Possibilities of using Meldonium Organica in the combination treatment of cardiovascular and cerebrovascular diseases

DOI: https://doi.org/10.29296/25877305-2019-09-06
Issue: 
9
Year: 
2019

T. Potupchik(1), Candidate of Medical Sciences; L. Evert(2), MD; O. Averyanova(3); Yu. Akhmeldinova(1); A. Ivanov(1) 1-Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University 2-Research Institute for Medical Problems of the North, Federal Research Center «Krasnoyarsk Research Center, Siberian Branch, Russian Academy of Sciences» 3-Krasnoyarsk Interdistrict Maternity Hospital Four

The paper reviews clinical studies of Meldonium, which have shown its efficacy in treating cardiovascular diseases. Meldonium is widely used in the combination therapy of coronary heart disease, chronic heart failure, and acute and chronic cerebrovascular diseases. The authors describe the results of a bioequivalence study of Meldonium Organica 500 mg capsules (AO «Organika», Russia) and Mildronat®, 500 mg capsules (AO «Grindex», Latvia), according to the data of which the drugs are bioequivalent, which suggests that Meldonium Organica may be used in clinical practice.
Keywords: 
cardiology
neurology
Meldonium Organica
mildronate
cytoprotection
cardiovascular diseases

References: 
  1. Abdullaev A.A., Magomedova A.D., Islamova U.A. i dr. Effektivnost' mel'donija v umen'shenii elektricheskoj nestabil'nosti serdtsa u patsientov s ishemicheskim insul'tom // Rats. farmakoter. v kardiol. 2014; 10 (1): 43–8 [Abdullayev A.A., Magomedova A.D., Islamova U.A. et al. The Effectiveness of Meldonium in reducing electrical instability of the heart in patients with ischemic stroke // Rational Pharmacotherapy in Cardiology. – 2014; 10 (1): 43–8 (in Russ.)]. DOI: 10.20996/1819-6446-2014-10-1-43-48.
  2. Artjushkova E.V. Uvelichenie urovnja gamma-butirobetaina – farmakologicheskaja mishen' dlja korrektsii endotelial'noj disfunktsii // Kubanskij nauchnyj meditsinskij vestnik. – 2009; 4: 72–4 [Artyushkova E.V. Increased levels of gamma-butyrobetaine – pharmacological target for the correction of endothelial dysfunction // Kuban Medical Science Bulletin. – 2009; 4: 72–4 (in Russ.)].
  3. Belovol A.N., Knjaz'kova I.I. Perspektivy farmakologicheskoj korrektsii gipoksii v kardionevrologii i nevrologii // Lіki Ukraїni. – 2009; 2 (128): 65–72 [Belovol A.N., Knyazkova I.I. Prospects for pharmacological correction of hypoxia in kardionevrologii and neurology // Liky of Ukraine. – 2009; 2 (128): 65–72 (in Ukrainian)].
  4. Voronkov L.G., Shkurat I.A., Lutsak E.A. Vlijanie mildronata na endotelijzavisimuju vazodilatatsiju u bol'nyh hronicheskoj serdechnoj nedostatochnost'ju: dvojnoe slepoe perekrestnoe issledovanie // Rats. farmakoter. – 2008; 2: 38–40 [Voronkov L.G., Shkurat I.A., Lutsak E.A. Mildronat influence on endothelialdependent vasodilaton in patients with chronic heart failure: doubleblind crossed placeb trial // Rational Pharmakotherapy. – 2008; 2: 38–40 (in Russ.)].
  5. Galjavich A.S., Galeeeva Z.M., Baleeva L.V. Effektivnost' i bezopasnost' mildronata pri lechenii hronicheskoj serdechnoj nedostatochnost'ju // Ros. kardiol. zhurn. – 2005; 5 (55): 55–9 [Galyavich A.S., Galeeva Z.M., Belyaeva L.V. Efficacy and safety of Mildronate in the treatment of chronic heart failure // Rus. Cardiol. J. – 2005; 5 (55): 55–9 (in Russ.)].
  6. Gordeev I.G., Luchinkina E.E., Ljusov V.A. Antioksidantnyj effekt kardioprotektora mildronata u patsientov, podvergshihsja koronarnoj revaskuljarizatsii // Ros. kardiol. zhurn. – 2009; 1 (75): 31–7 [Gordeev I.G., Luchinkina E.E., Lysov V.A. Antioxidant effect of cardioprotection of Mildronate in patients undergoing coronary revascularization // Russ. Cardiol. J. – 2009; 1 (75): 31–7 (in Russ.)].
  7. Gordeev I.G., Taratuhin E.O. «Lechit' ne bolezn', no bol'nogo»: Mildronat kak sredstvo kompleksnoj terapii serdechno-sosudistoj patologii // Kardiovask. ter. i profilakt. – 2013; 12 (3): 95–8 [Gordeev I.G., Taratukhin E.O. «To treat not a disease, but a patient»: Mildronate as a means of complex therapy of cardiovascular pathology // Cardiovascular therapy and prevention. – 2013; 12 (3): 95–8 (in Russ.)].
  8. Damulin I.V., Koberskaja N.N., Antonenko L.M. Vlijanie Mildronata na kognitivnye narushenija pri distsirkuljatornoj entsefalopatii: kliniko-elektrofiziologicheskoe issledovanie // Nevrol. zhurn. – 2006; A(1): 1–6 [Damulin I.V., Kuberskaya N.N., Antonenko L.M. Influence of Mildronate on cognitive disorders in dyscirculatory encephalopathy: clinical and electrophysiological study // Neurol. J. – 2006; A(1): 1–6 (in Russ.)].
  9. Dzerve V.Ja., Pozdnjakov Ju.M. Dinamika tolerantnosti k fizicheskoj nagruzke u patsientov s ishemicheskoj bolezn'ju serdtsa i perifericheskoj bolezn'ju arterij na fone dlitel'noj terapii mildronatom // Ros. kardiol. zhurn. – 2011; 1 (87): 49–55 [Dzerve V.Ya., Pozdnjakov Yu.M. Dynamic of exercise tolerance in patients with coronary heart disease during long-term mildronate treatment // Russ. Cardiol. J. – 2011; 1 (87): 49–55 (in Russ.)].
  10. Dzjak L.A., Golik V.A. Primenenie Mildronata pri lechenii bol'nyh distsirkuljatornoj entsefalopatiej na fone stenozirujuschego porazhenija magistral'nyh arterij golovy // Vrachebnoe delo. – 2003; 5–6: 98–101 [Dzyak L.A., Kalik V.A. the Use of Mildronate in the treatment of patients with dyscirculatory encephalopathy on the background of stenosing lesions of the main arteries of the head // Medical practice. – 2003; 5–6: 98–101 (in Russ.)].
  11. Isakov E.B. Epidemiologija serdechno-sosudistyh zabolevanij // Meditsina i ekologija. – 2017; 2: 19–27 [Isakov E.B. Epidemiology of cardiovascular diseases // Medicine and Ecology. – 2017; 2: 19–27 (in Russ.)].
  12. Kalvin'sh I., Visokinskas A., Bogdanas G. Primenenie mildronata v geriatrii u patsientov s serdechnoj nedostatochnost'ju // Ter. arh. – 2006; 9: 75–7 [Kalvins I., Visokinskas A., Bogdanas G. Application of mildronat in geriatric patients with heart failure // Ther. Arch. – 2006; 9: 75–7 (in Russ.)].
  13. Klochihina O.A., Stahovskaja L.V. Analiz epidemiologicheskih pokazatelej insul'ta na osnovanii dannyh territorial'no-populjatsionnogo registra 2009–2012 gg. // Zhurn. nevrol. i psihiat. im. S.S. Korsakova. – 2014; 6: 63–9 [Klochihin O.A., Stakhovskaya L.V. Analysis of epidemiological indices of stroke on the basis of territorial-population registry 2009–2012 // S.S. Korsakov J. Neurol. psychiat. – 2014; 6: 63–9 (in Russ.)].
  14. Kononov S.K., Solov'ev O.V., Onuchina E.L. i dr. Effektivnost' ispol'zovanija Mildronata v terapii fibrilljatsii predserdij u patsientov s metabolicheskim sindromom // Sovremennye tehnologii v meditsine. – 2011; 3: 50–9 [Kononov, S.K., Soloviev O.V., Onuchina E.L. et al. The effectiveness of the use of Mildronate in the treatment of atrial fibrillation in patients with metabolic syndrome // Modern technologies in medicine. – 2011; 3: 50–9 (in Russ.)].
  15. Logunova L.V. Novye aspekty v ispol'zovanii mildronata dlja profilaktiki i korrektsii narushenij adaptatsionnyh protsessov // Vestnik RUDN (serija Meditsina). – 2009; 1: 81–8 [Logunova L.V. New aspects in the use of Mildronate for the prevention and correction of violations of adaptation processes // Vestnik RUDN (series Meditsina), – 2009; 1: 81–8 (in Russ.)].
  16. Maksimova M.Ju., Kistenev B.A., Domashenko M.A. i dr. Klinicheskaja effektivnost' i antioksidantnaja aktivnost' Mildronata pri ishemicheskom insul'te // Ros. kardiol. zhurn. – 2009; 4 (78): 54–62 [Maksimova M.Yu., Kistenev B.A., Domashenko M.A. et al. Clinical efficacy and antioxidant activity mildronata in ischemic stroke // Rus. Cardiol. J. – 2009; 4 (78): 55–63 (in Russ.)].
  17. Mihin V.P., Pozdnjakov Ju.M., Hlebodarov F.E. i dr. Mildronat v kardiologicheskoj praktike – itogi, novye napravlenija, perspektivy // Kardiovask. ter. i profilakt. – 2012; 11 (1): 96–103 [Mihin V.P., Pozdnjakov Y.M., Hlebodarov F.E. et al. Mildronat in cardiology practice – the results, new directions and perspectives // Cardiovascular therapy and the prevention. – 2012; 11 (1): 96–103 (in Russ.)].
  18. Napalkov D.A., Zhilenko A.V. Tsitoprotektsija v kardiologii: mif ili real'nost'? // Farmateka. – 2013; 6: 111–5 [Napalkov D.A., Zhilenko A.V. Cytoprotection in cardiology: myth or reality? // Pharmateca. – 2013; 6: 111–5 (in Russ.)].
  19. Pizova N.V. Opyt primenenija mildronata pri tserebrovaskuljarnyh zabolevanijah // Med. sovet. – 2015; 5: 14–7 [Pisova N.V. Experience in the use of Mildronate in cerebrovascular diseases // Medical Council. – 2015; 5: 14–7 (in Russ.)]. DOI: 10.21518/2079-701X-2015-5-14-18.
  20. Ponomarev V.V., Homichenko T.V., Krjukova O.V. Effektivnost' mildronata v lechenii patsientov s hronicheskoj sosudistoj mozgovoj nedostatochnost'ju // Med. novosti. – 2013; 1: 51–4 [Ponomarev V.V., Khomchenko T.V., Kryukova O.V. the Effectiveness of Mildronate in the treatment of patients with chronic cerebrovascular insufficiency // Medical news. – 2013; 1: 51–4 (in Russ.)].
  21. Romanenko A.A. Vlijanie mildronata «Mel'donija» na vosstanovitel'nyj protsess posle fizicheskoj nagruzki // Mezhdunarodnyj zhurnal prikladnyh i fundamental'nyh issledovanij. – 2016; 11 (4): 763–5 [Romanenko A.A. Influence of Mildronate «Meldonium» on the recovery process after physical activity // International Journal of Applied and Fundamental Research. – 2016; 11 (4): 763–5 (in Russ.)].
  22. Samorodskaja I.V. Mel'donij: obzor rezul'tatov issledovanij // Ros. med. zhurn. – 2013; 36: 1818. [Samorodskaya I.V. Meldonium: review of research results // Rus. Med. J. – 2013; 36: 1818. (in Russ.)].
  23. Statsenko M.E., Belenkova S.V., Sporova O.E. i dr. Primenenie mildronata v kombinirovannoj terapii hronicheskoj serdechnoj nedostatochnosti v postinfarktnom periode u bol'nyh saharnym diabetom 2-go tipa // Klin. meditsina. – 2007; 7: 39–42 [Statsenko M.E., Belenkova S.V., Sporova O.E. et al. The Use of Mildronate in the combined therapy of chronic heart failure in the post-infarction period in patients with type 2 diabetes // Clinical medicine. – 2007; 7: 39–42 (in Russ.)].
  24. Statsenko M.E., Poletaeva L.V., Gurkina S.V. i dr. Klinicheskaja effektivnost' mildronata v kompleksnom lechenii diabeticheskoj perifericheskoj (sensomotornoj) nejropatii // Klin. meditsina. – 2008; 9: 67–71 [Statsenko M.E., Poletaeva L.V., Gurkina S.V. et al. Clinical efficacy of Mildronate in complex treatment of diabetic peripheral (sensorimotor) neuropathy // Clinical medicine. – 2008; 9: 67–71 (in Russ.)].
  25. Statsenko M.E., Starkova G.V., Govoruha O.A. i dr. Vozmozhnosti primenenija mildronata v kompleksnom lechenii hronicheskoj serdechnoj nedostatochnosti v rannem postinfarktnom periode // Ros. kardiol. zhurn. – 2005; 6 (56): 62–6 [Statsenko M.E., Starkova G.V., Govorukha O.A. et al. The Possibility of using Mildronate in the complex treatment of chronic heart failure in the early postinfarction period // Rus. Cardiol. J. – 2005; 6 (56): 62–6 (in Russ.)].
  26. Statsenko M.E., Turkina S.V., Belenkova S.V. i dr. Vlijanie mildronata v sostave kombinirovannoj terapii hronicheskoj serdechnoj nedostatochnosti u bol'nyh saharnym diabetom tipa 2 na uglevodnyj, lipidnyj obmen i pokazateli oksidativnogo stressa // Ros. kardiol. zhurn. – 2010; 2: 45–51 [Statcenko M.E., Turkina S.V., Belenkova S.V. et al. Influence mildronata comprising combination therapy of chronic heart failure in patients with type 2 diabetes on carbohydrate and lipid metabolism and oxidative stress indicators // Rus. Cardiol. J. – 2010; 2: 45–51 (in Russ.)].
  27. Suslina Z.A., Maksimova M.Ju., Kistenev B.A. i dr. Nejroprotektsija pri ishemicheskom insul'te: effektivnost' mildronata // Mezhdunar. nevrol. zhurn. – 2012; 3 (49): 94–8 [Suslina Z.A., Maksimova M.Yu., Kistenev B.A. et al. Neuroprotection in ischemic stroke: effectiveness of Mildronate // International Neurological Journal. – 2012; 3 (49): 94–8 (in Russ.)].
  28. Suslina Z.A., Maksimova M.Ju., Kistenev B.A. i dr. Antioksidantnaja terapija u bol'nyh distsirkuljatornoj entsefalopatiej, otjagoschennoj saharnym diabetom tipa 2 // Farmateka. – 2005; 12: 68–70 [Suslina Z.A., Maksimova M.Yu., Kistenev B.A. et al. Antioxidant therapy in patients with dyscirculatory encephalopathy burdened with type 2 diabetes mellitus // Pharmateca. – 2005; 12: 68–70 (in Russ.)].
  29. Hasenova G.P., Kajshibaev N.S., Kajshibaeva G.S. i dr. Effektivnost' primenenija preparata Mildronat u bol'nyh s distsirkuljatornoj entsefalopatiej ateroskleroticheskogo geneza // Mezhdunar. nevrol. zhurn. – 2012; 7 (53): 87–93 [Khasenova G.P., Kishibaev N.S, Kishibaev G.S. et al. Efficacy of Mildronate in patients with discirculatory encephalopathy of atherosclerotic Genesis // International Neurological Journal. – 2012; 7 (53): 87–93 (in Russ.)].
  30. Eninja G.I., Timofeeva T.N., Egere D.A. i dr. Lechebnye effekty Mildronata i pokazanija k ego primeneniju v nejroangiologii // Eksperim. i klin. farmakoter. (Riga, Zinatne). – 1991; 19: 164–71 [Anina G.I., Timofeeva T.N., Eger D.A. et al. Therapeutic effects of Mildronate and indications for its use in neuroangiography // Experim. Clin. Pharmacother. (Riga, Zinatne). – 1991; 19: 164–71 (in Russ.)].
  31. A Dose-Dependent Improvement in Exercise Tolerance in Patients With Stable Angina Treated With Mildronate: A Clinical Trial «MILSS I» VilnisDzerve, MILSS I Study Group // Medicina (Kaunas). – 2011; 47 (10): 544–51.
  32. Dzerve V. MILSS I Study Group. A dose-dependent improvement in exercise tolerance in patients with stable angina treated with mildronate: a clinical trial «MILSS I» // Medicina (Kaunas). – 2011; 47 (10): 544–51.