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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

Keywords: valsartan , arterial hypertension , metabolic syndrome , combined antihypertensive therapy , fixed combinations.

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Abstract:

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.

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