A. SHCHUKIN3, M.S. FIDLER3, A.B. PROKOFIEV2, S.YU. SEREBROVA2, N.S. VASYUKOVA4, E.YU. DEMCHENKOVA1, V.V. ARKHIPOV1,2
1Research Centre for Examination of Medical Devices, Moscow, Russia;
2Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
3Pirogov Russian National Research Medical University, Moscow, Russia;
4Federal Scientific Center — All-Russian Scientific Research Institute of Experimental Veterinary Medicine named after K.I. Skryabin and Ya.R. Kovalenko, Moscow, Russia

Summary:
Stroke is still the most significant problem of the modern medicine and the leading cause of mortality and morbidity. There is the great experience of neuroprotection in patients with stroke in the Russian Federation. In clinical practice it’s important to follow conditions, where neuroprotection will have maximum safety and effectiveness. The clinical trials of ethylmethylhydroxypyridine succinate (mexidol) in patients with acute ischemic stroke are described in the present review. Early management (in the first 6 hours) with mexidol significantly improve recovery dynamic and stroke outcome. Therapy with mexidol increases neurological recovery, improves vital activity and quality of life of patients with stroke. Furthermore, mexidol demonstrates high safety profile. Keywords: ischemic stroke, thrombolytic therapy, clinical trial, disability, antioxidant system, ethylmethylhydroxypyridine succinate, Mexidol.


The efficacy of ethylmethylhydroxypyridine succinate in patients with cerebrovascular pathology complicated with diabetes mellitus and metabolic syndrome

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Author:

E.V. EKUSHEVA1,2, E.V. BIRYUKOVA3
1Academy of Postgraduate Education under the Federal State Budgetary Unit «Federal Scientific and Clinical Center for Specialized Medical Assistance and Medical Technologies of the Federal Medical Biological Agency», Moscow, Russia;
2Belgorod State National Research University, Belgorod, Russia;
3Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia

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The efficacy of ethylmethylhydroxypyridine succinate in patients with cerebrovascular pathology complicated with diabetes mellitus and metabolic syndrome

Author:
E.V. EKUSHEVA1,2, E.V. BIRYUKOVA3
1Academy of Postgraduate Education under the Federal State Budgetary Unit «Federal Scientific and Clinical Center for Specialized Medical Assistance and Medical Technologies of the Federal Medical Biological Agency», Moscow, Russia;
2Belgorod State National Research University, Belgorod, Russia;
3Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia

Summary:
Arterial hypertension, diabetes mellitus, obesity and dyslipidemia continue to be the main risk factors for diseases of the circulatory system and the leading causes of mortality in the world, the combination of these diseases significantly increases the likelihood of the development and more rapid progression of cardiovascular and cerebrovascular pathology. Improving approaches to the diagnosis and treatment of these diseases is a priority problem in modern medicine. Currently, there is no universal drug that can influence all stages of pathological process in both cerebrovascular diseases and diabetes mellitus, and the problem of rational use of drugs in patients with comorbid pathology has not been completely resolved. A difficult clinical task includes not only the timely detection of the disease and the correct diagnosis, but also the choice of the safest and most effective medicine. A number of clinical studies have demonstrated the efficacy of mexidol in the treatment of this category of patients, which is determined by its complex, pleiotropic and multimodal mechanisms of action. Keywords: cerebrovascular diseases, diabetes mellitus, metabolic syndrome, antioxidant therapy, mexidol.


Effectiveness and safety of mexidol forte 250 in the sequential therapy in patients with chronic ischemia

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Author:

N.G. KATAEVA1, T.A. ZAMOSHCHINA1,2, M.V. SVETLIK1,2
1 Siberian State Medical University , Tomsk, Russia;
2 National Research Tomsk State University , Tomsk, Russia

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Effectiveness and safety of mexidol forte 250 in the sequential therapy in patients with chronic ischemia

Author:
N.G. KATAEVA1, T.A. ZAMOSHCHINA1,2, M.V. SVETLIK1,2
1 Siberian State Medical University , Tomsk, Russia;
2 National Research Tomsk State University , Tomsk, Russia

Summary:
Objective. To study of efficacy and safety of mexidol used as intravenous infusion for 14 days, followed by per os treatment with mexidol FORTE 250 for 60 days in patients with chronic brain ischemia (CHM) complicated with arterial hypertension and atherosclerosis. Material and methods. The mexidol group included 27 patients (24 women and 3 men) with CHM I—II gr and the combination of arterial hypertension and atherosclerosis who received intravenous infusions of mexidol (500 mg once daily) within 14 days, with the subsequent per os treatment with mexidol FORTE 250 in a daily dose of 750 mg (1 tablet 3 times a day) for 60 days. The comparison group consisted of 30 patients (22 women and 8 men) with CHM I—II gr, comparable in age, nature of risk factors and expression of neurological manifestations. Patients in both groups received basic medications to treat their risk factors. Motor activity (Tinetti test), cognitive functions (MoCa test), anxiety and depression (Hamilton anxiety and depression scale), clinical condition (General Clinical Impression scale) were assessed. Results and conclusion. Inclusion of mexidol (500 mg iv infusion once a day within 14 days with the subsequent oral administration of 750 mg (1 tablet 3 times a day) for 60 days) in standard therapy of arterial hypertension with atherosclerosis and chronic brain ischemia is expedient. The results show greater clinical efficacy and sufficient safety of such combination therapy. By the end of therapy (day 74), patients in the mexidol group have a reliable improvement in motor activity, cognitive function and psychoemotional sphere, as well as a decrease in fatigue and neurological manifestations compared with the comparison group. Keywords: chronic ischemia of a brain, mexidol, mexidol FORTE 250.


The trial of the efficacy and safety of sequential therapy with mexidol forte 250 in acute and early recovery stages of hemispheric ischemic stroke

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Author:

M.A. LOSKUTNIKOV, M.A. DOMASHENKO, T.M. VAKIN, I.A. TRUSHINA, V.I. KONSTANTINOV, O.S. PROSKURYAKOVA, E.P. SHCHUKINA

Magnitogorsk Irong&Steel Clinical Hospital, Magnitogorsk, Russia

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The trial of the efficacy and safety of sequential therapy with mexidol forte 250 in acute and early recovery stages of hemispheric ischemic stroke

Author:

M.A. LOSKUTNIKOV, M.A. DOMASHENKO, T.M. VAKIN, I.A. TRUSHINA, V.I. KONSTANTINOV, O.S. PROSKURYAKOVA, E.P. SHCHUKINA

Magnitogorsk Irong&Steel Clinical Hospital, Magnitogorsk, Russia

Summary:
Objective. To evaluate the efficacy and safety of sequential therapy with mexidol (solution for intravenous and intramuscular injections) and mexidol forte 250 (coated tablets) in acute and early recovery stages of hemispheric ischemic stroke. Material and methods. The changes in scores on the modified Rankin Scale (mRs) (primary endpoint), the National Institute of Health Stroke Scale (NIHSS), the Bartel Index (BI), the Montreal Cognitive Assessment (MoCa), the Beck Depression Inventory (BDI), the EuroQol Quality of Lifes Scale ( EQ–5D) were assessed in the end of treatment (secondary endpoint). Results and Conclusion. Prolonged and sequential therapy with mexidol at the dose 500 mg daily during 14 days (saturation phase) and mexidol forte 250 at the dose of 250 mg three times a day during 60 days (maximum therapeutic effect) provides additional opportunities for a more complete recovery in acute and early recovery stages of hemispheric ischemic stroke (increases quality of life, improves movement and cognitive functions). Keywords: hemispheric ischemic stroke, mexidol forte 250, acute and early recovery stages, quality of life.


Efficacy and safety of Mexidol across age groups in the acute and early recovery stages of hemispheric ischemic stroke (results of additional sub-analysis of a randomized double blind multicenter placebo-controlled study, in parallel groups trial EPICA)

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Author:

L.V. STAKHOVSKAYA1, E.A. MKHITARYAN2, O.N. TKACHEVA1,2, T.M. OSTROUMOVA3, O.D. OSTROUMOVA3,4

1Pirogov Russian National Research Medical University, Moscow, Russia;
2Russian Clinical and Research Center of Gerontology of Pirogov Russian National Research Medical University, Moscow, Russia;
3Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical (Sechenov University),
Moscow, Russia;
4Russian Medical Academy of Continuous Professional Education, Moscow, Russia

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Efficacy and safety of Mexidol across age groups in the acute and early recovery stages of hemispheric ischemic stroke (results of additional sub-analysis of a randomized double blind multicenter placebo-controlled study, in parallel groups trial EPICA)

Author:

L.V. STAKHOVSKAYA1, E.A. MKHITARYAN2, O.N. TKACHEVA1,2, T.M. OSTROUMOVA3, O.D. OSTROUMOVA3,4

1Pirogov Russian National Research Medical University, Moscow, Russia;
2Russian Clinical and Research Center of Gerontology of Pirogov Russian National Research Medical University, Moscow, Russia;
3Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical (Sechenov University),
Moscow, Russia;
4Russian Medical Academy of Continuous Professional Education, Moscow, Russia

Summary:
Aim. To evaluate the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (IS) across age groups according to the World Health Organization classification. Material and methods. The study is an additional analysis across age groups among patients participated in the randomized double blind multicenter placebo-controlled, in parallel groups trial EPICA. All subjects (62 men and 88 women) were subdivided into age groups: younger than 60 years, 60—65 years, 76—90 years. Additionally, all participants were divided into 2 populations: ITT (Intent to treat population, patients who received at least one treatment/placebo dose) and PP (Per protocol population, patients who received treatment per study protocol). Results of Modified Rankin scale (mRs) at the end of treatment period, Barthel index, Beck depression inventory, European Quality of Life Questionnaire were assessed. Results. The efficacy of mexidol assessed with all the scales did not differ depending on the age group. By the end of treatment, the mean mRS score was lower in the 76-90 years subgroup (in both populations), compared to placebo (p<0,001). The decrease in mean mRS score (Visit 1—5) was more prominent in patients aged 60—65 years (p=0,025), including patients with diabetes mellitus (DM). Patients aged 76—90 years and patients with DM, compared to placebo, had a decrease of the severity of cognitive-affective depression symptoms (p=0,049 and p=0,02) and an increase in patients without problems with everyday activities (p=0,007 and p=0,02). Patients with DM, compared to placebo, also had the higher levels of everyday activity (p=0,023) and quality of life (p=0,045). There were no statistically significant differences in the frequency of side-effects in patients of all groups. Conclusion. It is recommended to include mexidol in therapy of patients with IS in the acute and early rehabilitation stages in all age groups, including patients with DM. Keywords: ischemic stroke, mexidol, ethylmethylhydroxypyridine succinate, efficacy and safety, ischemic stroke, acute period, acute rehabilitation period, EPICA.