Aim. To study the effect of gender, age, duration of disease and different forms of ischemic heart disease on the stiffness of the vascular wall in patients with arterial hypertension by determining the propagation velocity of the pulse wave. Materials and methods. In order to study the propagation velocity of the pulse wave it was examined 369 patients with the method of volumetric sphygmography. In all patients was diagnosed arterial hypertension I-III stage, 1-3 degree, besides 47 patients were diagnosed with stable angina I-III functional class, 50 patients had a history of prior myocardial infarction. The investigation was held with the help of hardware complex "Poli-Spektr" made by Neirosoft firm (city Ivanovo) by the classical method of determining the propagation velocity of the pulse wave using synchronous registration sphygmograms of the carotid, radial and femoral arteries. Results. Patients with arterial hypertension had statistically higher velocity of pulse wave propagation for elastic-type vessels in comparison with healthy volunteers (9.48±0.18 и 7.28±0.64 cm/sec; р
Objective - to explore influence of valsartan monotherapy use and its use in combination with hydrochlorothiazide (HCTZ) on pulse-wave velocity (PWV) and central arterial pressure (CAP) in patients with arterial hypertension (AH) of 1-2 grades in international VICTORY clinical trial. Materials and methods. The international multicenter prospective randomized clinical study VICTORY that lasted for 16 weeks included patients with 1-2 grades AH. In patients who previously received antihypertensive therapy a 7 days washout period was carried out. All patients started their therapy with 80 mg valsartan (Valsacor®, KRKA, Slovenia); in Russia the starter dose of Valsacor®, KRKA was 160 mg in previously treated patients that did not influence the study results. If after 4 weeks of treatment BP was more than 140/90 mm hg (more than 130/80 mm hg in high risk patients or in diabetes mellitus patients) the dose of valsartan was increased to 160 mg (320 mg in Russia) or diuretic in fixed combination with valsartan was added (160 mg valsartan/12.5 mg HCTZ): Valsacor® H 160 (KRKA, Slovenia). If target BP after 8 weeks of treatment was not reached valsartan dose was increased to 320 mg or fixed combination of valsartan and diuretic (160 mg/12.5 mg) was used. If target BP after 12 weeks of treatment was not reached - valsartan and diuretic 320 mg/12.5 mg were used. PWV and CAP (SphygmoCor®, AtCorMedical) were assessed at baseline and after 16 weeks of treatment. The primary endpoints were assessment of the impact of studied medications on aortic stiffness, aortic augmentation index and comparison of absolute medians of reached central and peripheral BP reduction with baseline value. Results. Of 365 patients included in the study 74 were included in PWV and CAP study subgroup. Valsartan and its combination with HCTZ were effective in CBP reduction. The mean absolute reduction of central systolic and diastolic BP after 16 weeks of treatment was 19.7±12.9 mm hg and 13.9±8.5 mm hg, respectively (р
Aim. To assess the efficacy and safety of Vamloset (amlodipine/valsartan 5/80, 5/160, 10/160 mg) and Co-Vamloset (amlodipine/valsartan/hydrochlorothiazide 10/160/12.5, 10/160/25 mg) in achieving the target levels of blood pressure (BP) in patients with stage 23 arterial hypertension (AH). The article discusses indicators affecting adherence to antihypertensive therapy (AHT). Material and methods. The VICTORY II Russian study in 8 clinical centers of the Russian Federation included 103 patients over 18 years of age with stage 23 essential AH (who havent been previously treated and have office systolic BP160 mm Hg and/or diastolic BP100 mm Hg or who havent reached the target office blood pressure with mono- or double AHT). The Full Analysis Set (FAS) for efficacy analysis included 99 patients, a FAS population with the restoration of data missed using Last Observation Carried Forward. The SF-36 questionnaire for assessing the quality of life, the effect on erectile function in men, the convenience of current therapy from the point of view of patients were analyzed after 16 weeks of treatment. The Per Protocol (PP) population included 80 patients completing the study without major protocol deviations to assess the primary parameters of efficacy. All patients with stage 2 hypertension were prescribed Vamloset (amlodipine/valsartan 5/80 mg), with stage 3 hypertension amlodipine/valsartan 5/160 mg. Dose titration of Vamloset and Co-Vamloset (LLC Krka-RUS) was carried out every 4 weeks according to the AHT schemes. Results. The studys active phase included 100 patients aged 59.510.9 years (women 59%) with AH duration of 83.48.4 months; 83% of patients received AHT prior inclusion in the study. In the PP population, 16 week- AHT with Vamloset or Co-Vamloset allowed reaching the target BP in 90.0% of patients (95% confidence interval [CI] 81.295.6). Overall clinical efficacy was achieved in 98.8% of patients (95% CI 93.2100.0). All treatment regimens were characterized by high patient compliance. In the total group, 50% of patients rated their AHT as more convenient than they had previously used; of them, in the stage 2 AH group 47.8%, in the stage 3 AH group 53.3%. Metabolic neutrality with regard to at least one indicator was observed in 100% of patients, with regard to 6 indicators in 43.9% [33.9; 54.9]. For all 98 patients included in the analysis, changes in all SF-36 scales, except for physical functioning (p=0.339), were statistically significant (p0.05). The effect of AHT on erectile function was rated as positive in 51.3% of men. Good tolerance data are consistent with the established drug safety profile. Conclusion. In the VICTORY II study, high antihypertensive efficacy and an improvement in a set of indicators of optimal adherence to AHT by Vamloset and Co-Vamloset within 16 weeks were proved in patients with stage 23 AH. Patients high rating for quality improvement in the quality of life, safety of therapy and ease of use ensured optimal compliance of Vamloset and Co-Vamloset therapy throughout the study.
Aim.Assessment of Vamloset and Co-Vamloset effects on blood pressure target levels and indicators associated with organ protection: albuminuria; elasticity of arteries and central aortic pressure (CAP); endothelial function; tumor necrosis factor-a, interleukin (IL) IL-6 and IL-10, vascular cell adhesion molecule 1 and vascular endothelial growth factor (VEGF-A). Materials and methods.The Russian multicenter open-label prospective clinical study VICTORY II which was conducted in 8 clinical centers included 103 patients 18 years with grade 23 essential arterial hypertension (AH), who were previously untreated office systolic blood pressure (SBP) 160mmHg and/or office diastolic blood pressure (DBP) 100 mm Hg or have not reached the target office blood pressure with mono- or dual therapy. The active phase of the study included 100 patients; the per-protocol (PP) population 80 patients completing the study without major protocol deviations. Patients were not randomized. The target office BP for patients without diabetes were: SBP139 mm Hg, DBP89 mm Hg; for patients with diabetes: SBP139 mm Hg, DBP84 mm Hg. All patients with grade 2 hypertension (group 1) were administrated Vamloset (amlodipine/valsartan, 5/80mg), with grade 3 hypertension Vamloset (amlodipin/valsartan, 5/160 mg). Up-titration of the dose of amlodipine/valsartan to 5/160 mg and 10/160 mg, the administration of Co-Vamloset (amlodipine/valsartan/hydrochlorothiazide) in doses of 10/160/12.5 mg, 10/160/25 mg (LLC KRKA-RUS) was carried out every 4 weeks according to the prescribed schemes. In the total group, the effect of studied therapy on the level of albumin in the urine was assessed. Before starting treatment and after 16 weeks of treatment, 40 patients in the subgroup with additional examinations underwent daily monitoring of blood pressure, assessment of pulse wave velocity and augmentation index; CAP; levels of tumor necrosis factor-, IL-6 and IL-10, vascular cell adhesion molecule 1and VEGF-A. Results.The active phase of the study included 100 patients aged 59.510.9 years (59% of women) with a duration of AH 83.48.4 months. 83% of patients received prior antihypertensive therapy by the time of enrollment in the study. The treatment duration for all patients was 15.9 weeks. After 16 weeks, therapy with Vamloset and Co-Vamloset provided an optimal decrease in BP: 90% of patients with grade 23 AH in the PP population reached the target level of office BP, the mean change in SBP / DBP was -32.2/-16.0 mm Hg. According to the data of daily monitoring of BP in the subgroup with additional examinations, the target levels of average daily SBP/DBP were reached in 52.9/67.6% of patients, respectively. Along with reliable control of blood pressure, additional organ protection with studied antihypertensive drugs after 16 weeks of therapy was shown by assessment data: albuminuria in 58.8% of patients with an initially elevated level of albuminuria (n=17), a positive effect of the studied therapy on the level of albumin in the urine was determined, augmentation index improvement in 57.1% of patients in the study group, CAP improvement in 73% of patients in the study group; positive dynamics of endothelial damage markers (IL-6, IL-10, VEGF-A) was achieved. The data on the good tolerability of AHT corresponded to the previously established safety profile of these drugs. Conclusion.In the VICTORY II clinical study in patients with grade 23 hypertension, along with high antihypertensive efficacy, a spectrum of organoprotective effects of Vamloset and Co-Vamloset on aortic stiffness with improved augmentation index and CAP, markers of endothelial damage (IL-6, IL-10, VEGF-A), the severity of albuminuria was shown.
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