Preview

Rational Pharmacotherapy in Cardiology

Advanced search

ESTIMATION OF CLINICAL AND PHARMACOKINETIC EQUIVALENCE OF ORIGINAL AND GENERIC CARVEDILOLS IN PATIENTS WITH HYPERTENSION OF 1-2 GRADES

https://doi.org/10.20996/1819-6446-2008-4-3-39-44

Full Text:

Abstract

Aim. To study clinical equivalence of original (DilatrendR, ≪Hoffmann-La Roche≫, Switzerland) and of generic (VedicardolR, ≪Synthesis≫, Russia) carvedilols with estimation of their serum level. And to study pharmacoeconomic advantages of their usage in patients with arterial hypertension (HT) of 1-2 stages.

Material and methods. Study was double blind, randomized, crossed. 30 patients (8 men and 22 women, 57 y.o. average) with HT of 1 stage (3,3 %) and 2 stage (96,7 %) were included in the study. Original or generic carvedilols (12,5 mg twice a day) were prescribed to the patients. Hydrochlorothiazide was added followed carvedilol dose enlargement if initial antihypertensive effect had been insufficient. The second similar course of therapy with other carvedilol took place in 2 weeks after cancellation of the first carvedilol. Carvedilol serum level, blood pressure (BP), heart rate (HR) and side effects were registered on each visit.

Results. 75 % of Vedikardol-group patients and 75 % of Dilatrend-group patients had reached target BP level (<140/90 mm Hg). Monotherapy was effective more than in a half of patients in both groups. Dilatrend had more expressed influence on HR in comparison with Vedikardol. Both drugs did not differ significantly in frequency and intensity of side effects.

Conclusion. Generic carvedilol (VedicardolR) has clinical efficiency and pharmacokinetics similar to these of original carvedilol (DilatrendR). Generic carvedilol has lower cost of treatment than this in original carvedilol.

About the Authors

E. I. Bambysheva
State Research Center of Preventive Medicine of Rosmedtechnology, Moscow
Russian Federation


S. N. Tolpygina
State Research Center of Preventive Medicine of Rosmedtechnology, Moscow
Russian Federation


D. F. Guranda
State Research Center of Preventive Medicine of Rosmedtechnology, Moscow
Russian Federation


I. E. Koltunov
State Research Center of Preventive Medicine of Rosmedtechnology, Moscow
Russian Federation


V. G. Belolipetskaja
State Research Center of Preventive Medicine of Rosmedtechnology, Moscow
Russian Federation


S. J. Martsevich
State Research Center of Preventive Medicine of Rosmedtechnology, Moscow
Russian Federation


References

1. Mancia G., De Backer G., Dominiczak A., et al. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007;25(6):1105-87.

2. Метелица В.И. Справочник по клинической фармакологии сердечно-сосудистых лекарственных средств. М.:Медицинское информационное агентство; 2005.

3. Lpez-Sendn J., Swedberg K., McMurray J. et al.; The Task Force on Beta-Blockers of the European Society of Cardiology. Expert consensus document on betaadrenergic receptor blockers. Eur Heart J 2004;25:1341-62.

4. Sponer G., Bartsch W., Strein K., Muller-Beckmann B., Bohm E. Pharmacological profile of carvedilol as a beta-blocking agent with vasodilating and hypotensive properties. J Cardiovasc Pharmacol 1987;9(3):317-327.

5. Weber K., Bohmeke T., van der Does R., Taylor S.H. Comparison of the hemodynamic effects of metoprolol and carvedilol in hypertensive patients. Cardiovasc Drugs Ther 1996;10(2):113-7.

6. Giugliano D., Acampora R., Marfella R., et al. Metabolic and cardiovascular effects of carvedilol and atenolol in non-insulin-dependent diabetes mellitus and hypertension. A randomized, controlled trial. Ann Intern Med 1997;126(12):955-9.

7. Pollare T., Lithell H., Selinus I., Berne C. Sensitivity to insulin during treatment with atenolol and metoprolol: a randomized, double blind study of effects on carbohydrate and lipoprotein metabolism in hypertensive patients. BMJ 1989;298(6681):1152-7.

8. Lysko P.G., Webb C.L., Gu J.L. et al. A comparison of carvedilol and metoprolol antioxidant activities in vitro. J Cardiovasc Pharmacol 2000;36(2):277-81.

9. Noguchi N., Nishino K., Niki E. Antioxidant action of the antihypertensive drug, carvedilol, against lipid peroxidation. Biochem Pharmacol 2000;59(9):1069-76.

10. Weber M.A., Sica D.A., Tarka E.A. et al. Controlled-release carvedilol in the treatment of essential hypertension. Am J Cardiol 2006;98(7A):32L-38L.

11. Недогода С.В., Марченко И.В., Чаляби Т.А. Сравнительная гипотензивная эффективность дженериков ингибитора ангиотензинпревращающего фермента эналаприла – ренитека (энапа, эднита, инворила, энваса и энама) и стоимость лечения у больных гипертонической болезнью. Артериальная гипертензия 2000;6(1):52-4.

12. Красных Л.М., Савченко А.Ю., Раменская Г.В., Кукес В.Г. Определение относительной биодоступности и биоэквивалентности препаратов карведилола – Ведикардола и Дилатренда. Трудный пациент 2006;(10):15-7.

13. Morgan T. Clinical pharmacokinetics and pharmacodynamics of carvedilol. Clin Pharmacokinet 1994;26:335-46.

14. Leonetti G., Sampieri L., Cuspidi C. et al. Resting and postexercise hemodynamics effects of carvedilol, a,b-adrenergic blocker and precapillary vasodilator in hypertensive patients. J Cardiovasc Pharmacol 1987;10 Suppl 11:S94-6.


For citation:


Bambysheva E.I., Tolpygina S.N., Guranda D.F., Koltunov I.E., Belolipetskaja V.G., Martsevich S.J. ESTIMATION OF CLINICAL AND PHARMACOKINETIC EQUIVALENCE OF ORIGINAL AND GENERIC CARVEDILOLS IN PATIENTS WITH HYPERTENSION OF 1-2 GRADES. Rational Pharmacotherapy in Cardiology. 2008;4(3):39-44. (In Russ.) https://doi.org/10.20996/1819-6446-2008-4-3-39-44

Views: 355


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


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