Generic drugs: benefit/risk ratio

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

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?


Ryazan State Medical University, Ryazan, Russia

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.

Combined administration of mexidol with known medicines


Research Zakusov Institute of Pharmacology, Moscow, Russia

This review summarizes the available data on the combined administration of mexidol with medicines of different pharmacotherapeutic groups. Mexidol has a multifaceted mechanism of action and exhibits a wide range of pharmacological effects. It enhances therapeutic effects of a variety of drugs in research and clinical settings, boosts the effectiveness of therapy prescribed in accordance with the applicable federal standards and contributes to reducing the severity of complications. Effectiveness data and pathogenetic considerations underpinning combination therapy with mexidol and other drugs suggest that this is a viable approach for treating cerebrovascular and cardiovascular diseases, diseases of the nervous system, open-angle glaucoma and alcohol intoxication as well as a number of other diseases.

Keywords: mexidol, combination therapy, free radicals, lipid peroxidation, ischemic stroke, myocardial infarction, ischemic heart disease, epilepsy, alcohol intoxication.

Experience with mexidol in neurological practice


Federal Research Center «Informatics and Management», Institute of Pharmacoinformatics, RAS, Moscow, Russia; Research Institute of
Central Research Hospital of the Russian National Research Medical University. N.I. Pirogova, Moscow, Russia; FGBOU VO «Kemerovo
State Medical University» MH RF, Kemerovo, Russia; Federal State Autonomous Institution «National Medical Research Center for
Neurosurgery named after Academician N.N. Burdenko» of the Ministry of Health of the Russian Federation, Moscow, Russia

Antihypoxic, antioxidant and nootropic effects of mexidol contribute to the improvement of patients with cerebrovascular pathology. The results of clinical studies show that the sequential scheme of using mexidol (first i.v. or i.m., then per os) is effective in the complex therapy of ischemic diseases of the brain, vascular surgery, therapy and rehabilitation of patients with degenerativedystrophic changes of the spine, treatment of neurodegenerative pathology (including multiple sclerosis, Parkinson’s disease and diabetic polyneuropathy), infectious neuropathies (ARVI, herpes, tick-borne encephalitis), neuropsychological and autonomic disorders.

Keywords: neurotransmission, GABA, acetylcholine, antihypoxants, nootropics, data mining, mexidol.

Side effects of psychopharmacotherapy in patients with the syndrome of dementia and the ways of its correction


The purpose of the study. Analysis of side effects of treatment with neuroleptics in patients with the syndrome of dementia of Alzheimer’s type. Evaluation of the effectiveness of the correction of side effects of treatment with neuroleptics with the additional use in the treatment of ethylmethylhydroxypiridine succinate (Mexidol®). Materials and methods. The study included 150 patients with Alzheimer’s disease with behavioral and psychotic disorders. The average duration of disease was 4.8 years. The average age of patients was 79,8±3,2 years. All patients received basic anti-dementia therapy for 2,6±1,4 years. Additionally patients were getting neuroleptic therapy within 4,2 ±1,2. The analysis of the character and intensity of the newly appeared side effects was based on the complaints of the relatives who were taking care e of patients and results of neurological examination. The comparative analysis of effectiveness of dose=reduction correction of side effects of neuroleptics was performed in two groups of patients. In the main group (n=76) the therapy included of Mexidol® 5,0–10,0 ml (250–500 mg), by parenteral route, No. 10–15. In the control group (n=74) the medicine was not administered. Evaluation of the effectiveness of treatment was based on a scale of Global Clinical Impression (CGI-I) after treatment. The results and conclusion. Side effects associated with neuroleptic therapy included the following most frequent and early appearing: reversible extrapyramidal disturbances such as akathisia and parkinsonism. They disappeared with a dose reduction of the antipsychotic medicine. While choosing pharmacotherapy it’s necessary to give preference to low doses of atypical neuroleptics. Additional parenteral therapy with ethylmethylhydroxypiridine succinate (Mexidol®) 5,0–10,0 ml (250–500 mg) No. 10–15 effectively (p<0,05) provides a more rapid reduction of side effects from neuroleptic therapy.

Keywords: Alzheimer’s Disease, dementia, psychotic symptoms, antipsychotics, Mexidol®.

The efficacy of mexidol in carotid endarterectomy procedure in patients with cerebral atherosclerotic stenosis

North-Western State Medical University named after I.I. Mechnikov, Saint-Petersburg

Objective - to determine the antihypoxic efficacy of mexidol in carotid endarterectomy (CE) procedure in patients with cerebral atherosclerotic stenosis using cerebral oximetry. Material and methods. Clinical/psycho/neurological monitoring was performed in 109 patients with internal carotid artery stenosis of 69±7.0% and neurological symptoms of cerebral ischemia, 2-3 degree, in pre- and postoperative periods. Cerebral oximetry was carried out perioperatively. Fifty-four patients were treated with mexidol in a dose of 1000 mg/day for 14-15 days and 55 patients did not received mexidol. Results and conclusion. The difference in initial brain oxygenation (rSO2) between the main and comparison groups was shown (60.8±5.0 and 47.29±5.5%, respectively). During operation, the degree of blood oxygenation in these groups decreased by 57% and 41%, respectively. On day 7, significant differences in the Schulte test in two groups of patients with similar neurological status were found considering efficiency of work and mental stability before and after operation. No differences were found in the comparison group. Mexidol used for antihypoxic brain protection in carotid endarterectomy of patients with cerebral atherosclerotic stenosis significantly reduces the degree of cerebral hypoxia, decreases the duration of surgery, improves neurological status of patients and performance of psychological tests in postoperative period.

Keywords: cerebral stenosis, cerebral ischemia, carotid endarterectomy, cerebral oximetry, mexidol.

Efficiency mexidol in patients with endocrine polyneuropathy

Razumovsky Saratov State Medical University, Saratov; Clinical Hospital, Saratov

Objective. To evaluate the efficacy of mexidol and necessity of using it in patients with endocrine polyneuropathies caused by primary hypothyroidism (PPHT). Materials and methods. We have examined 51 patients with confirmed diagnosis of PPHT and assessed their neurological status and indicators of metabolic homeostasis before and after treatment. Electroneuromyography (ENMG) was performed to assess the status of the peripheral nervous system. Results. The results indicate the presence of endocrine disorders of obligate metabolic homeostasis in patients with polyneuropathies. Antioxidants, in particular, mexidol, in a complex with other drugs can be used in the treatment of these disorders. Worsening of ENMG-parameters, demonstrating a trend towards the normalization in response to treatment antioxidants, are characteristics of this pathology. Conclusion. The efficacy of mexidol in patients with PPHT has been confirmed.

Keywords: endocrine polyneuropathies, metabolic homeostasis, mexidol, electroneuromyography.

Diagnosis and treatment of asthenic syndrome in elderly people after acute respiratory viral infection

Samara State Medical University, Samara; Samara City Policlinic, Samara; Medical X-Ray Center, Samara

Objective: To study the characteristics of asthenic syndrome in elderly people after acute respiratory viral infection. Material and methods: We examined 87 patients with chronic cerebral ischemia and other comorbid disorders, aged from 63 to 78 years. Patients were randomized to two groups. Patients of the main group received mexidol (1 tablet (125 mg) 3 times a day during 3 weeks) along with standard treatment. Patients of the control group received standard treatment only. All patients underwent neuropsychological testing for the assessment of symptoms of asthenic syndrome. Results and Conclusion: A comparative analysis of the patient’s condition in both groups has demonstrated a reduction in symptoms of asthenia, autonomic lability and cognitive deficit in patients treated with mexidol.
Keywords: old age, asthenic syndrome, acute respiratory viral infection, treatment, mexidol.