Achieve Target Blood Pressure Levels Research Articles

Fixed dose combination of olmesartan and amlodipine in patients with hypertension and abdominal obesity. Data of 3-month observation of efficacy and adherence to therapy

Abstract Funding Acknowledgements Type of funding sources: None. Background Essential hypertension (H), which is combined with abdominal obesity (AO), is characterized by the early formation of refractoriness to antihypertensive therapy. In this regard, it is urgent to search for the most effective therapy regimens, among which fixed combinations (FC) of drugs have recently attracted considerable interest. Purpose To study the efficacy of FC olmesartan (O) and amlodipine (F) and adherence to it in patients with H and AO. Methods. 60 patients with grade 2 H with AO of I-II degrees (36 men and 24 women aged 48 to 62 years) were examined using standard clinical, biochemical and instrumental methods. Before enrollment in the study, all patients received various non-FC two-component combinations of antihypertensive drugs, however, target blood pressure (BP) levels were not achieved by any patient. After inclusion in the study, all patients were transferred to FC O and A, which was prescribed once a day , taking into account BP levels in the following daily doses: 20/5 mg; 40/5 mg and 40/10 mg. The examination was carried out for 3 months with dose adjustments every 7-10 days. Results. The use of FC O and A made it possible to achieve the target BP level after 3 month of therapy in 72% of patients with H and AO. At the same time, high adherence to this therapy was also noted: 80% of patients continued to receive this therapy for 3 months. It was found that in order to achieve target BP levels, in 84% of patients it was necessary to use O and A in a daily dose of 40/10 mg, in 16% of patients -in a dose of 40/5 mg. The tested FC was characterized by a low incidence of side effects, the most frequent of which was leg edema (in 7% of patients) and good tolerability (therapy withdrawal rate was 3%). Conclusion. The established high antihypertensive efficacy and tolerability of FC O and A in patients with H and AO indicates the promise of its widespread use in this category of patients.

Hemodynamic and metabolic disorders in obese patients with resistant hypertension

Abstract Resistant hypertension (RH) is an important cause of cardiovascular morbidity and mortality. Both true and pseudo-resistant arterial hypertension (AH) represent a big problem not only in blood pressure (BP) control, but also in those possible adverse cardiovascular events, the development of which is associated with failure to achieve target BP levels. The aim of the study was to establish the features of hemodynamic and metabolic parameters in obese patients with true and pseudo-resistant AH. Material and methods The study included 200 patients with uncontrolled AH and obesity. Patients were initially prescribed dual antihypertensive therapy. Those patients who did not reach target BP levels after 3 months on dual therapy were additionally assigned a third antihypertensive drug. Of the 98 patients who were assigned triple therapy, 48 patients did not reach target BP (27 patients had pseudo-resistant and 21 patients had true resistant AH). These patients were additionally prescribed a fourth antihypertensive drug (spironolactone). The effectiveness of the treatment was evaluated 6 months after the start of antihypertensive therapy. Results After 6 months of therapy, patients with RH had higher body mass index (BMI) and higher BP levels compared to patients without this condition. Patients with RH also had more pronounced cardiovascular remodeling, higher levels of triglycerides, insulin, HbA1c, more pronounced insulin resistant (IR), which was confirmed by greater HOMA-IR, greater imbalance of adipokines, proinflamation activity and higher activity of the renin-angiotensin-aldosterone system (RAAS). A comparative assessment of pseudo-resistance and true resistance showed that patients with true resistance differed from pseudo-resistant patients with significantly lower BMI (p=0.02). In addition, in the absence of differences in BP levels, cardiovascular remodeling, lipid and carbohydrate profiles, patients with true resistance had significantly higher levels of aldosterone (p=0.04), higher activity of oxidative stress (malonic dialdehyde, p=0.01 and diene conjugates, p=0.03), a lower level of total antioxidant protection (p=0.00), a higher level of adiponectin (p=0.00), and a lower level of leptin (p=0.00), compared with pseudo-resistant patients. Conclusions Patients with resistant hypertension differed from hypertensive obese patients without resistance with higher BMI and BP, higher levels of triglycerides, insulin, HbA1c, more pronounced IR, cardiovascular remodeling, imbalance of oxidative stress - antioxidant protection system, higher proinflammatory and RAAS activity. Patients with true resistance differed from pseudo-resistant patients with significantly lower BMI, higher aldosterone levels, more pronounced imbalance of the system of oxidative stress - antioxidant protection and less pronounced adipokines imbalance. Funding Acknowledgement Type of funding source: None

The Influence of Metabolic Therapy on Daily Blood Pressure Monitoring Dynamics in Hypertensive Patients

The objective: is to assess the efficiency of metabolic therapy on blood pressure indicators based on the results of daily blood pressure monitoring in hypertensive patients.Materials and methods. The results of daily blood pressure monitoring in patients with stage II hypertension of 2–3 degrees are presented. 50 patients (including 28 men and 22 women) were examined. The mean age of patients was 44.6±10.9 years. Hypertensive patients received basic combination antihypertensive therapy with individually selected doses of ramipril / amlodipine in combination with metabolic therapy with0.5 g of quercetin. Сorvitin dissolved in 50 ml of isotonic sodium chloride solution intravenously / 2 times a day after 12 hours during 5 days; during next 30 days of outpatient treatment patients received 40 mg of quercetin orally 3 times a day. All patients underwent daily blood pressure monitoring using HEACO ABPM 50 device.Results. The use of combined antihypertensive and metabolic therapy contributes to the normalization of blood pressure during the day, allows achieving target blood pressure levels in most patients which is manifested by the improvement of the daily blood pressure profile based on the results of the daily blood pressure monitoring.Conclusion. The use of quercetin (corvitin, quartin) in complex therapy with the use of combination antihypertensive drug ramipril / amlodipine reveals an additional antihypertensive effect which can be successfully used in the treatment of hypertensive patients.

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
 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.

Prospects for Blood Pressure Remote Monitoring in Hypertensive Patients in the Ryazan Region

Aim. To study the effectiveness and benefits of blood pressure (BP) remote monitoring in outpatients with hypertension.Material and methods. The study included 100 patients with a verified diagnosis of hypertension, who didn’t achieve target BP pressure levels. The patients measured their BP twice a day over 6 months with facilities with automatic data transmission over GSM-channel to a remote monitoring center. BP parameters were being transmitted online to the remote monitoring center, where they were being processed and transferred to the personal account planner (created by the Web interface based on the software and hardware complex) of the attending physician and operator of the remote monitoring center. It is important that doctor received information only on clinically significant measurement results, based on which he determined the urgency of contact with the patient and the further tactics of his management.Results. No malfunctions in the work of communication facilities, technical failures in the software and hardware complex were registered over the entire period of the study. After 6 months of the monitoring it was possible to achieve target BP levels less than 135/85 mm Hg in 70% of patients. The proportion of patients with a high level of normal BP increased from 10% to 19%, while the proportion of patients with grade 1 and 2 of hypertension decreased significantly (from 33% to 7% and from 54% to 3%, respectively). At the beginning of telemedicine monitoring 3% of patients had stage 3 of hypertension, at the end of the study – 1%.Conclusion. The technology of telemedicine monitoring has shown itself as a simple, affordable and reliable way of management of outpatients with hypertension in conditions of real clinical practice. It was possible to achieve BP levels less than 135/85 mm Hg in 70% of patients by the method of remote outpatient monitoring. BP remote monitoring changed fundamentally the decision-making strategy of the patients management: it was not the patient who independently determined the need for consultation with a medical professional, but the attending physician made a decision on the method and urgency of contact with the patient on the basis of the data of objective monitoring indicators.

P6364Challenges of implementation of new European Guidelines 2018 on hypertension in a real clinical practice

Abstract Objective Novel European guidelines 2018 on Hypertension raised the question about the implementation of new target blood pressure (BP) levels into real practice. The aim of the present study was to compare achieved target BP levels in clinical practice according to European guidelines 2013 and 2018. Design and methods Data of 25428 hypertensive patients form the electronic data base of ambulatory of the Research Centre during 2016–2018 years were analyzed. 8484 hypertensive patients were examined in 2016, 8490 patients – in 2017 and 8454 patients – in 2018 year. Only patients with hypertension as the major disease and on current medication were and under the age of 80 years included. Results Applying the Guidelines 2013, 5978 patients (23,5%) were on target and have had BP control under 140/90 mm Hg, while according to new Guidelines 2018 only 1749 patients (6,9%) have achieved recommended BP level under 130/80 mm Hg. BP control according to both Guidelines Year Sex Age group Number of hypertensive patients BP <140/90 mm Hg BP <130/80 mm Hg 2016 Women Under 50 716 208 (29%) 72 (10,1%) Women 50 and older 4894 1197 (24,5%) 344 (7,0%) Men Under 50 997 252 (25,3%) 57 (5,7%) Men 50 and older 1877 402 (21,4%) 104 (5,5%) 2017 Women Under 50 716 201 (28,1%) 66 (9,2%) Women 50 and older 4734 1049 (22,2%) 325 (6,9%) Men Under 50 1156 266 (23%) 59 (5,1%) Men 50 and older 1884 339 (18%) 84 (4,5%) 2018 Women Under 50 744 224 (30,1%) 87 (11,7%) Women 50 and older 4544 1126 (24,8%) 360 (7,9%) Men Under 50 1364 312 (22,8%) 80 (5,9%) Men 50 and older 1802 402 (22,3%) 111 (6,2%) Conclusion According to the previous criteria approximately quarter of all hypertensive patients in real clinical practice in St.Petersburg are on target, while recommended in 2018 Guidelines new target levels are achieved less that in 12%t. Women under 50 have a better BP control. It seems that implementation of new targets for BP will be extremely hard and needs huge investment in education, motivation, compliance and new strategies.

Efficacy and tolerability of a fixed combination of bisoprolol and perindopril in the treatment of hypertensive patients after revascularization for acute coronary syndrome

Objective. To study the efficacy and tolerability of a fixed combination of bisoprolol and perindopril in the treatment of hypertensive patients after revascularization for acute coronary syndrome (ACS) at the third (outpatient) stage of cardiological rehabilitation. Design and methods . In total, 1004 patients who underwent coronary artery stenting due to ACS were followed-up by cardiologists after discharge from the vascular departments of hospitals in Omsk. Their data were analyzed after 6 months (lipids, blood pressure (BP), total mortality, hospitalization rate). Among them, 91 patients were not included in the physical cardiological rehabilitation program due to the non-target values of BP and heart rate (HR). All of them took free combinations of beta-blockers and angiotensin-converting enzyme (ACE) inhibitors. They were offered to change a free combination to a fixed one including bisoprolol and perindopril in individual doses (5/5, or 5/10, or 10/10 mg). We estimated the office BP, HR at three time points: at the start of therapy (1st visit, V1), after 4 weeks (V2) and after 12 weeks (V3). The BP variability and patients’ adherence to treatment were also assessed. Results. After 4 weeks of treatment by the fixed combination of bisoprolol and perindopril, BP and HR decreased: 92,0 % achieved target BP levels, while target HR was achieved in 95,4 %. At V3, after dose titration, target BP and heart rate were achieved in all patients. After 12 weeks of treatment, the variability of systolic BP (SBP) and diastolic BP (DBP) was normalized in 80,4 % and 88,1 %, respectively (p < 0,001). Individual target HR in patients with heart failure symptoms and/or angina pectoris was not achieved in 91,3 % respondents at V1, in 18,5 % at V2, in 4,6 % at V3. At V2, 50 people (54,9 %) were considered eligible for the individual physical rehabilitation. At V3, additional 38 (41,7 %) patients were re-evaluated as eligible for the physical rehabilitation program. Patients demonstrated improved adherence to treatment: from V1 to V2 the compliance increased up to 73,0 % (p < 0,01), at V3 — up to 78,0 % (p < 0,001). We assessed the intention to continue the treatment, the answers were the following: “I don’t know” — 2,4 %, “perhaps” — 40,7 %, “definitely” — 56,7 %. Conclusions. Our study demonstrate the need for a wider implementation of the fixed combination of bisoprolol and perindopril in management of hypertensive patients after ACS.

Antihypertensive and Target-Organ Protective Properties of Telmisartan and Hydrochlorothiazide Single-Pill Combination

The most important result of the revision of the European and Russian guidelines for the management of arterial hypertension (AH) was a special focus on initializing antihypertensive treatment with single-pill combinations (SPCs) in majority patients with AH. Combination of the angiotensin II receptor blocker and thiazide diuretic is one of the possible first line SPCs in the absence of specific clinical conditions according to the new guidelines. In this regard, SPC of telmisartan and hydrochlorothiazide (HCT), worth special noticing in the classes of sartans and thiazide diuretics, since both drugs have a long clinical experience and large body of evidence of antihypertensive efficacy and safety, as well as telmisartan also has a number of superior target-organ protective and metabolic properties distinguishing it from other members of the class. In real clinical practice TANDEM study telmisartan and its SPC with HCT showed high antihypertensive efficacy and good tolerability in patients with all AH grades and with isolated systolic AH and allowed to achieve target blood pressure levels in the most of patients. Long-lasting effect is another essential characteristic of telmisartan, this feature allows to control blood pressure throughout the day, including the morning surge, which is the most “dangerous” in terms of cardiovascular risk. Telmisartan also provide powerful target-organ protection realized at the level of all AH target-organs. Finally, another unique pharmacological property of telmisartan and its combination with HCT is a favourable effect on the carbohydrate and lipid profile, which comprises of increasing tissue sensitivity to insulin, normalizing blood glucose levels, reducing blood total cholesterol, low-density lipoprotein cholesterol and triglycerides and thereby reducing risk of atherosclerosis development and progression. Telmisartan/HCT SPC should be recommended for wide use in hypertensive patients to control blood pressure, protect end-organs, improve prognosis and reduce cardiovascular risk due to its high antihypertensive efficacy, the ability to provide the large target-organ protection and a beneficial metabolic effect.

Epidemiology of Arterial Hypertension in Russian Federation - Importance of Choice of Criteria of Diagnosis

Assessment of prevalence of arterial hypertension (AH), need for prescription of antihypertensive therapy (AHT), and efficacy of AHT in Russian population in accordance with novel guideline of the American College of Cardiology/American Heart Association ("American recommendations") on diagnosis and treatment of AH (2017). Epidemiological study ESSE-RF (ЭССЕ-РФ) was carried out in 12 regions of Russian Federation (RF) with different climatic-geographic characteristics. Number of examined residents of RF aged 25-65 years was 20 652. The sample was stratified by gender and age. Examination included anthropometry, laboratory tests, blood pressure (BP) measurement with the OMRON tonometer. The SCORE scale was used for evaluation of risk of development of cardiovascular diseases (CVD). In American recommendations AH was defined as follows: 1-st degree - systolic BP (SBP) 130-139 and/or diastolic BP (DBP) 80-89 mm Hg, 2-nd degree - BP ≥140/90 mm Hg and/or presence of AHT. In recommendations of the European Society of Cardiology (2013, 2018) ("European recommendations") AH was defined as BP ≥140/90 mm Hg and/or presence of AHT. We analyzed data of examination of 20 607 participants - 7806 men (37.9%) and 12 801 women (62.1%). According to European recommendations AH was diagnosed in 10 347 persons (50.2%) - 3987 men (51.1%) men and 6 360 women (49.7%). According to American recommendations AH was registered in 14 853 persons (72.1%) - 6 059 men (77.6%) and 8 794 women (68.7%). AHT received 6324 persons (61.1% of those with AH); according to American recommendations, the onset of AHT was indicated to additional 620 persons with 1-st degree AH because of high CVD risk. Among all participants with AH (on and without AHT) strengthening of AHT for achievement of target BP level was required in 77.8 and 92.6% of patients according to European and American recommendations, respectively. Application of novel criteria of AH diagnosis from 2017 ACC/AHA guideline to Russian population would increase prevalence of AH up to 72.1%. Onset of AHT would be indicated in 13.8% of patients with 1-st degree AH, while in 93% of patients receiving AHT its strengthening would be required.

Pharmacoepidemiological Research of the Efficacy of Fixed Dose Combinations in the Treatment of Patients with Arterial Hypertension in Ambulatory Practice

Aim. To study the pharmacoepidemiological features of the prescription of antihypertensive fixed dose combinations and their efficacy in hypertensive patients in the real outpatient practice in Vladivostok city. Material and methods . Hypertensive patients aged 1 8 years and older (n=268) observed in Vladivostok polyclinics from October to December 2017 were included into the study. All patients did not have target blood pressure (BP) levels. The analysis of the medical prescriptions of antihypertensive fixed dose combinations in Vladivostok polyclinics was performed. Two-component (perindopril + amlodipine) or three-component (perindopril + amlodipine + indapamide) fixed dose combinations were prescribed by physician in accordance with instructions for medical use and their pharmacological characteristics. The study was non-interventional and included 3 visits for the initial examination, prescription and correction of therapy, considering its efficacy. All patients were determined for glomerular filtration rate using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Formula), changes in BP. Patients performed self-esteem on a 1 0-point visual analogue scale (VAS). Results. Only 23.4% of patients reached target BP levels in the first month of observation, and 84.5% of patients after 3 months of observation. 30 (1 1.2%) patients had replacement with double antihypertensive fixed dose to triple combination combinations during the study. 68.6% of patients did not have a replacement for the initial prescribed antihypertensive fixed dose combinations due to the achievement of target BP. The number of patients with moderately and markedly reduced glomerular filtration rate was reduced significantly. Initially, the patients included into the study assessed health (according to adapted VAS) for 5.6±1.4 points, and after 3 months of follow-up - for 7.9±1.7 points. Conclusion. The use of antihypertensive fixed dose combinations containing ACE inhibitor (perindopril), calcium channel blocker (amlodipine) and thiazide-like diuretic (indapamide) resulted in achievement of target BP levels in 84.5% of patients after 3 months of follow-up. Also, the use of double and triple fixed dose combinations had a nephroprotective effect, manifested in an increase in the number of patients ( + 19.3%) with a glomerular filtration rate more than 60 ml/min/1,73 м 2 and a positive effect on the patient's well-being.

Modern Recommendations and Real Clinical Practice: the Results of the SILA Study

Aim . To assess efficacy and safety of single-pill combination (SPC) amlodipine/perindopril and amlodipine/indapamide/perindopril in patients with uncontrolled hypertension (HT) in routine clinical practice. Material and methods . 16144 patients with uncontrolled HT were included into this multicenter observational study. Eventually 6% of patients were excluded owing to violations of protocol. 15193 patients became subjects to the final statistical analysis; they all were prescribed with single-pill combination amlodipine/perindopril or amlodipine/indapamide/perindopril and subsequently purchased these drugs. Study lasted for 3 months; during this time researchers performed office blood pressure (BP) and heart rate measurements on a monthly basis. Additionally, the researchers registered adverse effects and assessed efficacy and safety using 7-point scale. Results. Initially, patients had an average systolic BP of 1 64.2 ± 1 1.4 mm Hg, diastolic BP - 94.8±8.1 mm Hg, and they also had antihypertensive therapy in 85-89% of cases (in different regions). Patients received ACE inhibitors in 50-54% of cases, angiotensin receptor blockers - in 1 9-23%, calcium channel blockers - in 24-31 %, thiazide diuretics - in 29-36%, beta-blockers - in 27-32%. Monotherapy with ACE inhibitors was used in 1 2-18% of patients, and monotherapy with other antihypertensive drugs - in 1 -4%. Mean age was 60.5 years, mean body mass index - 29.3 kg/m 2 , 43% of patients had a very high risk by SCORE scale. Prescribed therapy: SPCs amlodipine/perindopril (54%) and amlodipine/indapamide/ perindopril (46%) in different doses. By the end of treatment course, the following results have been got: 88% of patients achieved target BP levels (92% and 85% among patients who took SPCs amlodipine/perindopril and amlodipine/indapamide/perindopril, respectively). Systolic BP decreased by 36,6±11,4 mm Hg (22.0±5.9%), diastolic BP - by 15.6±8.5 mm Hg (16.0±8.1%), pulse BP decreased by 21.0±11.4 mm Hg (28.8±13.9%). Mean efficacy assessment rate was 6.9±0.37 points out of 7; mean safety assessment rate was 6.9±0.37 points out of 7. Adverse events were recorded in 257 patients, which constituted 1.7% of the entire patients' population. Conclusion. Using SPC amlodipine/perindopril and amlodipine/indapamide/perindopril is associated with fast achievement of the target BP levels among most patients with a small number of adverse effects.

ANICHKOV study: the effect of combined hypotensive and lipid-lowering therapy on cardiovascular complications in patients of high and very high risk.

The aim of the study was to assess cardiovascular risk in patients with elevated levels of total cholesterol and LDL-C and concomitant AH, a comparative analysis of adherence, efficacy and safety of various forms of combined therapy in outpatient practice, including promising lisinopril/amlodipine/rosuvastatin FC (Ekvamer®). The ANICHKOV study included 702 patients in Moscow and the Moscow region over 18 years old with a -chole-sterol level ≥7.5 mmol/l and/or LDL-C ≥4.9 mmol/l from March 2017 to December 2018 based on 2 federal centers. According to the results of visit I, patients were prescribed with one of three therapy schemes. In the absence of AH, patients received scheme I -(Mertenil® at initial dosage of 10 mg/day). When history of AH existed or AH detected at visit I, patients were randomized to scheme II (Ekvamer® 5/10/10 mg/day) or III (Mertenil® 10 mg/day + Ekvator® 5/10 mg/day). During the observation, the treatment scheme remained unchanged, however, if the target levels of LDL-C and/or BP were not reached, the doses could be increased. The analysis of the main effects of the prescribed therapy were carried out for 12 months, and the frequency of MACE (CVD, ACS, stroke, or hospitalization to perform PCI) was also evaluated. Following the visit I, scheme I was assigned to 390 patients (55.6%), scheme II - 190 (27.1%), scheme III - 122 (17.4%). In 147 patients (20.9%), TG level was &gt;2.3 mmol/l, which required additional fenofibrate intake in a dose of 145 mg/day. Adherence level was 89.5%, including scheme I - 91.7%, scheme II - 90.5%, scheme III - only 81.8%. In general, among compliant patients (n = 590), the decrease in TCh level was 41.0%, LDL-C - 47.4%. 16.6% of patients reached target levels of LDL-C &lt;2.5 mmol/l, 5.6% - &lt;1.8 mmol/l. In the fenofibrate subgroup, TG level decrease was 34.6%. During the follow-up period, 47 cases of side effects were observed in 27 patients (4.6%), that did not require modification of therapy. Systolic BP reduction in compliant patients of schemes II and III was 20 mm. Hg (13.1%), diastolic BP - 12 mm. Hg (13.6%), target BP levels (&lt;140/90 mm. Hg) reached 83.7% and 80.8% of patients, respectively, target levels of BP and LDL-C &lt;2.5 mmol/l reached 14.5% and 13.1% of patients, respectively, &lt;1.8 mmol/l - 5.8% and 5.1%, respectively. During the observation period no deaths were recorded, other components of MACE were observed in 38 patients (5.8%), including 27 among compliant patients (4.6%) and 11 among non-compliant (15.9%, p&lt;0.01). In 19 out of 38 patients (50%), hospitalization for routine PCI was the end point, ACS - in 12 (31.6%), and stroke - in 7 (18.4%). The results of the study demonstrated a sufficient hypolipidemic effect and high safety of Mertenil® and Ekvamer®. A higher adherence to the combined preparation than to two monodrugs was noted. Achieving target levels of BP and LDL-C is problematic, which dictates the expediency of using fixed combinations of drugs, especially in primary prevention.

Efficacy and tolerance of Arifam in patients with arterial hypertension over 55 years old: main results of the observational program ARBALET

Aim.To assess the effectiveness and safety of therapy with fixed combination of amlodipine/indapamide (Arifam) in outpatients with arterial hypertension (AH) over 55 years old.Material and methods.We included 2217 patients in the observation — 692 (31%) men and 1521 (69%) women. Changes in the course of 3-month therapy of systolic and diastolic blood pressure (BP), the frequency of achievement of target BP levels (&lt;140/90 mm Hg), responder rate during the clinical and ambulatory blood pressure measurement were evaluated and.Results.With the use of Arifam fixed combination 89,81% of patients achieved target BP level by the 3rd month of treatment, 73,77% of patients achieved positive response in 2 weeks, 94,88% of patients — after 1 month. According to the selfcontrol data, the target BP level (&lt;135/85 mm Hg) was achieved in 79,47% of patients. The number of patients with pulse BP &lt;60 mm Hg increased after 3 months of treatment to 81,97%. Also 48 (2,17%) patients discontinued participation; 6 (0,28%) patients — due to the development of adverse events.Conclusion.The ARBALET program has demonstrated high efficacy and tolerance of using Arifam fixed combination in outpatients over 55 years old with hypertension.

Abstract P346: Impact of the Changing Guidelines in the Classification of Patients: Insights from a Real Life mHealth Digital Registry

Background: The recent updated AHA/ACC guidelines have spiked academic discussions on the changing prevalence of hypertensive subjects with the new thresholds. Aim: To determine the changes in classification (hypertensive or not) on a real life and spontaneous mHealth digital registry, via mobile App and website. Population and Methods: 7956 consecutive subjects (71% males; 53±11 years old) subscribed, spontaneously, a real-time BP -recording, - interpretation and -trend evaluation service (via smartphone-Health App and website platforms). Thru the digital platforms, each BP value, after consistency-checks, feeds a proprietary algorithm providing both individual BP value interpretation in comparison to the previous BP history, and BP trend and fluctuations assessments. These latter are fed back to users on their smartphone and computer screens instantly. The service complies with the most strict data privacy, safety and security requirements. Results: We collected 176432 BP measurements, overall. BP were optimal according to the AHA-ACC guidelines values (&lt;=120/80mmHg) were in 29% of instances, while either only the systolic or the diastolic BP values were optimal in 53% of instances. Conversely, according to the most commonly used normal thresholds of BP &lt;=130/85mmHg 63% of both systolic and diastolic BP values were normal, while either only the systolic or the diastolic BP values were optimal in 39% of instances. Conclusion: In a population of subjects, who subscribed a digital remote BP monitoring and evaluation service because they are so aware of the need of controlling their BP, the change of guidelines threshold for optimal and event reducing BP doubles the impact of non-controlled BP. This registry highlights the wide gaps still existing in achieving target blood pressure levels in real-life subjects, even in the most aware hypertensive subjects.

Realities and prospects of remote blood pressure monitoring in hypertensive patients.

Despite the success in increasing the effectiveness of treatment of arterial hypertension (AH), frequency of achieving target levels of blood pressure (BP) in hypertensive patients and the scope of their regular supervision in most countries of the world, including in the Russian Federation are insufficient. Modern telemedicine technology, involving remote monitoring of blood pressure, have the potential to significantly improve the situation. The analysis in the world of research on this subject showed the presence of benefits and advantages as well as the barriers and disadvantages in comparison with the common practice of monitoring of patients AG. But the overall balance is in favor of this technology. In the Russian Federation in the presence of a single domestic randomized studies of remote monitoring of blood pressure in hypertensive patients currently undergoing a pilot project in seven regions of the country. Practice shows that with proper organization of the work achieved good results in the achievement of target BP levels. To date, in our country, taking into account the accumulated international and domestic experience, the full normative and methodical base, and the availability of affordable hardware, and proven organizational technologies can and should expand the practice of remote blood pressure monitoring in hypertensive patients. This will significantly increase the proportion of hypertensive patients that are under medical supervision, and significantly improve the effectiveness of antihypertensive therapy. Immediate consequence of such practices will reduce the number of calls to urgent and emergency care reduction in the number of trumpeter, and further reducing the number of strokes and myocardial infarctions, and ultimately reducing cardiovascular mortality.

An Open Label, Multi-Center, Non-Interventional Study of the Safety of Nebivolol (Nebilet) In the Treatment of Hypertension in Filipino Adult Patients: A Post Marketing Surveillance Study

Background: Nebivolol is a potent third generation beta-blocking agent indicated for the treatment of hypertension, and is distinguished from other beta blockers by its dual mechanism of action involving high β-1 cardioselectivity and unique nitric-oxide (NO) induced vasodilation. This study aims evaluate the safety and efficacy of Nebivolol (Nebilet) 5mg in the treatment of hypertension among Filipino adult patients. Methods: This is a prospective, open-label, non-interventional study which evaluated the safety of Nebivolol (Nebilet) 5mg in Filipino adult subjects with hypertension, aged 21 to 80 years, in an out-patient setting. Results: A total of 1,154 patients were recruited into the study, 36 (3%) of which had reported adverse events (AEs). Majority of the AEs were due to headaches (18%) and other non-specified events (32%). Most of the adverse events reported were mild to moderate and some were known effects of β- blockers. There were no serious or unsuspected adverse events described during the study. In terms of efficacy, nebivolol reduced blood pressure to less than 140/90 mmHg or a decrease of >10 mm Hg diastolic blood pressure (DBP) in 82% of subjects in the first follow-up visit. At the end of the treatment period, 97% had achieved target blood pressure levels. Conclusions: The study has shown that nebivolol is a safe and effective medication in hypertensive Filipino adult patients.

Arterial hypertension and cerebrovascular diseases in general medicine practice

Cerebrovascular diseases are the second cause in the structure of mortality in our country, and the third – in the world. The most part (96%) of these are chronic cerebrovascular disorder – encephalopathy. The risk of cerebrovascular disease is significantly increased with the existence controlled arterial hypertension for a long time.The main risk factors for the development of hypertensive encephalopathy, which related to the severity and duration of hypertension are uncontrolled hypertension, including «soft» arterial hypertension, hypertensive crises, high blood pressure variability with high night arterial hypertension, episodes of orthostatic hypotension, excessive decline of blood pressure.The risk of a stroke correlates with both the magnitude of systolic and diastolic blood pressure.The principle of treatment of hypertensive encepfalopathy: therapy of hypertension with the appointment of individually selected antihypertensive therapy with the achievement of target values of blood pressure; influence on risk factors for cardiovascular diseases (statins, antiagregants, to give up smoking and others); Improvement of brain perfusion and correction of metabolic disorders in nerve cells that function in conditions of ischemia and hypoxia.The basic principles of antihypertensive therapy in vascular pathology of the brain: it is basic, constant, for life, using modern classes of drugs. The five classes of antihypertensive drugs showed the same effective ness for patients with light hypertension: diuretics, beta blockers, ACE inhibitors, calcium channel blockers, angiotensin II receptor antagonists (advantage – combination therapy, even in the early stages!). It is recommended to achieve target blood pressure levels <140/90 (which reduces the risk of cerebrovascular accident by 1/3). There is the convincing evidence for secondary prevention for ACE inhibitors, sartans, diuretics.The hypertensive encephalopathy is an interdisciplinary problem in general practice so this pathology needs special attention.

Efficiency of triple antihypertensive therapy in patients with uncontrolled hypertension and depressive disorders

To evaluate the efficiency of triple antihypertensive therapy in patients with uncontrolled hypertension and depressive disorders (DD). 153 patients with uncontrolled hypertension were examined, of whom 82 patients were diagnosed with mild and moderate DD. A combination of perindopril 10 mg/day, indapamide SR 1.5 mg/day, and amlodipine at an initial dose of 5 mg/day was given to patients with hypertension and DD. After 4 weeks of treatment, if target blood pressure (BP) levels could not be achieved, the dose of amlodipine was increased up to 10 mg/day. General clinical examination and 24-hour BP monitoring (BPM) were performed in all the patients at baseline and in the patients with DD also after 24 weeks of therapy. The traditional measures of the diurnal BP profile, as well as the parameters characterizing arterial stiffness and central aortic pressure (CAP) were estimated. After 8 weeks of therapy, target BP levels were recorded in 63 (76.8%) patients. After 24 weeks of treatment, the hypertensive patients with DD showed significant positive changes in all the investigated 24-hour BPM parameters and normalization of the diurnal BP profile in 65.1% of cases. During the treatment, there were significant decreases in pulse wave velocity, brachial arterial and aortic augmentation indices, aortic systolic and diastolic pressures, and mean aortic BP and an increase in the velocity of the reflected wave. Triple therapy, including perindopril, indapamide SR, and amlodipine, contributed to the achievement of target BP levels in the majority of hypertensive patients with DD, with significant positive changes in all 24-hour BPM parameters, optimization of the diurnal BP profile in most patients, clinically significant improvement of the parameters that characterize arterial stiffness and CAP.

Arterial hypertension treatment changes in Yaroslavl region: results obtained after 4 years of complex program of regional healthcare system’s improvement implementation

Program’s aim. Cardiovascular morbidity and mortality rates in Russia are among the highest in Europe. The aim of this work was to implement a complex healthcare system improvement program in Russia’s Yaroslavl region, dedicated to increasing arterial hypertension treatment efficacy and prevent complications of arterial hypertension. Materials and methods. The program was developed by a group of healthcare professionals of the Department of Healthcare and Pharmacy of Yaroslavl region together with Novartis Pharma Company’s technical advice within the framework of a private-public partnership. The program consisted of several actions aiming to raise the healthcare system’s attention to hypertension. Achievement of target blood pressure (BP) control by every patient seen by physicians of the Yaroslavl region healthcare system became the main goal and leading criteria for assessing hypertension treatment efficacy. Additionally, significant effort was put into patient education on self-control of BP levels and importance of achieving target BP levels in accordance with Russian national clinical guidelines and on adherence to treatment. Within 4 years, program efficacy was evaluated and reinforced by conducting annual cross-sectional questionnaire-based epidemiological studies. Analysis was performed in a representative sample of patients that evaluated BP control level, mean BP levels, systolic BP level distribution by grades, as well as cardiovascular risk factors and concomitant diseases presence and current antihypertensive therapy. In addition, analysis of official statistics on disease incidence and drug sales databases were performed. Results. From 2011 to 2014 BP control level increased significantly: 17% of patients had BP

Изменения в лечении артериальной гипертензии в Ярославской области: результаты, полученные в результате 4 лет реализации комплексной программы по совершенствованию областной системы оказания медицинской помощи

Program’s aim. Cardiovascular morbidity and mortality rates in Russia are among the highest in Europe. The aim of this work was to implement a complex healthcare system improvement program in Russia’s Yaroslavl region, dedicated to increasing arterial hypertension treatment efficacy and prevent complications of arterial hypertension. Materials and methods. The program was developed by a group of healthcare professionals of the Department of Healthcare and Pharmacy of Yaroslavl region together with Novartis Pharma Company’s technical advice within the framework of a private-public partnership. The program consisted of several actions aiming to raise the healthcare system’s attention to hypertension. Achievement of target blood pressure (BP) control by every patient seen by physicians of the Yaroslavl region healthcare system became the main goal and leading criteria for assessing hypertension treatment efficacy. Additionally, significant effort was put into patient education on self-control of BP levels and importance of achieving target BP levels in accordance with Russian national clinical guidelines and on adherence to treatment. Within 4 years, program efficacy was evaluated and reinforced by conducting annual cross-sectional questionnaire-based epidemiological studies. Analysis was performed in a representative sample of patients that evaluated BP control level, mean BP levels, systolic BP level distribution by grades, as well as cardiovascular risk factors and concomitant diseases presence and current antihypertensive therapy. In addition, analysis of official statistics on disease incidence and drug sales databases were performed. Results. From 2011 to 2014 BP control level increased significantly: 17% of patients had BP<140/90 mm Hg in 2011, 23% in 2012, 32% in 2013 and 33% in 2014. In the same time mean BP level reduced from 151/90 to 145/86 mm Hg and share of patients with systolic BP≥180 mm Hg decreased from 10% to 5%. Stroke incidence declined by 20% (from 4,6 to 3,7 per 1000 adult population in 2011 and 2014 respectively) and antihypertensive drug utilization increased by 16% (2014 vs. 2011). Conclusion. A healthcare system improvement program aiming to increase hypertension treatment efficacy resulted in significant improvement in BP control level and substantial decrease in stroke incidence. Continuous improvement is necessary to increase BP control level further resulting in reduction of cardio-vascular mortality and morbidity in the region. Nationwide system for hypertension drug provision could be an instrument of further improvement.