OPEN-LABEL RANDOMIZED CROSS-SECTIONAL STUDY OF CLINICAL EQUIVALENCE OF GENERIC AND ORIGINAL VALSARTAN IN PATIENTS WITH ARTERIAL HYPERTENSION

To compare antihypertensive effectiveness and changes of lipid and carbohydrate metabolism profiles, erectile function and life quality in patients with arterial hypertension (AH) while being treated by generic valsartan (Tantordio) comparing to the original. Material and methods. Totally we included 60 patients with AH, mean age 54,6±3,1. Patients were randomized into 2 groups: I (n=30) were assigned for generic valsartan (Tantordio) and II (n=30) were taking original drug. In 4 weeks patients from the group I were switched to the original drug, and patients from II group — to generic. At baseline, in 4 and 8 weeks of drug intake patients underwent blood pressure (BP) assessment and heart rate (HR) measurement, laboratory tests for lipid profile and fasting plasma glucose, life quality questionnaires and erectile function assessment in men. Results. Tolerability of the drugs studied in both groups was good enough. Antihypertensive effect of generic valsartan (Tantordio) and the original was comparable. We noted a decrease of systolic BP (SBP) in patients from the Igroup by 25% and of diastolic BP (DBP) by 20%, and in patients from II group SBP decrease by 25% and DBP — by 20%. Dynamics of BP in men and women did not differ significantly. In both groups we found significant HR decrease. Also in both groups we found significant HR decrease. There were comparable to the original valsartan positive metabolic effects of generic valsartan. While taking generic valsartan there was comparable to the original drug decrease of levels of total cholesterol, LDL cholesterol and triglycerides. An increase of HDL cholesterol was found only in the II group from 1,6±0,5 mmol/L to 1,7±0,5 mmol/L. In both groups we found comparable and significant decrease of fasting plasma glucose inside normal ranges. In women this value did not change, but in men there was a decrease from 5,7±0,5 mmol/L to 5,4±0,4 mmol/L. In all groups we found significant increase of erectile function parameters in men, comparable in both groups increase of life quality parameters without relevant differences by gender. Conclusion. The results of the study have confirmed antihypertensive effectiveness and metabolic benefits of valsartan. Generic valsartan (Tantordio) showed clinical equivalence to the original drug.

arterial hypertension, sexual function, life quality, valsartan

1. Lithell H, Hansson L, Skoog I, et al. The Study on Cognition and Prognosis in the Elderly (SCOPE): principal results of a randomized double-blind intervention trial. J Hypertens 2003; 21: 875-86.

2. Calvo C, Hermida RC, Ayala DE, et al. Effects of telmisartan 80 mg and valsartan 160 mg on ambulatory blood pressure in patients with essential hypertension. J Hypertens 2004; 22(4): 837-46.

3. Fogari R, Mugellini A, Zoppi A, et al. Efficacy of losartan, valsartan, and telmisartan in patients with mild to moderate hypertension: A double-blind, placebo-controlled, crossover study using ambulatory blood pressure monitoring. Curr Ther Res 2002; 63: 1-14.

4. Podzolkov VI, Bulatov VA, Vigdorchik AV. Valsartan in routine clinical practice in Russia: The antihypertensive effect and impact on sexual function in patients with hypertension. Rational Pharmacother Cardiol 2010; 6(2): 166-72. Russian (Подзолков В.И., Булатов В.А., Вигдорчик А.В. Валсартан в повседневной клинической практике России: Антигипертензивный эффект и влияние на сексуальную функцию у пациентов с артериальной гипертонией. Рациональная Фармакотерапия в Кардиологии 2010; 6(2): 166-72).

5. Pfeffer MA, McMurray JJ, Velazquez EJ, 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.

6. Viberti G, Wheeldon NM. Microalbuminuria reduction with valsartan in patients with type 2 diabetes mellitus: a blood pressure-independent effect. Circulation 2002; 106: 672-8.

7. Healey JS, Baranchuk A, Crystal E, et al. Prevention of atrial fibrillation with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: a metaanalysis. JACC 2005; 45(11): 1832-9.

8. Elliott WJ, Meyer PM. Incident diabetes in clinical trials of antihypertensive drugs: a network meta-analysis. Lancet 2007; 369: 201-07.

9. Weycker D, Falvey H, Edelsberg J, et al. Risk of diabetes in hypertensive patients receiving valsartan versus losartan. J Clin Hypertens 2007; Suppl A (9): P448.

10. Della Chiesa A, Pfiffner D, Meier B, et al. Sexual activity in hypertensive men. J Hum Hypertens 2003; 17(8): 515-21.

11. Fogari R, Preti P, Derosa G, et al. Effect of antihypertensive treatment with valsartan or atenolol on sexual activity and plasma testosterone in hypertensive men. Eur J Clin Pharmacol 2002; 58(3): 177-80.

12. Dusing R. Effect of the angiotensin II antagonist valsartan on sexual function in hypertensive men. Blood Press Suppl 2003; 2: 29-34.

13. Fogari R, Zoppi A, Poletti L, et al. Sexual activity in hypertensive men treated with valsartan or carvedilol: a crossover study. Am J Hypertens 2001; 14(1): 27-31.