Study of the efficacy and safety of sequential use of the drugs Mexidol and Mexidol FORTE 250 in the treatment of stroke
Author:
S.M. KARPOV1, M.YU. MOROZOVA2, K.A. MURAVYOV2, I.A. VYSHLOVA1, F.S. KANTEMIROVA3
1Stavropol State Medical University, Stavropol, Russia;
2City Clinical Hospital No. 3, Stavropol, Russia;
3Georgievsky Medical Academy, Simferopol, Russia
Summary:
Objective. To evaluate the effect of Mexidol on the recovery of cognitive functions in patients after ischemic stroke (IS). Material and methods. We examined 70 patients with acute IS, who were randomized into 2 groups by random sampling; The 1st group consisted of patients who, against the background of the main standard therapy for 14 days, received Mexidol intravenously, 500 mg 1 time per day, followed by oral administration of Mexidol FORTE 250, 750 mg per day for 60 days (40 patients; 28 men, 12 women). Group 2 consisted of 30 patients (21 men, 9 women) who received only standard therapy. Results. Baseline scores on the MoCA and MMSE scales did not differ between the two groups. Retesting showed that the improvement on these scales was statistically more significant in the 1st group. The analysis of indicators of the evoked potential P300 confirmed a more pronounced positive trend in the 1st group (p<0.01). Conclusion. The use of sequential therapy with Mexidol is accompanied by a more complete recovery of cognitive functions in patients who have undergone IS. Keywords: stroke, acute cerebrovascular accident, cognitive impairment, Mexidol, Mexidol FORTE 250.
Generic drugs: benefit/risk ratio
Author:
Ushkalova E.A.1, Zyryanov S.K.1,2, Gopienko I.A.1
1Peoples' Friendship University of Russia (RUDN University), Moscow;
2City Clinical Hospital Twenty-Four, Moscow Healthcare Department, Moscow, Russia
Summary:
The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice. Results of pharmacoepidemiological studies, which have been widely carried out recently, speak of insufficient understanding of the impact of generics on remote outcomes of chronic diseases, including mortality. The longterm economic prospects of generic drug administration continue to remain unclear. Among the primary differences between generics and brandname drugs are the differences in active ingredient synthesis methods and the composition of adjuvants and additives. Comparative studies on the therapeutic equivalence of generics with their originals or between themselves are rarely conducted. They are often affected by methodological flaws, which cannot ensure their comparable efficacy and safety. In this regard, automatic replacement of drugs containing the same active ingredient should be avoided without the participation of the attending physician. Keywords: generics; bioequivalence; pharmaceutical equivalence; therapeutic equivalence; interchangeability.
Original and generic drugs: what does the clinician need to know?
Author:
A.V. SHCHULKIN, A.A. FILIMONOVA
Ryazan State Medical University, Ryazan, Russia
Summary:
In the review article modern approaches to testing and registration of generic drugs are discussed. The article presents the history of the formation of the methodology for testing generic drugs and the current legislation of the Russian Federation. The stages of confirmation of equivalence of original and generic drugs are described: pharmaceutical equivalence, bioequivalence and therapeutic equivalence. The methods of assessing bioequivalence — as the main research in the registration of generic drugs — are discussed in detail. Using the example of the original neuroprotector — Mexidol (ethylmethylhydroxypyridine succinate) and its generics, it is described how legislative acts are implemented in practice. It is concluded that not all generic drugs are interchangeable for the original drug. Keywords: original and generics drugs, ethylmethylhydroxypyridine succinate, mexidol.
The efficacy and safety study of Mexidol and Mexidol FORTE 250 in patients with chronic cerebral ischemia
Author:
L.A. SHCHEPANKEVICH1,2, YU.A. NIKOLAEV1, E.V. TANEEVA3, M.A. PERVUNINSKAYA1, M.S. SHCHEPANKEVICH1,2
1Federal Research Center of Fundamental and Translational Medicine, Novosibirsk, Russia;
2Novosibirsk State Medical University, Novosibirsk, Russia;
3State Novosibirsk Regional Clinical Hospital, Novosibirsk, Russia
Summary:
Objective. To study the efficacy and safety of sequential MexidoL therapy, administered intravenously (500 mg once a day) for 14 days, followed by taking the oral form Mexidol FORTE 250 at a dose of 250 mg (1 tablet) 3 times a day for 60 days in elderly patients with chronic cerebral ischemia (CCI) on the background of arterial hypertension and atherosclerosis. Material and methods. An open prospective observational study included 60 patients with an established diagnosis (CCI), confirmed by the results of neuroimaging. All patients were examined with an assessment of neuropsychological status (MoCA test), severity of asthenia (scale MFI-20), emotional state (Hamilton anxiety and depression scale), motor functions (formalized clinical scale for assessing motor activity of elderly Tinetti). The effectiveness of the therapy was evaluated according to the quality of life questionnaire (SF-36). Results. The results of the study showed the high efficiency and safety of sequential therapy with Mexidol in relation to the relief of asthenic and emotional disorders, improving the state of cognitive functions, improving the quality of life of patients. The maximum effect occurred after the end of the full course of therapy. High adherence of patients to the therapy, low frequency of adverse events are shown. Conclusion. Sequential use of intravenous administration of Mexidol followed by oral administration of Mexidol FORTE 250 is an effective and safe way to treat patients with CCI. Keywords: chronic cerebrovascular disease, arterial hypertension, atherosclerosis, ethylmethylhydroxypyridine succinate, mexidol, mexidol forte 250, cognitive impairment.
Results of an international multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of sequential therapy with Mexidol and Mexidol FORTE 250 in patients with chronic brain ischemia (MEMO)
Author:
A.I. FEDIN1, V.V. ZAKHAROV2, M.M. TANASHYAN3, E.I. CHUKANOVA1, E.N. MADZHIDOVA4, L.A. SHCHEPANKEVICH5,6, O.D. OSTROUMOVA7
1Russian National Research Medical University named after N.I. Pirogov, Moscow, Russia;
2Sechenov First Moscow Medical University (Sechenov University), Moscow, Russia;
3Scientific Center of Neurology, Moscow, Russia;
4Tashkent Pediatric Medical Institute, Tashkent, Republic of Uzbekistan;
5Novosibirsk State Medical University, Novosibirsk, Russia;
6Federal Research Center for Fundamental and Translational Medicine, Novosibirsk, Russia;
7Russian Medical Academy of Continuous Professional Education, Moscow, Russia
Summary:
Objective. To assess the efficacy and safety of sequential therapy with Mexidol solution for intravenous and intramuscular administration, 50 mg/ml and Mexidol FORTE 250 film-coated tablets, 250 mg in patients with chronic brain ischemia (CBI). Material and methods. An international multicenter, randomized, double-blind, placebo-controlled trial, conducted in 15 clinical centers located in Russian Federation and Republic of Uzbekistan, included 318 patients with CBI aged 40 to 90 years. The patients were randomized into 2 groups, the patients of the 1-st group received Mexidol intravenously 500 mg once daily for 14 days, followed by Mexidol FORTE 250 — 250 mg 3 times a day orally for 60 days; patients of the 2-nd group received a placebo in a similar mode. The primary endpoint was the mean value of difference by MoCA scale at the point of completing the therapy comparing to initial value. Results. According to the results of the assessment of the primary endpoint, statistically significant changes in the MoCA scores at the stage of completion of study were revealed when comparing the dynamics between the 1-st and 2-nd groups (p<0.000001). The lower limit of the 95% confidence interval for the difference in the average of the main efficacy endpoint between the 1-st and 2-nd groups was 1.51, which allows to state a higher efficacy of the use of Mexidol. According to the estimates of secondary endpoints, a statistically significant advantage over placebo at the last visit achieved while evaluation by the following scales and tests: digit symbol substitution test, MFI-20 asthenia assessment scale, Beck anxiety scale, Vane questionnaire, Tinetti scale, SF-36 questionnaire (mental component of health), CGI scale. The comparable nature of the safety profile of Mexidol and Placebo was established. Conclusion. The validity and expediency of the use of Mexidol and Mexidol FORTE 250 in the treatment of patients with CBI has been demonstrated. Keywords: chronic brain ischemia, cognitive impairment, neuropsychological testing, ethylmethylhydroxypyridine succinate, Mexidol, Mexidol FORTE 250, treatment of CBI, MEMO trial.
Vascular inflammation underlies the development of atherothrombotic stroke
Author:
A.V. ROMANENKO, I.P. AMELINA, E.YU. SOLOVYEVA
Pirogov Russian National Research Medical University, Moscow, Russia
Summary:
Atherothrombotic stroke is the one of the most common subtypes of ischemic cerebral circulatory disorders, the cause of which is atherosclerosis of the major arteries of the brain or their branches. The results of recent studies have shown that the atherosclerotic process is based on an inflammatory process in the vascular wall that leads to the initiation of atherosclerosis, endothelial dysfunction, oxidative stress, and the redistribution of various protein components in the blood-brain barrier. As a result, the progression of the described conditions leads to the manifestation of clinical symptoms and the formation of an acute vascular event. Understanding of the molecular components underlying functional disorders and damages of the cerebral vessels gives the key to modern therapy strategies. It is forming the foundation for the adequate, pathogenetically reasonable drug correction. For such patients, it should be aimed at the normalization of cerebral and central hemodynamics and incorporate the mechanisms of neuroplasticity. The drug 2-ethyl-6-methyl-3-oxypyridine-succinate (mexidol) can be considered as one of the pathogenetically justified agents in complex drug therapy of brain ischemia. Keywords: ischemic stroke, atherosclerosis, vascular inflammation, oxidative stress, endothelial dysfunction, ethylmethylhydroxypyridine succinate.
Features of the patient management with traumatic brain injury
Author:
M.L. CHUKHLOVINA1, A.A. CHUKHLOVIN2
1Almazov National Medical Research Center, Ministry of Healthcare, St. Petersburg, Russia
2Polenov Russian Research Neurosurgical Institute — Branch Almazov National Medical Research Center, St. Petersburg, Russia
Summary:
The aim of our study was to consider features of pathogenesis, diagnosis and therapy of traumatic brain injury (TBI) from the viewpoint of neurologist. The mechanisms of emerging injury of the central nervous system, including neuro-inflammation and oxidative stress in patients with TBI, and correlations between clinical manifestations and severity of TBI are discussed. Special attention is paid to the description of certain TBI consequences, e.g. structural drug-resistant epilepsy and post-traumatic stress disorder. We provide evidence for difficulties and lesser availability of rehabilitation programs to patients with TBI during COVID-19 pandemics. One should mention a need for administration of Mexidol as the antioxidant/antihypoxant drug into complex therapy of TBI in such patients. In the period of COVID-19 pandemics, the role of neurologist in management of TBI patients still increases, especially, at the outpatient treatment stage, and when carrying out therapy and medical rehabilitation programs. Keywords: traumatic brain injury, oxidative stress, structural drug-resistant epilepsy, posttraumatic stress disorder, SARS-CoV-2 infection, Mexidol.
Features of responding to stress of elderly patients with chronic brain ischemia
Author:
T.A. SLYUSAR, YU.V. ABRAMENKO, S.S. RUBINA, R.V. MAYOROV, I.N. SLYUSAR
Tver State Medical University, Tver, Russia
Summary:
The aim of the study. To study the peculiarities of responding to stress, the stress resistance and adaptation of older men and women with chronic brain ischemia, as well as the stressboard effect of Mexidol. Material and methods. 124 patients aged 60–74 years old are surveyed: 72 men and 52 women (average age, respectively, 65.3 ± 0.4 and 64.7 ± 0.7 years) with Chronic Brain Ischemia I–II stage against the background of arterial hypertension and its combinations with atherosclerosis of cerebral vessels. The level of psychosocial stress was determined on the Holmes-Ray scale. Features of the response of patients to stress was studied using the methodology Scale of Psychological Stress PSM‑25 and S. Rogenzweig. Stress resistance was investigated using S. Kuhlen's stress resistance self-resistant test and Villianson. The level of anxiety was determined using a scale of Ch. D. Spilberger and Yu. L. Khanin, depressed – backup questionnaire. The type of adaptation reactions was studied in the leukocyte blood formula on the percentage ratio of lymphocytes and segmented neutrophils, taking into account the representation of other formed elements. Results. The level of stress in older women with Chronic Brain Ischemia was higher than in men. The predominance of the intrinsic orientation of the reaction to stress and resolving the type of response to men, and the extrapunitive or self-defense type among women, which may indicate the largerness of the latter. The level of stress resistance was lower in women than in men, which correlated with higher indicators of situational anxiety. Adverse adaptation reactions were more often registered in women than in men. The course of treatment with Mexidol of elderly patients with chemical leads to a decrease in the severity of subjective and objective symptoms, alarming disorders, increases the stress resistance and adaptive capabilities of the body, which is confirmed by an increase in the number of persons with favorable adaptation reactions. The high efficiency and safety of sequential therapy with Mexidol (injections, then the tableted form of Mexidol Forte 250) is shown. Keywords: chronic brain ischemia, sex, stress, stress resistance, emotional disorders, anxiety, depression, Mexidol, adaptation reactions.
The efficacy of antioxidant treatment with mexidol forte in 250 patients with chronic cerebral venous insufficiency
Author:
E.I. CHUKANOVA, A.S. CHUKANOVA, KH.I. MAMAEVA
Pirogov Russian National Research Medical University, Moscow, Russia
Summary:
Objective. To study the efficacy and safety of complex treatment with 2-ethyl-3-hydroxy-6-methylpyridine (mexidol forte 250) and venotonic drugs L-lysine aescinat and diosmin/hesperidin in patients with chronic cerebral venous insufficiency (CCVI). Material and methods. One hundred and twenty CCVI patients with clinical and ultrasonic signs of cerebral venous discirculation were studied. Patients were stratified into group 1 (n=40) treated perorally with mexidol forte 250 and diosmin/hesperidin during 74 days in combination with two courses of L-lysine aescinat intravenously on the 1st and 30th days from baseline, group 2 (n=40) treated with mexidol forte 250 and diosmin/hesperidin during 74 days, group 3 (n=40) treated perorally with diosmin/hesperidin during 74 days. Results and conclusion. The efficacy and safety of the complex treatment of CCVI patients with venotonic drugs with the inclusion of mexidol forte 250 at a dose of 750 mg/day for 74 days is shown. The study demonstrates a significant positive effect of mexidol forte 250 on the dynamics of complaints and indicators of the neurological and psychoemotional status of patients. Monotherapy with the venotonic drug diosmin/hesperidin shows its insufficient efficacy. Keywords: chronic cerebral venous insufficiency, antioxidants, mexidol forte 250, venotonic drugs, L-lysine aescinat, diosmin/hesperidin.
Possibilities of improving the effectiveness of therapy in patients with chronic cerebral ischemia against the background of COVID-19
Author:
V.V. KOVALCHUK, I.I. ERSHOVA, N.V. MOLODOVSKAYA
Semashko City Hospital No. 38, St. Petersburg, Russia
Summary:
Objective. To study the possibility of improving the efficacy of treatment with mexidol in COVID‑19 patients with chronic cerebral ischemia (CCI). Material and methods. Three hundred and four patients with CCI and COVID‑19 were observed, group 1 (n=152) consisted of patients receiving basic therapy and mexidol, group 2 (n=152) received only basic therapy. Mexidol was administered intravenously for 14 days, 500 mg (10 ml) per 400 ml of saline solution, then Mexidol FORTE 250 was administered in a dose of 250 mg 3 times a day for 2 months. The state of cognitive functions (MoCA scale), sleep (Spiegel questionnaire), asthenia (MFI-20 scale), and quality of life (SIP questionnaire) were evaluated. Examinations were performed before treatment, 30 and 75 days after start of treatment. Results. In group 1, there was a more complete and earlier recovery of the state of cognitive functions (an increase in indicators on the MoCA scale, p<0.01), a regression of asthenia (p<0.05), and normalization of sleep (p<0.01). By the end of the study, there were significantly more patients in group 1 with complete or significant recovery of all quality of life indicators. Conclusion. Long-term sequential therapy with mexidol provides a more complete recovery of impaired functions in patients with CCI and COVID-19. Keywords: COVID-19, SARS-CoV-2, chronic cerebral ischemia, asthenia, cognitive disorders, dementia, quality of life, mexidol.