THE COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF GENERIC AND ORIGINAL VALSARTAN AS A MONOTHERAPY OR IN COMBINATION WITH HYDROCHLOROTHIAZIDE AND BISOPROLOL IN PATIENTS WITH ARTERIAL HYPERTENSION OF 1-2 DEGREE AND METABOLIC SYNDROME

Aim. To study the efficacy and safety of generic valsartan Valz (Actavis Group, Iceland) in comparison with the original valsartan Diovan® (Novartis, Switzerland) in patients with arterial hypertension (HT) of 1-2 degrees and metabolic syndrome. Material and Methods. 30 hypertensive patients (12 men and 18 women) were enrolled in a randomized open-label crossover study. Each patient received generic and original valsartan (80 mg QD) sequentially during 8 weeks. When target blood pressure (BP) level (<130/80 mm Hg) was not reached, a fixed combination of valsartan with hydrochlorothiazide (80/12.5 mg, and then 160/12.5 mg), and bisoprolol 5 mg/daily , if necessary , were used. Treatment efficacy and safety was assessed at visit to doctor every 2 weeks throughout the study. The sequence of drug use was determined by randomization. Results. Systolic BP (SBP) decreased by 27.5 and 27.4 mm Hg from baseline due to generic and original valsartan 8 week treatment, respectively. Diastolic BP (DBP) decreased by 12.8 and 12.9 mm Hg , respectively (p>0.05). Target BP was achieved in 23 patients (77%) in both randomized groups. Serious adverse reaction were not observed during the treatment with both valsartan drugs. Conclusion. The therapeutic equivalence of generic and original valsartan drugs is shown. Therapy based on valsartan (in combination) was safe and effective in 77% of patients with HT of 1-2 degrees and metabolic syndrome.

1. 1999 World Health Organization - International Society of Hypertension Guidelines for the Management of Hypertension. J Hypertens 1999;17:151-183

2. Reboldi G., Angeli F ., Cavallalini C. et al. Comparison between angiotensin-converting enzyme inhibitors and angiotensin receptor blockers on the risk of myocardial infarction, stroke and death: a meta-analysis. J Hypertens 2008;26(7):1282-9

3. Volpe M., Tocci G., Sciarretta S. et al. Angiotensin II receptor blockers and myocardial infarction: an updated analysis of randomized clinical trials. J Hypertens 2009;27(5):941-6.

4. Coca A., Calvo C., García-Puig J. et al. A multicenter , randomized, double-blind comparison of the efficacy and safety of irbesartan and enalapril in adults with mild to moderate essential hypertension, as assessed by ambulatory blood pressure monitoring: the MAPAVEL study. Clin Ther 2002;24:126-38

5. Pitt B., Poole-Wilson P ., Segal R., Martinez F .A. et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial – the Losartan Heart Failure Survival Study ELITE II. Lancet 2000;355:1582-7

6. McMurray J.J.V., Östergren J., Swedberg K. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet 2003;362:767-71

7. Metelitsa V.I. Guide to Clinical Pharmacology of cardiovascular drugs. Moscow: OOO Meditsinskoe informatsionnoe agentstvo; 2005. Russian (Метелица В. И. Справочник по клинической фармакологии сердечно-сосудистых лекарственных средств. М.: ООО Медицинское информационное агентство; 2005).

8. ESH-ESC Guidelines committee. 2007 guidelines for the management of arterial hypertension. J Hypertens 2007; 25: 1105-87.

9. Reappraisal of European guidelines on hypertension management: a European society of hypertension task force document. J Hypertens 2009; 27: 2121-58.

10. National guidelines for diagnosis and treatment of hypertension. Kardiovaskulyarnaya Terapiya i Profilaktika 2008; 7(6) suppl 2: 1-36. Russian (Национальные рекомендации по диагностике и лечению артериальной гипертонии. Кардиоваскулярная Терапия и Профилактика 2008; 7(6), Приложение 2: 1-36).

11. National guidelines for a rational pharmacotherapy of patients with cardiovascular diseases. Available at: http://scardio.ru/downloads/c4m0i257/recomendacii.doc. Date of access: 02/19/2012 Russian (Национальные рекомендации по рациональной фармакотерапии больных сердечно-сосудистыми заболеваниями. Доступно на: http://scardio.ru/downloads/c4m0i257/recomendacii.doc. Дата доступа: 19.02.2012).

12. Martsevich S.Yu., Kutishenko N.P ., Deev A.D. The original and generic drugs in cardiology. Can you solve the problem of interchangeability. 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).

13. Ruilope L.M., Malacco E., Khder Y . et al. Efficacy and tolerability of combination therapy with valsartan plus hydrochlorothiazide compared with amlodipine monotherapy in hypertensive patients with other cardiovascular risk factors: the VAST study. Clin Ther 2005;27:578–87

14. Julius S., Kjeldsen S.E., Weber M. et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004;363:2022–31.

15. Mancia G. et al. An ambulatory blood pressure monitoring study of the comparative antihypertensive efcacy of two angiotensin II receptor antagonists, irbesartan and valsartan. Blood Press Monit 2002; 7: 135–42.

16. Pfeffer M.A., McMurray J.J., Velazquez E.J. et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003;349:1893–906.