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THE KARDIOKANON STUDY: A WAY TO SETTLE THE SUBJECT OF CLINICAL EQUIVALENCE OF GENERIC AND ORIGINAL DRUGS

https://doi.org/10.20996/1819-6446-2012-8-2-54-55

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Abstract

Aim. To compare two therapies based on the use of original or generic drugs in patients with stable ischemic heart disease (IHD). Material and methods. Patients (n=120), aged 40–72 (58.7±7.7) years, 93 men and 27 women, with stable angina, functional class (FC) II (n=117, 97.5%) and III (n=3, 2.5%), were included in the multi-center open randomized study with parallel groups. Patients were randomized into 2 groups: group 1 (n=59) received therapy with original drugs only , and group 2 (n=61) — with generics ones only. Efficacy of the therapies was evaluated by the rate of achievement of target blood pressure (BP<130/80 mm Hg), heart rate (HR=55–60 beat per minute) and cholesterol of low density lipoprotein (LDL<70 mg% or 1.8 mmol/l), as well as by the degree of reduction in the angina attacks rate, the need in short-acting nitrates, and the angina FC. Treatment duration was 12 weeks. Results. After randomization both groups of patients were comparable by the main clinical indicators. The rates of target levels achievement were the following in group 1 vs group 2, respectively: for BP - 54 vs 44%, p=0.08; for HR - 51 vs 53%, р=0.66; LDL cholesterol - 27.7 vs 9.9% of patients, p=0.002. There were no significant differences between original and generic drugs effects on the angina pectoris symptoms dynamics, as well as their influence on glucose, bilirubin, creatinine, alanine and asparagine transaminases, and creatine phosphokinase blood levels dynamics. The original and generic drugs prescription rates, a total number of prescribed drugs and prescribed doses were comparable in both groups at the end of the study. Three patients dropped out of the trial, the frequency of adverse events was 3.4% in group 1 and 11.5% — in group 2 (p=0.09). Conclusion. Generic drugs with proven bioequivalence, used in the KARDIOKANON study , demonstrated their clinical equivalence to original drugs. The use of these drugs in patients with stable IHD may provide efficacy and quality of therapy comparable with these in original drugs.

About the Authors

S. Yu. Martsevich
State Research Center for Preventive Medicine I.M. Setchenov First Moscow State Medical University
Russian Federation


N. P. Kutishenko
State Research Center for Preventive Medicine I.M. Setchenov First Moscow State Medical University
Russian Federation


M. L. Ginzburg
Lyubertsy Regional Hospital №2
Russian Federation


G. V. Matyushin
Krasnoyarsk State Medical University named after V.F . Voyno-Yasenetsky
Russian Federation


V. V. Skibitskiy
Kuban State Medical University
Russian Federation


L. A. Sokolova
St.-Petersburg State Medical Academy named after I.I. Mechnikov
Russian Federation


A. V. Deev
State Research Center for Preventive Medicine
Russian Federation


References

1. Российский статистический ежегодник 2010. Москва 2010.

2. Volpe M., Alderman M, Furberg C. et al. Beyond hypertension. Toward guide-lines for cardiovascular risk reduction. Am J Hypertens 2004; 17: 1068–1074.

3. Staessen JA, Wang J-G, Thijs L. Cardiovascular prevention and blood pressure reduction: a quantitative overview updated until 1 March 2003. J Hypertens 2003; 21: 1055–76.

4. Pahor M., Psaty В.М., Alderman M.H. et al. Health outcomes associated with calcium antagonists compared with other first-line anlihypertensive therapies: a meta-analysis of randomised controlled trials. Lancet 2000; 356: 1949–1954.

5. National guidelines for a rational pharmacotherapy of patients with cardiovascular diseases. Available on: http://www.scardio.ru/downloads/c4m0i257/recomendacii.doc. Russian Национальные рекомендации по рациональной фармакотерапии больных сердечно-сосудистыми заболеваниями. Доступно на: http://www.scardio.ru/downloads/c4m0i257/recomendacii.doc

6. Guidelines for the Management of Patients With Chronic Stable Angina. J Am Coll Cardiol 2007; 50:2264.

7. ESC guidelines y 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.

8. Johonston A., Stafylas P , Stergiou GS. Effectiveness, safety and cost of drug substitution in hypertension. Br J Clin Pharmacol 2010; 70(3): 320–334.

9. Белоусов Ю.Б. Дженерики — мифы и реалии. Ремедиум 2003; 7–8: 4–9.

10. Кутишенко Н.П., Марцевич С.Ю., Вашурина И.В. Что такое терапевтическая эквивалентность (дженерика) и как ее доказать. РФК 2011; 7(2): 241–245.


For citation:


Martsevich S.Yu., Kutishenko N.P., Ginzburg M.L., Matyushin G.V., Skibitskiy V.V., Sokolova L.A., Deev A.V. THE KARDIOKANON STUDY: A WAY TO SETTLE THE SUBJECT OF CLINICAL EQUIVALENCE OF GENERIC AND ORIGINAL DRUGS. Rational Pharmacotherapy in Cardiology. 2012;8(2):179-184. (In Russ.) https://doi.org/10.20996/1819-6446-2012-8-2-54-55

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ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)