First results of Russian multicenter prospective clinical study VICTORY II: Vamloset® and Co-Vamloset effectiveness and safety in patients with stage 2 and 3 arterial hypertension

Abstract

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.