Abstract VICTORY II study objective. Evaluation of Vamloset and Co-Vamloset safety and effectiveness in reaching target blood pressure (BP) level in patients with stages 23 arterial hypertension (AH). Materials and methods. Russian multicenter prospective clinical study conducted in 8 clinical centers in6 cities in Russian Federation included 103 patients over 18 years of age with diagnosed essential hypertension of stages 23 (in accordance with 2013 European guidelines) who previously did not receive treatment (with office systolic BP sBP160 mm Hg and/or office diastolic BP dBP100 mmHg) or did not achieve target BP levels after receiving mono- or dual therapy. Office BP target levels comprised 139 mmHg for sBP and 89 mm Hg for dBP for patients without diabetes mellitus (DM), and 139 mm Hg for sBP and 84 mm Hg for dBP for patients with DM. All patients with stage 2 AH (group 1) were prescribed Vamloset (amlodipine/valsartan, 5/80 mg), patients with stage 3 AH Vamloset (amlodipine/valsartan, 5/160 mg). Therapy correction Vamloset (amlodipine/valsartan) in doses 5/160 mg, 10/160 mg and Co-Vamloset (amlodipine/valsartan/hydrochlorothiazide) in doses 10/160/12,5 mg, 10/160/25 mg (КРКА-RUS) was performed every 4 weeks according to provided schemes. At follow-up every 4 weeks the decision on necessity of antihypertensive treatment (AHT) correction were made by medical researcher in accordance with analysis of patients complaints, general condition and physical examination, results of office BP measurement, diary of BP self-control. In 40 patients in subgroup with additional assessment 24-hour BP monitoring, pulse wave velocity measurement, central BP evaluation, augmentation index calculation, and endothelium damage markers determination were performed. Results. Active phase of the study included 100 patients aged 59.510.9 years (59% female) suffering from AH for 83.48.4 months. The patients received treatment with study medication (safety population). The protocol population (sampling Per Protocol) included 80 patients who completed the study without severe protocol violation. At the moment of study entrance 83% of patients received AHT. In all patients treatment duration comprised 15.9 weeks. In Per Protocol population target office BP level was achieved by 90.0% (95% confidence interval 81.295.6%) of the patients. Overall clinical effectiveness (extremely high, very high, high, and sufficient) was achieved in 98.8% [95% confidence interval 93.2100%] of the patients. In group of patients with stage 2 AH target office BP level was achieved by 93.8% of patients, in group with stage 3 AH by 84.4% of patients. Mean BP change in study group was -32.2 mm Hg for SBP and -16.0 mm Hg for DBP. Among patients with stage 2 AH target office BP level was achieved by 93.8% of patients, with mean BP change -30,7 mm Hg for SBP and -15.5 mm Hg for DBP. In patients with stage 3 AH target BP levels were achieved in 84.4% of patients with mean BP change -34,6 mm Hg for SBP and -16.7 mm Hg for DBP. After 16 weeks of treatment in Full Analysis Set population with recovery of missed measures using Last Observation Carried Forward 40.2% of patients reached target BP levels according to BP self-control results. Considering the limitations of results evaluation this practice requires further assessment, standardization, and improvement. According to 24-hour BP monitoring reaults after 16 weeks of treatment 26.5% of patients achieved target BP daily profile (for patients from subgroup with additional assessment in Full Analysis Set population with recovery of missed measures using Last Observation Carried Forward), that indicates additional influence of studied AHT on the prognosis of patients with stages 23 AH. Conclusion. In clinical study VICTORY II Vamloset and Co-Vamloset optimal effectiveness and safety in patients with stage 2 and 3 arterial hypertension were shown.
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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