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Evidence base

To the question of the evidence base of neuroprotective therapy: Focus on ethylmethylhydroxypyridine succinate

Authors:
A.I. Kochetkov, N.A. Shatalova, M.V. Klepikova, T.V. Filippova, O.D. Ostroumova
FSBEI DPO “Russian Medical Academy of Continuing Professional Education” of the Ministry of Health of Russia, Moscow

Place of publication:
therapy No. 8 (70) 2023

Summary:
Annotation. Chronic brain ischemia (Khim) is one of the most common neurological pathologies. Its development is affected by many factors, among which arterial hypertension (AH) occupies a special place. Him contributes to cognitive impairment, negatively affects the quality of life and leads to motor and psycho -emotional disorders. In the aspect of the therapy of this condition, an important role belongs to neuroprotectors and, in particular, the use of ethylmethylhydroxypyridine of succinate (Mexol ® , NPK Pharmasoft LLC, Russia), which has a multimodal effect and confirms its high efficiency in a large number of clinical studies. The evidence base of ethylmethylhydroxypyridine of the succinate, including in the study of Memo, indicates the particularly high effectiveness of the drug among patients with Khim and AG: they have Mexol ® significantly improves cognitive functions, reduces the level of anxiety and asthenia and improves the quality of life. With this in mind, the drug can be recommended for use in complex therapy of chemicals, especially in patients with AG. Keywords: chronic brain ischemia, ethylmethylhydroxypyridine succinate, Mexidol ® , arterial hypertension, cognitive functions.

International multicenteric randomized double-tied placebo-controlled study of evaluating the effectiveness and safety of sequential therapy of patients with chronic brain ischemia drugs Mexidol® and Mexidol® Forte 250 (study of memo): Subanalysis results in patients with arterial hypertension

Authors:
V.V. Zakharov 1 , O.D. Ostroumova 1.2 , A.I. Kochetkov 2 , M.V. Klepikov 2 , A.I. Fedin 3

1 FGAOU VO "First Moscow State Medical University named after THEM. Sechenov »Ministry of Health of Russia (Sechenov University);
2 FSBEI of DPO “Russian Medical Academy of Continuing Professional Education” of the Ministry of Health of Russia, Moscow;
3 FGAOU in Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow

Place of publication:
therapy No. 1 (63) 2023

Summary:
Annotation. Chronic brain ischemia (Khim) is one of the most common in the clinical practice of neurological pathological conditions. The goal is to evaluate the effectiveness and safety of sequential therapy with Mexidol ® intravenously and Mexidol ® Fort 250 oral in groups of patients with arterial hypertension (AH) and without the aspect of the drug on cognitive functioning, as well as the severity of asthenic, anxiety, autonomic and motor disorders, and Quality of life in a chemical conditions. Material and methods. Within the framework of subanalysis, patients with chemicals were divided into 4 subgroups: 1st-patients with AH who received drugs Mexidol ® and Mexidol ® Forter 250 (n = 144); 2nd-patients with AG who received placebo (n = 146); 3rd-patients without hypertension receiving Mexidol ® and Mexol ® Fort 250 (n = 15); 4th-patients without hypertension receiving placebo (n = 12). Results. At the end of the observation period, statistically significant differences in the dynamics of the Mosa scale between groups of patients receiving Mexidol ® and placebo (p = 0,000), indicating the superior effectiveness of the use of Mexidol in the subgroup of patients with AH, were identified. Against the background of therapy with Mexidol ® , unlike placebo, the median value of the point on the Mosa scale at the end of the observation period reached the level of norm in all patients. When assessing the secondary endpoints of effectiveness, the statistically significant advantage of Mexidol over the placebo in the population of patients with AH at the final visit was achieved by the following parameters: a test of digital characters, an asthenication scale MFI-20, a Bek anxiety scale, a tinetti scale, and a psychological component of health according to the questionnaire according to the questionnaire SF-36. The comparable nature of the safety profile of Mexidol and placebo is established. Conclusion. The results give reason to recommend the long-term consistent use of the drug Mexidol ® in the complex treatment of patients with hypertension as an instrument for protecting the brain as an organ-canal and means of pathogenetically substantiated therapy of cognitive, emotional, asthenic, vegetative and motor disorders. Keywords: chronic brain ischemia, arterial hypertension, cognitive disorders, ethylmethydroxypirinate, Mexidol ® , Mexidol ® Fort 250.

The results of a multicenter dual blind randomized placebo-controlled clinical study on the assessment of the effectiveness and safety of the drug Mexidol in the treatment of attention deficit syndrome in children (mega)

Authors:
N.N. Zavadenko 1 , N.Yu. Suvorinova 1 , T.T. Batysheva 2 , O.V. Bykova 2 , A.N. Platonova 2 , D.D. Gainetdinova 3 , E.V. Levitina 4 , V.V. Machines 5 , I.N. Vakula 6 , N.E. Maksimova 7

1 FGAOU in Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia;
2 GBUZ "Scientific and practical center of children's psychoneurology of the Department of Health of Moscow", Moscow, Russia;
3 FSBEI in Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia;
4 FSBEI in Tyumen State Medical University of the Ministry of Health of Russia, Tyumen, Russia;
5 FSBEI in Ulyanovsk State University, Ulyanovsk, Russia;
6 LLC "Center for Professional Therapy", Krasnodar, Russia;
7 FSBEI in the Tver State Medical University, Tver, Russia

Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2022, T.122, No. 4

Summary:
Purpose of the study. Evaluate the effectiveness and safety of two dosing modes of the drug Mexidol tablets covered with a film shell, 125 mg (NPK Farmasoft LLC, Russia), compared with placebo, in children with attention deficit (ADHD) from 6 to 12 years. Material and methods. The study was carried out in 14 clinical centers of the Russian Federation as a multicenter randomized double-blind, placbo-controlled double-controlled in 3 parallel groups. The study was attended by 333 children aged 6 to 12 years with a confirmed diagnosis of ADHD, established in accordance with the criteria of the ICD-10 and DSM-5. After screening (up to 14 days), patients were randomized in 3 groups in a ratio of 1: 1: 1: Mexidol 125 mg 2 times a day, Mexidol 125 mg 1 time per day+placebo and placebo. The duration of treatment in all groups was 42 days. The study was completed by 332 children. The dynamics of the state was evaluated by the scales of the ADHD assessment and related disorders. Results. Statistically significant changes in the amount of the total score on the subx “Inattentiveness”, “Hyperactivity impulsivity” of the ADHG assessment scale through 6 weeks of therapy in all three groups of the study (P <0.05). At the same time, between the groups of Mexol 125 mg 1 time per day+placebo and placebo, as well as between Mexol groups 125 mg 2 times a day and placebo, expressed statistically significant differences were observed (for the PP: P = 0.000308 and P = 0.000024 Accordingly, for the population FAS: P = 0.000198 and P = 0.000024, respectively), which indicates the superiority of the therapy with Mexidol. According to most secondary criteria for effectiveness (average changes in points on the “Inattention” Snap-IV scale, the average change in scores “Hyperactivity impulsiveness” of the SNAP-IV scale, the average change in the cones index of the SNAP-IV scale, the average change in the value On the ADHD Rating Scale IV scale, assessments on the scale of the general clinical impression of the severity of ADHD, estimates on the general clinical impression scale - improvement) were also obtained statistically significant differences (p <0.05) when comparing the treatment of Mexido with placebo. The results of a statistical analysis of the frequency of the occurrence of undesirable phenomena, indicators of laboratory tests, and a physically examination demonstrate the absence of significant differences between compared groups in basic safety indicators. Conclusion. The treatment regimen with Mexol, tablets covered with a film shell, 125 mg 2 times a day, showed an advantage over Mexol's scheme tablets covered with a film shell, 125 mg once a day+placebo. A comparable nature of the security profiles of the studied dosing of the drug Mexidol and placebo was obtained. Keywords: attention deficit syndrome with hyperactivity, inattention, hyperactivity, impulsiveness, children, pharmacotherapy, ethylmethydlhydroxypyridine succinate, Mexidol.

Promising Effects of Emoxypine and Its Succinate Derivate in the Management of Various Disess-Withs on Recent Patent Applications

Authors:

Dhruv Sanjay Gupta, Siddhi Bagwe Parab, Ginpreet Kaur

Translated from Zhurnal Nevrologi I Psikhiatrii Imeni SS Korsakova, Vol. 121, no. 12, ISS. 2, pp. 69–76,
December 2021. Original Article Submitted December 20, 2021. Accepted December 22, 2021.

Place of publication:
Neuroscience and Behavioral Physiology, Vol. 52, no. 5, June, 2022

Summary: Emoxypine and Its Succinate Derivative Share a Common Hydroxypridine Structure, Which Is to Pyridoxine. Thus compounds have been Utilized therapeutically and industrially, Owing to the Wide Range of Properties Offorded. This Includes Antihypoxic, Neuroprotective and Cardioprotective Effects, Along with Pharmacokinetic Benefits Such as the Blood Brain Brain Brain, O Wing to Its Relatively Small Size and Low Molecular Weight. IT Was Observed that Emoxypine Exhibited Iron Chelating Property in Vitro, Indicating Its Usage as a Promising Therapeutic Strategy in the Management of Neurodegenerate ONS SUCH ALZheimer's Disease (Ad), As Well as Hematologic Disorders Like Thalassemia and Hemochromatosis. In Addition to this, it has been Observed to Exert Antioxidant Effect, TheFore, It May BE Considered for the Amelioration of Disoraders Resulting From Free Radical Injury. Studies on Its Mechanism of Action and Implications on Cellular and Molecular Levels Would Help To Further The Understanding of Its Benefits, AS Soles Proospects for For Novel Applications. The Primary Focus of this Review is to dress on the Broad SPACTRUMACOLOGICAL Properties Offered BY Emoxypine and Its Succinate Derivative, and To HIGHHLIGHT THE Cope for An Increased Number of Pre-Clinical and Clinical Trite Assess Its Safety and Efficacy. In Addition to this, The Highlights of this Article Include the Recent Patents Field and Scope for Novel Applications of these Agents.  Keywords: NeuroinflamMation, Mitochondrial Dysfunction, Iron Overload, Mexidol, Acute Kidney Injury, Cerebrooprotection

The results of an international multicenter randomized double-blind-controlled study of evaluating the effectiveness of the effectiveness and safety of consistent therapy of patients with chronic brain ischemia with Mexidol and Mexidol Forte 250 (study of Memo)

Authors:
A.I. Fedin 1 , V.V. Zakharov 2 , M.M. Tanashian 3 , E.I. Chukanova 1 , E.N. Majidova 4 , L.A. Shchepankevich 5.6 , O.D. Ostroumova 7

1 FGAOU in Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia;
2 FGAOU VO "First Moscow Medical University named after THEM. Sechenov »Ministry of Health of Russia (Sechenov University), Moscow, Russia;
3 FGBNU "Scientific Center for Neurology", Moscow, Russia;
4 Tashkent Pediatric Medical Institute of the Ministry of Health of the Republic of Uzbekistan, Tashkent, the Republic of Uzbekistan;
5 FSBEI in Novosibirsk State Medical University of the Ministry of Health of Russia, Novosibirsk, Russia;
6 FGBNU "Federal Research Center for Fundamental and Transalized Medicine", Novosibirsk, Russia;
7 FSBEA DPO “Russian Medical Academy of Continuing Professional Education” of the Ministry of Health of Russia, Moscow, Russia

Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2021, T.121, No. 11

Summary:
Purpose of the study. To evaluate the effectiveness and safety of consistent therapy with the drug Mexidol intravenously and Mexidol Forte 250 orally in patients with chronic brain ischemia.

Material and methods. In the international multicenteric randomized double-blind-controlled study, 318 patients with a chemical place from 40 to 90 years are included in 15 clinical centers, located in the territory of the Russian Federation and the Republic of Uzbekistan. Patients were randomized in 2 groups, patients of the 1st group received Mexidol intravenously 500 mg once a day for 14 days, then Mexidol Forte 250 was prescribed orally 250 mg 3 times a day for the next 60 days; Patients of the 2nd group received placebo in a similar mode. As the primary criterion for effectiveness, the average value of the change in the point on the MOCA scale was chosen at the stage of completion of the study by the patient compared to the initial level.

Results. Upon completion of the study between the 1st and 2nd groups, reliable differences were identified by the result of the MOCA scale (p <0.000001). The lower boundary of 95% of the trust interval for the difference in the average indicators of the main criterion for the effectiveness between the 1st and 2nd groups was 1.51, which allows the higher efficiency of the use of Mexidol. According to the secondary endpoints, a statistically significant advantage over the placebo at the final visit was achieved by the following parameters: a test of digital symbol replacements, an asthenia assessment scale, a Bek anxiety scale, a tineta questionnaire, a Tinetti scale, a SF-36 questionnaire (psychological component of health), and a psychological component of health). CGI scale (a general clinical impression scale). The comparable nature of the safety profile of Mexidol and placebo is established.

Conclusion. The validity and expediency of the consistent use of Mexidol and Mexidol Forte 250 in the treatment of patients with chemicals are demonstrated.

Keywords: chronic brain ischemia, cognitive disorders, neuropsychological testing, ethylmethylhydroxypyrididine succinate, Mexidol, Mexidol Forte 250, treatment of chemicals, examination of memes.

Original and reproduced drugs: what do the clinician need to know?

Author:
A.V. Schulkin, A.A. Filimonova
FSBEI in the Ryazan State Medical University of the Ministry of Health of Russia, Ryazan, Russia

Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2021, T. 121, No. 10, Issue. 2

Summary:
in a review article, modern approaches to testing and registration of reproduced (generic) drugs are considered. The history of the formation of a methodology for research of reproduced drugs and modern legislation of the Russian Federation is presented. The stages of confirmation of the equivalence of original and reproduced drugs are described: pharmaceutical equivalence, bioequivalence and therapeutic equivalence. Methods of evaluating bioequivalence as a basic study in the registration of reproduced drugs are analyzed in detail. On the example of the original domestic neuroprotector of the drug Mexidol (ethylmethylhydroxypyrididine of succinate) and its generiks described how legislative acts are implemented in practice. It is concluded that not all reproduced drugs can be interchangeable with the original drug.

Keywords: original and reproduced drugs, generics, ethylmethylhydroxypyridine succinate, Mexidol.

Reproduced drugs: Benefit ratio/risk

Authors:
E.A. Ushkalova 1 , S.K. Zyryanov 1.2 , I.A. Gopienko 1
1 FGAOU in Russian University of Friendship of Peoples, Moscow;
2 GBUZ in Moscow "City Clinical Hospital No. 24 of the Department of Health of the city of Moscow", Moscow

Place of publication:
neurology, neuropsychiatry, psychosomatics. 2021; 13 (6)

Summary:
The review discusses the interchangeability of drugs (drugs), approaches to registering original and reproduced drugs and types of equivalence, as well as problems with generics in clinical practice. The results of pharmacoepidemiological studies, widely leading in recent years, indicate an insufficient study of the influence of reproduced drugs on remote outcomes of chronic diseases, including mortality. The long-term economic prospect of the use of reproduced drugs remains unclear. The main reasons for the difference between the original and reproduced drugs include differences in the methods of synthesis of active substances, as well as as part of auxiliary substances and impurities. Comparative studies of the therapeutic equivalence of generics with the original and are carried out quite rarely and often suffer from methodological disadvantages, which does not guarantee comparable efficiency and safety of such drugs. In this regard, the automatic replacement of drugs containing the same active substance, without the participation of the attending physician, should be avoided.

Keywords: generics; bioequivalence; pharmaceutical equivalence; therapeutic equivalence; interchangeability.

The effectiveness and safety of Mexidol in patients of different age groups in the acute and early recovery periods of the hemisphere ischemic stroke (the results of subanarized a randomized double blind multicenter placebo-controlled in parallel groups of the study of epic)

Authors:
L.V. Stakhovskaya 1 , E.A. Mkhitaryan 2 , O.N. Tkachev 1.2 , T.M. Ostroumova 3 , O.D. Ostroumova 3.4

1 FGAOU in Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia;
2 Russian Gerontological Scientific and Clinical Center of the FGAOU in the Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia;
3 FGAOU in the First Moscow State Medical University named after THEM. Sechenov »Ministry of Health of Russia (Sechenov University), Moscow, Russia;
4 FSBEI of DPO “Russian Medical Academy of Continuing Professional Education” of the Ministry of Health of Russia, Moscow, Russia

Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2020, T.120, No. 8, Issue 2

Summary:
Purpose of the study. To evaluate the effectiveness and safety of prolonged sequential therapy with Mexidol with a hemisphere ischemic stroke in acute and early recovery periods in patients of various age groups.

Material and methods. The study is an additional analysis of age groups among 150 patients who took part in a randomized double blind multicenter placebo-controlled in parallel groups of the epic study. The entire study of the study (62 men and 88 women) was divided into subgroups by age: under 60 years old, 60–75 years old, 76–90 years. Also, all participants in the study were divided into 2 populations: ITT (Intent to Treat Population, patients who received at least one dose of the drug/placebo drug) and PP (Per Protocol Population, patients who received the drug in accordance with the research protocol). The results were evaluated on the modified Rankin scale (MSHR) at the end of the course of therapy, the Bartel index, the Bek depression scale, and the European questionnaire for assessing the quality of life.

Results. The effectiveness of Mexidol on all the scales used did not differ depending on age. At the time of the end of the therapy, the average MSHR score was lower in patients 76–90 years (in both populations) compared to placebo (p <0.001). The dynamics of reducing the average score in MSHR (1-5th visits) was more pronounced in patients of 60–75 years (p = 0.025), including patients with diabetes. In patients 76–90 years old and patients with diabetes mellitus compared to placebo, the severity of cognitive-affective symptoms of depression (p = 0.049 and p = 0.02, respectively), the share of patients with lack of problems with everyday affairs, increased statistically significant (P = P = P = P = P = P = P = P = P = P = P. 0.007 and p = 0.02, respectively). In patients with diabetes, the level of everyday activity (p = 0.023) has also increased statistically significantly significantly increased and the quality of life has improved (p = 0.045). There were no reliable differences in the frequency of unwanted phenomena in all studied groups.

Conclusion. It is recommended that the use of Mexidol in the acute and early recovery periods of ischemic stroke in all age groups, including patients with diabetes mellitus.

Key words: ischemic stroke, Mexidol, ethylmethylhydroxypyridine succinate, effectiveness and safety, ischemic stroke, acute period, early recovery period, epic.

Pharmacoeconomic analysis of neuroprotectors used in the treatment of ischemic stroke

Authors:
R.I. Yagudin 1 , A.Yu. Kulikov 1 , V.A. Krylov 1 , E.Yu. Soloviev 2 , A.I. Fedin 2

1 FGBU VO "First Moscow State Medical University named after THEM. Sechenov »Ministry of Health of Russia (Sechenov University), Moscow, Russia;
2 FSBI in Russian National Research Medical University named after N.I. Pirogov ", Ministry of Health of Russia, Moscow, Russia

Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2019, T. 119, No. 7

Summary:
Purpose of the study. Conduct a pharmacoeconomic analysis of the most frequently prescribed drugs of a group of neuroprotectors for the treatment of patients with an ischemic stroke (AI) of a mild and early recovery period in the Russian Federation. Material and methods. Three medical technologies were compared: ethylmethylhydroxypirinate (drug - LP - Mexidol), Inosin + nicotinamide + riboflavin + amber acid (LP cytoflavin) and disordered hemoderivat of blood calves (LP Actovegin). Based on the results of an indirect comparison, a pharmacoeconomic analysis was carried out through the following methods: analysis of cost minimization, analysis of “influence on the budget” and sensitivity analysis. Results. Analysis of effectiveness showed that the LP studied have equal efficiency: the difference of the average LP Aktovegin is 0.2 (di min 0.18; max 0.22), Mexol Mexidol LP (confidence interval - di - min 0.25; Max; 0.65), LP cytoflavin - 0.61 (di min 0.23; max 0.99). Analysis of the minimization of costs showed that the cost of a course of the treatment of one patient of the LP Mexol is accompanied by the lowest costs, while saving is observed when assessing both the total costs and individual components: a solution for injection and tablet forms. The savings in comparison with the LP Cytoflavin and LP Aktovegin is 231 rubles. and 12,872 rubles. respectively. It is possible to additionally treat 5 patients with AI Mexidol on saved only from one course. Moreover, the oral therapy of the Mexol Mexidol LP is more economical by 164 rubles. and 3481 rub. Therapies with similar dosage forms of the Cytoflavin and Actoveginal Public Use, which is an advantage for the population in treatment at the outpatient stage. An analysis of the impact on the budget showed that the total costs of the current distribution of patients according to treatment schemes are 1.99 billion rubles. With an increase in the share of patients receiving Mexidol LP, 10% of the total costs will amount to 1.75 billion rubles, which is 240 million rubles. Less current. On saved products, 85 thousand patients with AI can be additionally treated. A two -factor analysis of sensitivity showed that the result of the analysis of minimization of costs and the impact on the budget remains stable when the number of patients and the cost of 1 mg of Mexidol LP per amount from -10% to +10% changes. Conclusion. In the course of the indirect comparison, it was found that the LP Mexidol, the LP Cytoflavin and LP Actovegin are equal in terms of effectiveness. However, the Mexidol LP has an advantage from the point of view of analyzing the minimization of costs: there are enough funds saved from one course to treat 5 patients with II Mexidol. When considering the consequences of increasing the share of patients receiving Mexol's LP, data were also obtained indicating the savings of funds, which allows us to consider the therapy of the LP Mexoli -preserving budget -storage in the treatment of Easy degree in the Russian Federation. Key words: pharmacoeconomics, indirect comparison, analysis of cost minimization, analysis of “influence on the budget”, neuroprotectors, ischemic stroke.

Modern ideas about the antihypoxic and antioxidant effects of Mexidol

Author:
A.V. Schulkin

Place of publication:
Journal of Neurology and Psychiatry, 12, 2018, Issue. 2

Summary:
in the viewing article, a modern concept of mechanisms of antioxidant and antihypoxic effects of the original domestic drug Mexidol (2-ethyl-6-methyl-3-hydroxypirinate) is presented. The direct antioxidant activity of Mexidol is described, which consists in the ability of the drug to inactivate free radicals and increase the activity of antioxidant enzymes of glutathioneperoxidase and in vitro superoxidism. The data on the presence of an indirect antioxidant activity in the Mexidol, manifested in an increase in expression in conditions of ischemia of the transcription factor NRF2, which is responsible for the development of cell stability to oxidative stress. The anti -human action of Mexidol is discussed, due to the presence of amber acid in its molecule, which, on the one hand, maintains the operation of the serpentinexidate link in the Krebs cycle under conditions of oxygen, and on the other hand, is associated with its specific receptors (GPR91) and triggers a cascade of biochemical reactions that increase the resistance of the resistance organism to a lack of oxygen. Keywords: Mexidol, ethylmethylhydroxypirinate, antioxidant, antihypoxant.

Results of a Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Effi Cace and Safety of Mexidol in Prolonged Sequential Therapy of Patient S in the Acute and Early Recovery Stages of Hemisphereic Stroke (The Epica Study)

Authors:

LV Stakhovskaya 1 , Na Shamalov 1 , DR Khasanova 2 , Ev Mel'nikova 3 , AS AGAF'INA 4 , KV Golikov 5 , AA Yakupova 6 , LV Roshkovskaya 7 , LV LUKINYKH 8 , T. M Lokshtanova 9 , Ie Poverennova 10 , La SHEPANKEVICH 11

1 Research Institute of Cerebrovascular Pathology and Stroke, Pirogov Russian National Research Medical University, Russian Ministry of Health, Moscow, Russia.
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 Administrate 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 Internal 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.

Place of publication:
Neuroscience and Behavioral Physiology, Vol. 48, no. 8, October, 2018

Summary:
Objectives. To Assess The Effi Cace and Safety of Prolonged Sequential Therapy with Mexidol in Patients with Hemispheric Ischemic Stroke (IS) In the Acute and Early Racovery Phasses. 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 Aged 40–79 YEARS WERE RANDOMIZED. Simple Randomization Was Ussed to Defi Ne Two Groups: PATIENTS OF GROUP 1 Receved Mexidol Therapy at AT AT AT AT AT AT AT ATRAVENOS INTREaneUNUS Infusion for 10 Days followed BY INLAL DOSES of 1 tablet (125 Mg) Three Times A Day for Eight Weeks. PATIENTS OF GROUP 2 Receved Placebo by the Same Protocol. The Duration of Involved in the Trial Was 67–71 Days. Results. At the end of Treatment, Mean Scores on the Modifi Ed Rankin Scale (MRS) Were Lower in Group 1 That Group 2 (P = 0.04). Decresses in Mean Mrs Scores (At Visits 1–5) Were More Marked in Group 1 (P = 0.023). The Proportion of Patience 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 Were More Marked In Group 1 (P = P = P = 0 .038). In Group 1, The Total Population and the SubpopPulation of Paty Diabetes Mellitus Showed Morked Improvements in Quality of Life, Whis Apparent by Visit 2 Ion of Pathers with the Diffi Culty Mobilizing Was Signifi Cantly Greater in Group 1 (P = 0.022 ). There were no signifi carcasses in the frequencies of advers in patents of the Two Groups. Conclusions. Use of Mexidol in the Acute and Early Recovery Phasses of is IS Recommoded. Keywords: Acute Cerebrovascular Accident, Mexidol, EthylMethylhydroxypyridine Succinate, Effi Cace and Safety, Ischemic Stroke, Acute Phase, Early Reacovery Phase, Epica .

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 the acute and early recovery periods

Authors:

L.V. Stakhovskaya 1 , N.A. Shamalov 1 , DR Khasanova 2 , E.V. Melnikova 3 , A.S. Agafin 4 , K.V. Golikov 5 , E.I. Bogdanov 6 , A.A. Yakupova 6 , L.V. Roshkovskaya 7 , L.V. Lukin 8 , T.M. Lokstanova 9 , I.E. Patrunenova 10 , L.A. Shchepankevich 11

1 Research Institute of Cerebrovascular Pathology and Stroke of the Federal State Budgetary Institution “Russian National Research Medical University named after N.I. Pirogov »Ministry of Health of Russia, Moscow, Russia;
2 Igauz "Interregional Clinical and Diagnostic Center", Kazan, Russia;
3 St. Petersburg GBUZ "City Hospital No. 26", St. Petersburg, Russia;
4 St. Petersburg GBUZ "City Hospital No. 40 of the Resort Administrative District", St. Petersburg, Russia;
5 St. Petersburg GBUZ "City multidisciplinary hospital No. 2", St. Petersburg, Russia;
6 FSBEI in Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia;
7 St. Petersburg GBUZ "Nikolaev Hospital", St. Petersburg, Russia;
8 GBUZ "Vsevolozhsk Clinical Interdistrict Hospital", Leningrad Region, Russia;
9 Mubz "City Clinical Hospital No. 1 named after N.I. Pirogov ", Samara, Russia;
10 GBUZ "Samara Regional Clinical Hospital named after V.D. Seredavina ”, Samara, Russia;
11 FGBNU "Scientific Institute of Experimental and Clinical Medicine", Novosibirsk, Russia.

Place of publication:
a journal of neurology and psychiatry named after S.S. Korsakova, 2017, No. 3, issue 2

Summary:
Purpose of the study. To evaluate the effectiveness and safety of prolonged sequential therapy with Mexidol with patients with hemispherical ischemic stroke (AI) in acute and early recovery periods. Material and methods. 151 patients (62 men and 89 women) were included in the randomized double-centered placebo-controlled multicenter placebo-controlled in parallel research groups, 150 patients (62 men and 88 women) aged 40 to 79 years are randomized. Patients by simple randomization were distributed to 2 groups: patients of the 1st group received therapy with Mexidol of 500 mg/day intravenously for 10 days, followed by 1 tablet (125 mg) 3 times a day for 8 weeks. Patients of the 2nd group received a placebo according to a similar scheme. The duration of participation in the study was from 67 to 71 days. Results. At the time of the end of the therapy, the average score on the modified scale of Rankin (MSHR) was lower in the 1st group than in the 2nd (p = 0.04). The dynamics of reducing the average score according to MSHR (1-5th visit) was more pronounced in the 1st group (p = 0.023). The proportion of patients who have reached the recovery corresponding to 0-2 points in MSHR (5th visit) was significantly higher in the 1st group (p = 0.039). When testing on a stroke scale of the National Institute for Health to the 5th visit, the average value was lower in the 1st group (p = 0.035). A decrease in the score on the stroke scale of the National Institute for Health at the time of the end of the course of therapy regarding the initial level in patients with diabetes was more pronounced in the 1st group (p = 0.038). In the 1st group in the general population of patients and subpopulation of patients with diabetes, the dynamics of improving the quality of life was more pronounced and was observed from the 2nd visit. The proportion of patients with the lack of problems in space was significantly higher in the 1st group (p = 0.022). There were no reliable differences in the frequency of unwanted phenomena in patients of both groups. Conclusion. It is recommended that the use of Mexidol in the acute and early recovery periods of AI is recommended. Keywords: acute cerebrovascular accident, mexidol, ethylmethylhydroxypyridine succinate, effectiveness and safety, ischemic stroke, acute period, early recovery period, epic.

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