The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension

Abstract

Objective. The VICTORY study aimed to evaluate effectiveness and safety of monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in clinical practice in patients with stage 1 and stage 2 hypertension. Materials and methods. In the prospective, randomized, open-label, international multicentre study involved 356 patients with grade 1 and grade 2 hypertension from 5 countries, including 130 patients from Russia. In Russia the study was conducted in 7 cities, in 8 clinical centers. The patients, who were receiving antihypertensive therapy at the moment of screening, underwent a 7 days wash-out period. The starter dose of valsartan (Valsacor®, KRKA, Slovenia) was 80 mg (except for Russia where 160 mg of Valsacor® were given at the first visit, what did not influence the study results). After 4 weeks of treatment in case of blood pressure (BP) >140/90 or 130/80 mm Hg the dose was increased to 160 mg (in Russia - to 320 mg) or combined therapy with Valsacor® H (KRKA, Slovenia) was prescribed. In 4 weeks the dose of valsartan was increased to 320 or 160/12.5 mg in case of previous dose insufficiency. If target BP levels were not reached in the next 4 weeks, the dose was increased to 320/12.5 mg. The primary endpoints included evaluation of antihypertensive effect of valsartan and its fixed combination with hydrochlorothiazide on BP levels; evaluation of the drugs’ influence on aortal stiffness; comparison of absolute average means of achieved decrease in central and peripheral BP compared with baseline; evaluation of the impact on aortic augmentation index. The secondary endpoints included comparison of primary endpoints when using mono and combined therapy; evaluation and comparison of the effect on erectile function in men by questionnaires at baseline and after 16 weeks of treatment; evaluation of adverse events frequency. Results. Data on 365 patients - 196 (54.0%) female and 169 (46.0%) male aged 54.6±12.0 years were analyzed. Mean initial value of systolic (SBP) and diastolic BP (DBP) were 156.6±8.9 and 95.6±6.0 mm Hg, respectively and 130.1±8.2 and 80.9±5.8 mm Hg, respectively after 16 weeks of treatment. The mean absolute decrease of SBP and DBP was 26.6±10.4 and 14.8±7.6 mm Hg. The decrease of SBP and DBP was statistically significant in all treatment periods (p