The efficacy and safety of Mexidol and Mexidol Forte 250 in patients with chronic cerebral ischemia

Author:
Yu.V. ABRAMENKO
Tver State Medical University, Tver, Russia

Summary:
Objective. To study the efficacy and safety of mexidol’s intravenous injections (500 mg once a day) for 14 days, followed by oral administration of mexidol FORTE 250 at a dose of 250 mg (1 tablet) 3 times a day for 60 days, in treatment of chronic cerebral ischemia (CCI) in patients with hypertension and atherosclerosis of the brachiocephalic arteries. Material and methods. The observation program included 60 patients with an established diagnosis of CCI confirmed by neuroimaging methods. Patients of the main group (n=26) received mexidol along with basic therapy, patients of the comparison group (n=26) received only basic therapy. Results and conclusion. The results of the experience show the high efficacy and safety of sequential therapy (parenteral therapy followed by tablets of mexidol FORTE 250). The treatment improves emotional and cognitive status, decreases static-motor disorders and severity of subjective neurological symptoms. High adherence of patients to the therapy is shown.
Keywords: chronic cerebral ischemia, arterial hypertension, atherosclerosis of the brachiocephalic arteries, mexidol, static-motor
disorders, cognitive impairment.


The efficacy and safety of ethyl methyl hydroxypyridine succinate used as part of sequential therapy in patients with chronic cerebral ischemia

Author:
V.V. BURDAKOV, D.V. KRASNYKH
Orenburg State Medical University, Ministry of Health of Russia, Orenburg, Russia

Summary:
Objective: to investigate the efficacy and safety of Mexidol® FORTE 250 in patients with chronic cerebral ischemia (CCI) in the presence of hypertension and atherosclerosis. Patients and methods. The investigation enrolled 20 patients aged 45 to 75 years with CCI in the presence of hypertension and atherosclerosis, who received intravenous Mexidol® administered dropwise at a dose of 500 mg once a day for 14 days, followed by oral Mexidol® FORTE 250 mg thrice a day for 60 days (a study group). A control group consisted of 14 patients with CCI in the presence of hypertension concurrent with atherosclerosis, who were prescribed combination therapy for CCI without using these drugs. The patients were examined before and at 14 and 60 days of treatment. The investigators studied subjective complaints, neurological symptoms, and the indicators of the Tinetti Performance Oriented Mobility Assessment in Elderly Patients; the Montreal Cognitive Assessment (MoCA); the Hamilton Anxiety Rating Scale (HARS); asthenia rating scales (Multidimensional Fatigue Inventory, MFI-20); and the Clinical Global Impression (CGI) scale over time. Results and discussion. Therapy with Mexidol® in patients with CCI in the presence of hypertension and atherosclerosis was found to be accompanied by positive changes in the asthenia rating scale MFI-20, cognitive functions assessed by MoCA, as well as Tinetti movement coordination. No significant differences in these indicators were noted in patients of the control group. Combination treatment for CCI with Mexidol® and Mexidol® FORTE 250 as a sequential therapy was twice more effective than that without using these drugs, as shown by the scales as a whole and it was up to 10 times greater for individual scale parameters. Conclusion. The study of Mexidol® FORTE 250 as part of the sequential therapy, which was used according to the above regimen, indicates its clinical efficacy and safety in patients with CCI.
Keywords: chronic cerebral ischemia, cognitive and motor functions, asthenic and anxiety-depressive disorders, Mexidol® FORTE 250.


The efficacy of ethylmethylhydroxypyridine in the rehabilitation treatment of poststroke patients

Author:
O.V. M.V. ZHURAVLEVA1,2, A.B. PROKOFIEV1,2, V.V. ARKHIPOV1, S.YU. SEREBROVA1,2, G.I. GORODETSKAY1,2, O.A. DEMIDOVA1

1 Research center for examination of medical devices, Moscow, Russia

2 Sechenov First Moscow state medical University (Sechenov University), Moscow, Russia

Summary:
The analysis of the clinical efficacy and safety of ethylmethylhydroxypyridine succinate (mexidol) in the complex of rehabilitation measures in patients after ischemic stroke (IS) shows that course treatment with mexidol improves the recovery of neurological functions, decreases neurological deficit, cognitive disorders, including memory impairment, and manifestations of asthenic syndrome, increases the level of social adaptation and improves the psycho-emotional state of patients, reduces spasticity, increases motor and speech activity, praxis, reliably eliminates the ignoring syndrome. There is a decrease in the level of total cholesterol and low-density b-lipoproteins in the blood, and decrease in the severity of hypercoagulation. The results of the studies have convincingly shown the efficacy of mexidol at all stages of rehabilitation treatment of patients with IS.
Keywords: ethylmethylhydroxypyridine succinate, mexidol, rehabilitation, recovery, stroke.


Efficacy and safety of the drug Mexidol forte 250 as part of long-term sequential therapy in patients with carotid stroke

Author:
I.A. STRELNIKOVA1, A.A. SVETKINA1,2, O.V. ANDROFAGINA1

1 Samara Regional Clinical Hospital named after V.D. Seredavina, Samara, Russia;

2 Samara State Medical University, Samara, Russia

Summary:
Objective. To evaluate an effect of long-term sequential therapy with mexidol and mexidol forte on the functional outcome of patients with carotid ischemic stroke. Material and methods. The study included 50 patients with newly developed carotid stroke, hospitalized in the stroke unit on the first day from the onset of the disease. Patients of the main group (n=25) received mexidol in a dose of 500 mg intravenously once a day for 14 days, then mexidol forte 250 in tabs 250 mg 3 times a day for 60 days. Patients of the comparison group (n=25) received standard basic therapy. The significance of intergroup differences was assessed using the Mann—Whitney test, Fisher’s exact test, and relative risk (OR) calculation. Differences were considered significant at a level of p<0,05. Results. After 14 days of therapy, both groups of patients showed a positive trend compared to baseline. At the same time, patients of the mexidol group had a higher MoCA score (U=173,5, p=0,006), a lower score when performing tasks on dynamic praxis (U=214,0, p=0,028) and optical spatial disturbances (U=170,5, p=0,003), better memorization strength (181,5, p = 0,006) and better performance on abstraction MOCA subtest (U=200,5, p=0,014). By the 74th day, the absence of moderate cognitive impairment (MoCA> 26 points) was diagnosed in 17 patients (68%) of the main group and 14 patients (56%) of the comparison group. No significant differences were found. Moreover, patients of the main group had a significantly lower NIHSS score (U=124,0, p<0,001) and a lower degree of disability: a total mRS score 0—2 was achieved in 19 (76%) patients of the main group and only in 12 (48%) patients of the comparison group (OR=3,34, F=0,07, p<0,05). Also, patients receiving long-term sequential therapy with mexidol and mexidol forte 250 had milder spatial disorders than patients of the comparison group. Conclusion. Consecutive treatment with mexidol and mexidol forte 250 in the acute and early recovery periods of ischemic stroke positively affects the regression of local neurological symptoms, increases the likelihood of achieving independence in everyday life by 3,34 times, and reduces the severity of optical-spatial, neurodynamic and memory impairments.
Keywords: ischemic stroke, mexidol, mexidol forte 250, cognitive impairment, functional outcome.


Possibility of application Mexidol for the treatment of patients suffering from sensorineural hearing loss and cerebrovascular insufficiency

Author:
N.L. KUNELSKAYA1, 2, YU.V. LEVINA1, 2, E.S. YANYUSHKINA1, D.S. OGORODNIKOV1, 2, E.V. LARIONOVA1
1 L.I. Sverzhevskiy Research Institute of Clinical Otorhinolaryngology, Moscow Health Department, Moscow, Russia, 117152;
2 Department of Otorhinolaryngology N.I.Pirogov Russian National Research Medical University (RNRMU), Moscow, Russia,117997

Summary:
Sensorineural hearing loss can develop as a consequence of vascular pathology. The etiology and pathogenesis of chronic sensorineural hearing loss allow us to consider promising the use of neuroprotective drugs in the treatment regimen that can activate the function of the neural structures of the auditory pathway. Ethylmethylhydroxypyridine succinate, having complex pharmacological capabilities and a wide range of effects realized at the neural and vascular levels can be used in the treatment of hearing impairment and speech intelligibility.
Keywords: hearing loss, sensorineural hearing loss, rehabilitation of auditory function, Ethylmethylhydroxypyridine succinate.


The study of the efficacy and safety of Mexidol and Mexidol Forte in patients with chronic cerebral ischemia

Author:
V.A. KUTASHOV, O. V. ULYANOVA
Voronezh State Medical University. N.N. Burdenko, Voronezh, Russia

Summary:
Objective. To study the efficacy and safety of Mexidol used intravenously (500 mg 1 time per day) for 14 days, followed by the oral administration of Mexidol Forte 250 in a dose of 250 mg 3 times a day for 60 days, in patients with chronic cerebral ischemia (CCI). Material and methods. The study included 56 patients with CCI due to a combination of hypertension and atherosclerosis. The results of physical examinations (control of blood pressure, heart rate etc.), dynamics of complaints, scores on CGI, MoCa, MFI‑20, HRSD, HARS and the Tinetti test were evaluated. Results and conclusion. The high level of efficacy and safety of intravenous injections of Mexidol followed by the oral administration of Mexidol Forte 250 are demonstrated. This scheme of therapy contributes to a significant decrease in the objective and subjective symptoms of CCI, leads to improvements in the emotional, cognitive and motor spheres.
Keywords: chronic brain ischemia, atherosclerosis, arterial hypertension, motor disorders, cognitive disorders, Mexidol, Mexidol Forte 250.


Efficacy and safety of the drug mexidol FORTE 250 as part of sequential therapy in patients with chronic ischemia of the brain

Author:
E.I. CHUKANOVA, A.S. CHUKANOVA
Pirogov Russian National Research Medical University, Moscow, Russia

Summary:
Objective. To study the efficacy and safety of mexidol dripped intravenously (500 mg once a day) in the form of infusions for 14 days, followed by oral administration of mexidol FORTE 250 at a dose of 250 mg (1 tablet) 3 times a day for 60 days, in treatment of chronic brain ischemia in patients with hypertension and atherosclerosis. Material and methods. The open observation program included 60 patients with an established diagnosis of chronic brain ischemia confirmed by neuroimaging methods. Results and conclusion. The results of the study show the high efficacy and safety of sequential therapy (injections followed by tablets of mexidol FORTE 250). The treatment improves emotional and cognitive status, decreases motor disorders and severity of subjective manifestations. High adherence of patients to the therapy is shown.
Keywords: chronic cerebrovascular disease, arterial hypertension, atherosclerosis, ethylmethylhydroxypyridine succinate, mexidol, c ognitive impairment.


Review of clinical guidelines for the treatment and prevention of ischemic stroke

Author:
A.I. FEDIN, K.R. BADALYAN

Pirogov Russian National Research Medical University, Russian Ministry of Health, Moscow, Russia

Summary:
One of the leading causes of death, disability and severe maladaptation of patients is ischemic stroke, which accounts for about 80% of all types of acute cerebrovascular accidents. At the same time, approximately 2/3 of the patients show residual effects of cerebral circulation disorders of varying severity. Currently, the problem of ischemic stroke attracts great attention and international and domestic recommendations developed for the prevention, treatment and rehabilitation of stroke patients are one of the aspects of work in this area. The article provides an overview of the latest clinical guidelines for the early management of patients with acute ischemic stroke of the American Heart Association and the American Stroke Association, as well as features of stroke therapy and prevention in Russia, Europe and USA. Keywords: ischemic stroke, clinical guidelines, therapy of ischemic stroke.


Pharmacoeconomic analysis of the neuroprotective medicines in the treatment of ischemic stroke

Author:
R.I. YAGUDINA1, A.YU. KULIKOV1, V.A. KRYLOV1, E.YU. SOLOVIEVA2, A.I. FEDIN2

1Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia;
2Pirogov Russian National Research Medical University N.I.Pirogov Russian National Research Medical University of the Ministry of Health
of Russia, Moscow, Russia

Summary:
Objective. To perform a pharmacoeconomic analysis of the most frequently prescribed neuroprotective medicines for treating patients with mild ischemic stroke in the acute and early rehabilitation periods in the Russian Federation. Material and methods. Three medical technologies were compared: ethylmethylhydroxypyridine succinate (mexidol), inosine + nicotinamide + riboflavin + succinic acid (cytoflavin) and a deproteinized hemoderivate of the blood of calves (actovegin). Cost minimization analysis, budget impact analysis and sensitivity analysis were performed based on the indirect comparison results. Results. Efficacy analysis shows that mentioned above medicines have the same efficacy: mean difference mexidol is 0,2 (CI min 0,25; max 0,65), cytoflavin — 0,61 (CI min 0,23; max 0,99), actovegin 0,2 (CI min 0,18; max 0,22). The cost minimization analysis for the Russian Federation shows that mexidol therapy is associated with the lowest costs, while savings are observed both in the evaluation of total costs and separate components: intravenous ampoules and tablet forms. The savings in comparison with cytoflavin and actovegin are 231 RUB and 12,872 RUB, respectively. These savings will be enough to treat five patients with ischemic stroke (IS) with mexidol. Moreover, oral mexidol therapy is cheaper than the same dosage forms of cytoflavin and actovegin by 481 RUB and 3,164 RUB, respectively. This is an advantage for the treatment of population at the outpatient stage. Budget impact analysis has shown that the budget for the medicines for treating IS at the current distribution between treatment regimens, is estimated at 1.99 BN RUB. The increase in the proportion of patients receiving mexidol by 10% reduces total costs to 1.75 BN RUB, which is 240 M RUB less than current costs. With these savings 85 thousand patients with IS could be treated. The sensitivity analysis reveals that the result of the cost minimization analysis and the budget impact analysis remain stable when both the amount of the population and the cost of 1 mg of mexidol vary from –10% to + 10%. Conclusions. Mexidol has the same efficacy as alternatives. However mexidol is superior to cytoflavin and actovegin in terms of cost minimization analysis. The savings from one course of alternatives will cover costs of treatment of five patients with IS using mexidol. The increase in the proportion of patients receiving mexidol is associated with savings, which allows us to consider mexidol therapy of mild IS as budget-saving in the Russian Federation. Keywords: pharmacoeconomics, indirect comparison, cost minimization analysis, budget impact analysis, neuroprotectors, ischemic stroke.


Evaluation of blood rheology by patients with acute ischemic stroke with Mexidol administration

Author:
D.M. PLOTNIKOV1, M.N. STEGMEIER1, O.I. ALIEV2

1 Department of Neurology and Neurosurgery, Siberian State Medical University, Tomsk, Russia;
2 Goldberg Research Institute of Pharmacology and Regenerative Medicine, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia

Summary:
Objective. To study rheological properties of blood in patients with acute ischemic stroke treated with mexidol. Material and methods. Sixty patients with acute stroke, including 32 patients who received mexidol (500 mg/IV/20 days) and 28 people who received magnesium sulfate (2000 mg/IV/20 days) were examined. The control group included 20 people without a cardiovascular pathology. Blood rheology (viscosity of whole blood, plasma viscosity, hematocrit, aggregation and deformability of erythrocytes, fibrinogen level) was evaluated in patients three times: for the first 12 hours, 3—5 days and 18—20 days after hospitalization. Results. Hyperviscosity syndrome was observed in all patients with stroke. A significant decrease in blood viscosity was found in patients treated with mexidol: in the 3–5th day at low shear rates and in the 18—20th day at 3—100 s–1 shear rates. Significant differences in hematocrit (p=0.026) and fibrinogen levels (p=0.017) in patients treated with different drugs were found in the 18—20th day of the disease. Higher erythrocyte deformability index was recorded in patients treated with mexidol in the 3—5th day at shear rates of 90 and 890 s–1, in the 18—20th day at shear rates of 90—360 s–1. Conclusion. The study confirms the impact of mexidol on the fluidity of blood during the acute cerebral ischemia and shows its efficacy in reducing blood viscosity, decreasing the level of hematocrit and fibrinogen, increasing the deformability of erythrocytes.
Keywords: acute ischemic stroke, rheological parameters of blood, blood viscosity, erythrocytes deformability, mexidol (ethylmethylhydroxypyridine succinate), treatment of stroke.