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Actovegin® drug is one of the best sellers in the territory of CIS countries. More than 40 years ago the specialists of the Austrian branch of the Nycomed company found a substance, which helps to have an effect on many intracellular processes and influences the specific metabolic ways of body cells.
Thanks to the close cooperation of the Nycomed pharmaceutical giant (currently a Japanese pharmaceutical company – Takeda Pharmaceutical) with the Warsaw Pact countries, Actovegin® obtained the first official registration in the German Federal Republic in 1976. The drug appeared in the USSR in 1984 and became widely known in the medical community of the country. Currently, Actovegin® is manufactured in the company’s plants in Linz city (Austria), Oranienbaum (Germany) and Yaroslavl (Russia). The drug is registered in 22 world’s countries, including the countries of CIS, European Union (Austria, Latvia, Romania), a number of Asian countries, where it’s effectively used.
Takeda is a Japanese pharmaceutical company entering the world’s 15 largest companies. Over 29 thousand of people are working for Takeda Pharmaceutical all over the world. The company’s area of interest: cardiovascular and oncological diseases, gastroenterology, respiratory diseases and immunology, neurology.
INDICATIONS FOR USE:
Actovegin® is a deproteinized ultrafiltrate of calf blood, containing over 200 biological substances. The drug is most often used in clinical practice in ischemic and metabolic brain damage, including stroke, encephalopathy of various genesis, as well as in the disorders of peripheral arterial and venous perfusion, diabetic polyneuropathy.
Preclinical studies showed that the use of Actovegin® on the molecular level improves the oxygen and glucose uptake and capture by cells that results in the strengthening of the cell’s energy metabolism and the increase in adenosine triphosphoric acid products.
It was established in experimental works that Actovegin® has a safe neuroprotective action: it increases the number of survived neutrons, synaptic contacts, decreases the production of the free radicals of oxygen, suppresses apoptosis processes, decreasing the activity level of caspase-3.
Besides, Actovegin® improves microcirculation in tissues, having a positive effect on the endothelium of vessels. The mechanisms providing the neuroprotective and metabolic action of the drug define its effectiveness in various diseases and conditions, including stroke, the manifestation of chronic cerebral ischemia, diabetic polyneuropathy.
The modern tendencies of the medical science in the Republic of Kazakhstan based on international principles of evidence-based medicine place quite severe demands on the studies, which confirm the effectiveness and safety of used medicines. The Cochrane library and the PubMed (Medline) database are some of the most reliable sources where one can find out more about with significant researches on one or another medical product (technologies, treatment method).
Currently, 48 Actovegin® publications are included in the Cochrane library, and 137 publications in the PubMed database. For example, “Actovegin in dementia” systematic review (John Donoghue, School of Pharmacy and Biosciences John Mooves University,Liverpool, UK) has 1A level of evidence; “Actovegin in comparison with placebo in diabetic polyneuropathy patients” multicentral randomized double blind placebo-controlled study. (Ziegler D., Movsesyan L., Mankovsky B. et al. Treatment of symptomatic polyneuropathy with Аctovegin in type 2 diabetic patients. Diabetes Care 2009) – 1B level of evidence.)
In April 2017, the findings of the ARTEMIDA study (a 12-month international, randomized, multi-central, double blind, placebo-controlled study in parallel groups), where the effectiveness and safety of the Actovegin were assessed for post apoplectic cognitive impairments (PACI) treatment, was published in the most reputable journal Stroke. Stroke is a peer-reviewed medical journal, being the official printed issue of the American Heart and Stroke Association (AHA/ASA). The journal ranks the 13th among 192 journals in the Clinical Neurology category.
Based on the ARTEMIDA research findings, Actovegin produced a beneficial effect onthe cognitive functions of patients with PACI. 503 patients from 33 medical institutions in Russia, Belarus, Kazakhstan took part in this study. The study included a period of screening and randomization (≤7 days after stroke), a 6-month period of double blind treatment and a 6-month follow-up period.
The patients were randomized into 2 groups: 1 st – took Actovegin (0,9% NaCl, 2000 mg/250 ml to 20 infusions every day, then 1200 mg/day p.o.), 2 nd – placebo within 6 months. Upon completion of this period, the therapy was stopped, and the follow-up period lasted within next 6 months.
The primary endpoint was the change of cognitive functioning in the groups assessed on the ADAS-Cog+ scale in 6 months after the therapy beginning in comparison with initial values. The ADAS-Cog+ - generally accepted scale (consists of 11 subtests for assessing various cognitive functions, such as memory, speech, visuospatial functions and a number of others) is widely used in clinical studies and makes it possible to observe the dynamics of cognitive functions in patients with Alzheimer's disease. The secondary endpoints of cognitive functions were changes on the ADAS-Cog+ scale in 3 and 12 months, the number of respondents on the ADAS-Cog+ scale (improvement by 4 and more scores), as well as changes on the MoCA (the Montreal scale of cognitive function assessment) scale from initial values in 3, 6 and 12 months.
In 6 months of treatment a statistically significant difference regarding the primary endpoint, which was preserved even after the cessation of therapy within the next 6 months of follow-up, was obtained. The similar results were obtained regarding the MoCAscale. Moreover, a statistically significant difference in favor of Actovegin was observed already after 3 months of therapy. It impresses that the number of patients with the “dementia” diagnosis by the end of the study in the group taking Actovegin was 30% less than in the placebo group. The frequency of developing adverse events developed throughout the treatment period was similar in both groups.
“The findings of the ARTEMIDA research give us ground to include the Actovegin® drug to a very narrow cohort of medicines with an extensive evidential base in regard to cognitive disorders”, believes Vladimir Zakharov M.D., Professor of Nervous Disease Department of Sechenov First Moscow State Medical University, one of the main researchers of ARTEMIDA.