THE PROBLEM OF INTERCHANGEABILITY OF DRUG PRODUCTS. TRIMETAZIDINE IS AN EFFECTIVE TREATMENT OF PATIENTS WITH ISCHEMIC HEART DISEASE
https://doi.org/10.20996/1819-6446-2012-8-4-515-520
Abstract
Aim. To study the possibility of enhancing the antianginal effect of long-acting nitrates by their combination with trimetazidine in patients with stable angina. Material and methods. Patients with ischemic heart disease (IHD, stable angina; n=55) were included into the study. Patients were randomized to receive trimetazidine 35 mg 2 times a day (intervention group) or placebo (control group) in addition to standard therapy. A daily number of angina attacks, amount of short-acting nitroglycerin tablets consumed per week, exercise tolerance by the bicycle ergometry with the calculation of the threshold power and the work capacity were assessed at baseline and after 2 months of the drugs taking, as well as 2 months after the drugs withdrawal. Results. Significant reduction in nitroglycerin tablets consumption (1 month — by 61.8%, after 2 months — 72.5%, p<0.05) were found in the intervention group compared with the control group. Low intake of nitroglycerin compared with baseline (p<0.05) was maintained for 2 months after discontinuation of study drug. Significant increase in the threshold power (1 month — by 32.3%, after 2 months — 37.5%, p<0.05) was observed in the intervention group compared to baseline and with the control group. Conclusion. Trimetazidine in the treatment of stable angina has high clinical efficacy.
About the Authors
L. E. Chekuldaeva
Medical Care Unit №2, Samara
Russian Federation
Russian Federation
S. V. Obuhova
Medical Care Unit №2, Samara
Russian Federation
Russian Federation
A. A. Simakov
Samara Medical Institute "Reaviz"
Russian Federation
Russian Federation
L. V. Poljaeva
Medical Care Unit №2, Samara
Russian Federation
Russian Federation
E. I. Rjazanova
Medical Care Unit №2, Samara
Russian Federation
Russian Federation
References
1. Dorofeev V.L. Approaches to assessing the interchangeability of medicines. Remedium 2011; 12: 51–57. Russian (Дорофеев В.Л. Подходы к оценке взаимозаменяемости лекарственных средств. Ремедиум 2011; 12: 51–57).
2. National guidelines for cardiovascular prevention. Kardiovaskuljarnaja Terapija i Profilaktika 2011; 10(6) suppl 2: 1–24. Russian (Национальные рекомендации по кардиоваскулярной профилактике. Кардиоваскулярная терапия и профилактика 2011; 10 (6) Приложение 2: 1–24).
3. Kosarev V.V., Babanov S.A. Clinical features of modern pharmacology cytoprotectors. Russkij Medicinskij Zhurnal 2011; 26:1619–22. Russian (Косарев В.В., Бабанов С.А. Особенности клинической фармакологии современных цитопротекторов. РМЖ 2011; 26:1619–22).
4. Kantor P., Lucien A., Kozak R. et al. The antianginal drug trimetazidine shifts cardiac energy metabolism from fatty acid oxidation to glucose oxidation by inhibiting mitochondrial long-chain 3-ketoacyl coenzyme A thiolase. Circulation Res 2000; 17: 580–588.
5. Fox K., Garcia M.A., Ardissino D. et al. Guidelines on the management of stable angina pectoris — executive summary. The Task Force on the Management of stable angina pectoris of the European Society of Cardiology. Eur Heart J 2006; 27: 1341–1381.
6. National guidelines for diagnosis and treatment of stable angina. Kardiovaskuljarnaja Terapija i Profilaktika 2008; 7(6) suppl 4: 1–42. Russian (Национальные рекомендации по диагностике и лечению стабильной стенокардии. Кардиоваскулярная Терапия и Профилактика 2008; 7(6) Приложение 4: 1–42).
7. Nedogoda S.V., Petrov V.I. Evidence-based medicine and medical advertising. Spravochnik Poliklinicheskogo Vracha 2010; (12): 3–8. Russian (Недогода С.В., Петров В.И. Доказательная медицина и медицинская реклама. Справочник Поликлинического Врача 2010; (12): 3–8).
8. Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series 2006; 937 Annex 7: 347–90.
9. Approved Drug Products with Therapeutic Equivalence Evaluations, 32nd ed., FDA, 2012. Available on: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm 071436.pdf. Date of access: 23/08/2012.
10. Marcevich S.Ju., Kutishenko N.P., Deev A.D. Original drugs and generic drugs in cardiology. Can you solve the problem of interoperability? Vestnik Roszdravnadzora 2009; (4): 48–51. Russian (Марцевич С.Ю., Кутишенко Н.П., Деев А.Д. Оригинальные препараты и дженерики в кардиологии. Можно ли решить проблему взаимозаменяемости? Вестник Росздравнадзора 2009; (4): 48–51).
11. Martsevich S.Yu., Kutishenko N.P., Ginzburg M.L. et al. The KARDIOKANON study: a way to settle the subject of clinical equivalence of generic and original drugs. Rational Pharmacother Card 2012;8(2):179–184. Russian (Марцевич С.Ю, Кутишенко Н.П., Гинзбург М.Л., и др. Исследование КАРДИОКАНОН: способ решения вопроса о клинической эквивалентности оригинальных и воспроизведенных препаратов. РФК 2012;8(2):179–184).
12. Zhang L., Lu Y., Jiang H. et al. Additional Use of Trimetazidine in Patients With Chronic Heart Failure. A Meta-Analysis. J Am Coll Cardiol 2012;59;913–22.
13. Feelisch M. Biotransformation of organic nitrates to nitric oxide by vascular smooth muscle cells and endothelial cells. Biochem Biophys Commun 1991; 180: 286–293.
Review
For citations:
Chekuldaeva L.E., Obuhova S.V., Simakov A.A., Poljaeva L.V., Rjazanova E.I. THE PROBLEM OF INTERCHANGEABILITY OF DRUG PRODUCTS. TRIMETAZIDINE IS AN EFFECTIVE TREATMENT OF PATIENTS WITH ISCHEMIC HEART DISEASE. Rational Pharmacotherapy in Cardiology. 2012;8(4):515-520. (In Russ.) https://doi.org/10.20996/1819-6446-2012-8-4-515-520
Views: 636
Email this article 