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COMPARISON OF EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC DRUGS OF SIMVASTATIN IN PATIENTS WITH HYPERLIPIDAEMIA AND HIGH RISK OF ISCHEMIC HEART DISEASE COMPLICATIONS

https://doi.org/10.20996/1819-6446-2008-4-5-23-27

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Abstract

Aim. To assess efficacy and safety of generic simvastatin, Simvahexal, in comparison with original drug of simvastatin, Zocor, in patients with hyperlipidaemia in short-term study.

Material and methods. 30 patients (19 men and 11 women, 64,0±1,8 y.o.) with low density lipoprotein (LDL) cholesterol ≥3,0 mmol/l and high cardiovascular risk were involved into the study. During 5 weeks before study including patients kept the hypolipidaemic diet and did not receive any hypolipidaemic drug. 28 patients completed study, 2 patients drop out: one patient because of nettle rash on Zocor therapy, another one – because of personal reason. Efficacy was assessed by dynamic of lipid profile and a number of patients who reached target level of LDL cholesterol (<3 mmol/l). Safety was assessed by side effect rate registration. Patients were randomized in 2 groups (G1 and G2): G1 patients (n=15) received Zocor 20 mg/day during 6 weeks, G2 patients (n=15) – Simvahexal 20 mg/day. After 6 weeks of therapy G1 patients were switched from Zocor to Simvahexal, G2 patients did not change their therapy. Simvahexal dose was increased to 30 mg/day, if the target level of LDL cholesterol had not been reached after first 6 weeks of therapy.

Results. After switching therapy from Zocor to Simvahexal 11 patients increased the dose to 30 mg/day, 3 patients kept the dose of 20 mg/day, 1 patient drop out. At the beginning of the study 15 patients received Simvahexal 20 mg/day, after 6 weeks the dose was increased to 30 mg/day in 8 patients, 7 patients kept the dose of 20 mg/day. After 6 weeks of therapy with Zocor 20 mg/day levels of the total cholesterol (TC) and LDL cholesterol reduced on 25,2% and 33,6% (p<0,001), respectively. Next 6 weeks of therapy with Simvahexal in the average dose of 27,7 mg/day this reduction reached to 30,9% and 39,9% (p<0,001), respectively. After 6 weeks of therapy with Simvahexal 20mg/day levels of the TC and LDL cholesterol reduced on 28,2%and 38%(p<0,001), respectively. Next 6weeks of therapywith Simvahexal in the average dose of 25,3mg/day this reduction reached to 29,6%and 42,5%(p<0,001), respectively. In G1 patients Zocor 20mg/day reduced atherogenesis index (AI) from5,2 to 3,3 (p<0,001) after 6weeks of therapy. Next 6weeks of therapywith Simvahexal in the average dose of 27,7mg/day this reduction reached to 3,1. In G2 patients AIwas reduced from4,1 to 2,4 (p<0,001) after first 6 weeks of therapy with Simvahexal 20 mg/day and remained at the same level during next 6 weeks of therapy. Both drugs were comparable in rate (6 cases for each) and intensity of side effects. Slight increase (in the normal range) of creatine kinaze, alanine aminotransferase and aspartate aminotransferase levels was observed during both therapies, but a little bit more prominent in Simvahexal one.

Conclusion. Simvahexal, is comparable with Zocor in terms of hypolipidaemic effect in 6-week therapy.We consider Simvahexal® as a generic therapeutically equivalent to original simvastatin drug.

About the Authors

S. N. Tolpygina
State Research Center of Preventive Medicine of Rosmedtechnology, Petroverigsky per. 10, Moscow, 101990 Russia
Russian Federation


S. Y. Martsevich
State Research Center of Preventive Medicine of Rosmedtechnology, Petroverigsky per. 10, Moscow, 101990 Russia
Russian Federation


References

1. Диагностика и коррекция нарушений липидного обмена с целью профилактики и лечения атеросклероза. Российские рекомендации. Кардиоваскулярная терапия и профилактика 2004;2 (приложение):1-18.

2. Tonkin A.M. Clinical relevance of statins: their role in secondary prevention. Atheroscler Suppl. 2001;2(1):21–5.

3. Courville K.A., Lavie C.J., Milani R.V. Lipid-lowering therapy for elderly patients at risk for coronary events and stroke. Am Heart Hosp J. 2005;3(4):256–62.

4. Eberly L.E., Neaton J.D., Thomas A.J. et al. Multiple-stage screening and mortality in the Multiple Risk Factor Intervention Trial. Clin Trials. 2004;1(2):148–61.

5. Marchioli R, Tognoni G. Beneficial effects of statins. GISSI-Prevenzione Investigators. Lancet 1996;348:1582.

6. Grines C.L. The role of statins in reversing atherosclerosis: what the latest regression studies show. J Interv Cardiol. 2006;19(1):3–9.

7. van Boven A.J., Brugemann J., de Graeff P.A. et al. The 4S study. Implications for prescribing. Drugs. 1996;51(4):507–14.

8. West of Scotland Coronary Prevention Study: identification of high-risk groups and comparison with other cardiovascular intervention trials. Lancet. 1996; 348(9038):1339–42.

9. Haffner S.M. The Scandinavian Simvastatin Survival Study (4S) subgroup analysis of diabetic subjects: implications for the prevention of coronary heart disease. Diabetes Care. 1997;20(4):469–71.

10. Белоусов Ю.Б. Дженерики – мифы и реалии. Remedium. 2003.(7–8):4–9.

11. Кухарчук В.В., Бубнова М.Г., Кательницкая Л.И. и др. Эффективность и безопасность симвастатина у пациентов с гиперхолестеринемией (результаты многоцентрового клинического исследования). Кардиология 2003;(5):42–7.

12. Сусеков А.В., Соловьева Е.Ю., Рожкова Т.А. и др. Симвастатин (Зокор) 20 мг и ловастатин (Холетар) 40 мг у больных ИБС и первичной гиперхолестеринемией: исследование эквивалентности доз. Клин фармакол тер 2001;(4):57-61.

13. Беркович О.А., Беляева О.Д., Баженова Е.А., и др. Влияние статинов на функциональное состояние эндотелия сосудов у больных ишемической болезнью сердца. РМЖ 2002;10(19):874-7.

14. Либов И.А., Гультикова О.С., Милешникова Т.Д., и др. Необходимость и возможность расширения применения статинов в кардиологической практике. РМЖ 2002;10(10):458-61.

15. Абраменко Л.И., Баженова Е.А., Беляева О.Д., и др. Влияние статинов на функциональное состояние эндотелия сосудов у больных ишемической болезнью сердца. РМЖ 2002;10(19):874-77.

16. Stein EA, Lane M, Laskarzewski P. Comparison of statins in hypertriglyceridemia. Am J Cardiol 1998;81(4A):66B-69B.

17. Марцевич С.Ю, Перова Н.В, Кутишенко Н.П. и др. Открытое клиническое исследование эффективности и безопасности нового дженерика симвастатина – Сим- вастола. Клин фармакол тер 2005;14(3);33-6.

18. Chalasani N. Chalasani N. Statins and hepatotoxicity: focus on patients with fatty liver. Hepatology. 2005;41:690-5.

19. Chalasani N., Aljadhey H., Kesterson J. Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity. Gastroenterology. 2004;126:1287-92.

20. Clarkson P.M., Hubal M.J. Exercise-induced muscle damage in humans. Am J Phys Med Rehabil 2002;81:S52-S69.

21. Sayers S.P., Clarkson P.M., Rouzier P.A., Kamen G. Adverse events associated with eccentric exercise protocols: six case studies. Med Sci Sports Exerc 1999;31:1697-702.

22. Clarkson P.M., Kearns A.K., Rouzier P., et al. Serum creatine kinase levels and renal function measures in exertional muscle damage. Med Sci Sports Exerc. 2006;38(4):623-7.


For citation:


Tolpygina S.N., Martsevich S.Y. COMPARISON OF EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC DRUGS OF SIMVASTATIN IN PATIENTS WITH HYPERLIPIDAEMIA AND HIGH RISK OF ISCHEMIC HEART DISEASE COMPLICATIONS. Rational Pharmacotherapy in Cardiology. 2008;4(5):23-27. (In Russ.) https://doi.org/10.20996/1819-6446-2008-4-5-23-27

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ISSN 1819-6446 (Print)
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