Vol 17, No 2 (2020)

Cardiovascular diseases (CVD) occupy a leading place in the structure of non-infectious pathology in adults and are the main cause of early disability and premature death in most economically developed countries. According to recent epidemiological studies, there has been a significant increase in both high normal blood pressure (BP) and arterial hypertension (AH) among children and adolescents. This applies to the greatest extent to adolescent children, while AH is detected from 4 to 22% of those surveyed, depending on the age of the surveyed and the selected criteria.

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 2–3 arterial hypertension (AH).

Materials and methods. Russian multicenter prospective clinical study conducted in 8 clinical centers in
6 cities in Russian Federation included 103 patients over 18 years of age with diagnosed essential hypertension of stages 2–3 (in accordance with 2013 European guidelines) who previously did not receive treatment (with office systolic BP – sBP≥160 mm Hg and/or office diastolic BP – dBP≥100 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 59.5±10.9 years (59% female) suffering from AH for 83.4±8.4 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 81.2–95.6%) of the patients. Overall clinical effectiveness (extremely high, very high, high, and sufficient) was achieved in 98.8% [95% confidence interval 93.2–100%] 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 2–3 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 impact of adherence and effectiveness of long-term positive airway pressure therapy (PAP-therapy) on the clinical and psychological characteristics of patients with obstructive sleep apnea syndrome.

Materials and methods. The study included 80 patients who were examined in the sleep apnea laboratory of the Myasnikov Institute of Clinical Cardiology of the National Medical Research Center for Cardiology and who have been on PAP-therapy for more than 12 months. The average age of the patients was 65.0 years [59.0; 71.0], body mass index – 35.0 kg/m² [31.0; 38.0], sleep apnea-hypopnea index (AHI) – 39.5/h [31.0; 62.6]. The average duration of PAP therapy was 3.5 years [2.0; 6.0], while the minimum use was 1 year, the maximum – 15 years. In the sample of patients who came in person, the percentage of days using PAP-therapy was 87.5% [62.0; 98.0] and the average usage time – 6.3 hours [5.2; 7.3].

Results. On long-term PAP-therapy a persistent decrease in AHI was seen on average from 39.5/h [31.0; 62.6] to 2.7/h [1.2; 6.2], p=0,000. The criteria for good adherence to PAP-therapy (use> 4 hours/night, more than 70% of nights) were met by the percentage of days of use – by 67.5% of patients, the average time of use – by 87.5% of patients. Both criteria for good adherence to PAP-therapy was met by 64.8% of patients. With long-term PAP-therapy, 71.7% of patients met the criteria of effectiveness (AHI<5/h), AHI remained >5/h in 22.9% of patients and the average residual AHI was ≥10/h in 5.4% of patients. Correlation analysis showed associations between the PAP-therapy usage parameters and the severity of obstructive sleep apnea syndrome, and sleep quality: percentage of days of use and AHI (r=0.374, p=0.001), average time of use and PSQI (r=-0.438, p=0.000). Patients with a lower adherence to PAP-therapy (63.0% of days [22.0; 96.0] and 3.6 hours [2.4; 4.5] of use) did not differ in daytime sleepiness (ESS 5.0 ­points [2.0; 9.0] and 5.0 points [3.0; 8.0 ], p=0.891), but had a significantly lower quality of sleep (PSQI): 18.0 points [14.0; 20.0] versus 10.0 points [7.0; 18.0], p=0.004 compared with patients with high adherence to PAP-therapy (98.0% of the days [92.0; 99.0] and 7.9 hours [7.5; 8.2] of use).

Conclusions. Patients with the higher adherence to PAP-therapy had significantly better sleep quality. But even the use of PAP-therapy for less than 4 hours is associated with a decrease in daytime sleepiness severity.

Pulmonary hypertension (PH) is a group of diseases with a hemodynamic pattern of progressive increase in pulmonary vascular resistance (PVR) and pulmonary artery pressure (PAP), which leads to right ventricular dysfunction and the development of right ventricular heart failure.

The COVID-19 pandemic that has swept the planet has posed many questions for doctors around the world, including the tactics of managing patients with cardiovascular disease, both infected and self-isolated. A symposium held with the support of the Merck company was devoted to this problem: "COVID-19: a patient with cardiovascular pathology at a particular risk".

VIII Eurasian Congress of Cardiology. Overview of symposiums. New opportunities for reducing cardiovascular risk in the Russian Federation. Systemic Hypertension