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Aim: To collect information on the efficiency and safety of a fixed-dose combination of amlodipine/valsartan in patients who failed to achieve blood pressure (BP) control in the use of the combination of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and a thiazide/thiazide-like diuretic., Subjects and Methods: During routine clinical practice, the 12-week observation program covered 8594 hypertensive patients receiving a fixed-dose combination of amlodipine/valsartan 5/160, 10/160 mg (exforge, Novartis Pharma) with/without a diuretic. The inclusion criteria were 18 years of age or older; systolic BP > OR = 140 mm Hg and/or diastolic BP > or = 90 mm Hg) at the first visit; failure to achieve BP (> or = 140/90 mm Hg) control in the use of the combination of an ACE inhibitor or an ARB and a thiazide/ thiazide-like diuretic; a patient's consent to participate in the program. The exclusion criteria were, besides the contraindications given in the drug use instruction, absent. Amlodipine/valsartan 5/160 or 10/160 mg were used after the previous ineffective therapy was discontinued. The patients visited their physician's office every 4 weeks., Results: The patients' baseline BP was 169.3/99.9 mm Hg. The risk of cardiovascular events was assessed as high in 38% of the patients and as very high in 43.1%. The previous therapy included thiazide or thiazide-like diuretics (92%), an ACE inhibitor (78.5%), an ARB (23.2%), beta-adrenoblockers (38.6%), calcium antagonists (23.1%), and other medications (25.5%). In the entire group, BP decreased from 169.3 +/- 15.6/99.9 +/- 9.3 to 129.1 +/- 9.1/80.3 +/- 6.4 mm Hg at the fourth visit. BP reductions at 12 weeks were 40.1 +/- 14.9/19.6 +/- 9.5 mm Hg. The therapy was effective in different treatment subgroups. At baseline, the majority of patients had grades 2 (53.1%) and 3 (35.4%) hypertension. At 12 weeks, 74% of the patients were found to have normal or high normal BP. Grade 3 hypertension was preserved only in 0.2% of the patients by the end of the program. BP goals were achieved in 79.5% of the patients. The therapy was well tolerated by the patients. Adverse reactions were observed in 3.1% of the patients and required treatment discontinuation in 0.5%. The most common side effect was peripheral edemas (1.4%)., Conclusion: In the observation program AESCULAP using the fixed-dose combination of amlodipine/valsartan as different dosage regimens (5/160 and 10/160 mg) and/or a diuretic, there was a marked antihypertensive effect in different subgroups of patients with previously uncontrolled hypertension and the BP goals being achieved in 79.5% of cases. Most patients tolerated amlodipine/ valsartan well and showed high compliance with the prescribed therapy. The rate of side effects in the AECULAP program was not greater than that (3.1%) in the earlier trials.

Aim: To evaluate the efficiency and safety of two treatment regimens using ramipril or losartan in combination with hydrochlorothiazide (HCT) and amlodipine in grade 1-2 arterial hypertension (AH)., Subjects and Methods: The prospective, international, multicenter, randomized, open-label, controlled trial with parallel groups included 347 AH patients in Russia (n = 166), Croatia, and Ukraine. The follow-up was 12 weeks in patients not receiving antihypertensive therapy (AHT) and 13 weeks in those who had previously received AHT with regard to a washout period. The basis for two treatment regimens was ramipril or losartan. If no target blood pressure (BP) was achieved, amlodipine or HCT was added at week 4 and a third antihypertensive drug (AHD) was used 8 weeks later., Results: At the inclusion, clinical BP was 157.64/95.5 mm Hg in 332 (61%) AH patients aged 55.9 +/- 11 years. At week 4 of monotherapy with ramipil 5 mg or losartan 50 mg, BP was reduced to 141.9/87.4 mm Hg. Addition of a second AHD further lowered BP to 131.8/81.9 mm Hg (to 127.6/79.7 at 12 weeks of treatment; p < 0.001). After 4 weeks of treatment with ramipril 5 mg or losartan 50 mg, 35% of the patients achieved target BP. At weeks 8 and 12, double or triple AHT increased the number of patients achieving the target level up to 75 and 94%, respectively. When losartan was used as monotherapy, about one third of the patients achieved target BP; 20 and 22% of the patients required the addition of a second AHD (HCT and amlodipine, respectively). Only 10% of the patients needed to take a combination of three AHDs. Nearly one third of the patients achieved target BP during monotherapy with losartan or ramipril. Double AHT involving ramipril or losartan in combination with the diuretic or amlodipine was used in 18 and 20% and in 22 and 24% of the patients, respectively. 28 and 19% of the patients received triple therapy including ramipril or losartan, amlodipine, and HCT. The most common adverse reactions were dizziness (2.4%), fatigue (1.8%), and coughing (1.2%)., Conclusion: In the patients with grades 1-2 AH, the treatment regimens using basic therapy with ramipril or losartan proved to be highly effective and allowed target BP to be achieved in 94% of cases. Both treatment regimens were comparable in view of safety; slight side effects occurred rarely (in less than 2.5% of the patients) and required that the treatment should not be discontinued.

Introduction: The aim of our study was to evaluate the safety and effectiveness of the free combination of amlodipine/valsartan in patients with arterial hypertension in a real-life setting., Methods: This was a multicenter, open-label, observational, noninterventional, postmarketing surveillance study conducted in 298 centers in China, Malaysia, Pakistan, Bangladesh, Egypt, and Russia. We evaluated changes in heart rate, systolic and diastolic office blood pressure (BP), as well as BP control rate (<140/90 mmHg) overall, and in clinically relevant subgroups of hypertensive patients (BP >140/90 mmHg) after 12 weeks of treatment with 5/10 mg amlodipine and 80/160 mg valsartan combination., Results: Two thousand seven hundred and eighty-five patients with arterial hypertension were enrolled, 52 discontinued (eight due to adverse events), and four patients' data were missing. In total, 2729 patients completed the study: mean age 57.9 years, 54.5% men, 54.2% Asian, 44.6% Caucasian; 86.5% had prior hypertension treatment (which was discontinued), baseline BP was 163.1/96.2 mmHg. The significant reduction in BP (-33.2/-16.9 mmHg, P<0.0001) was achieved with amlodipine/valsartan treatment resulting in a final BP of 129.9/79.3 mmHg. A dose-dependent effect was observed with the least BP reduction for 5/80 mg (-29.2/-15.1 mmHg, P<0.0001) and the greatest for the 10/160 mg dose regimen (-43.6/-22.4 mmHg, P<0.0001). Treatment response increased with increasing initial severity of hypertension with the least BP reduction in patients with baseline grade 1 hypertension BP level (SBP 140-159 mmHg): -20.0/-13.4 mmHg, P<0.0001, and the greatest BP drops observed in grade 3 hypertensive patients with baseline systolic BP over 200 mmHg: -73.1/-26.3 mmHg, P<0.0001. Patients with isolated systolic hypertension had BP reductions of -24.2/-4.8 mmHg, P<0.0001., Conclusion: An optimal BP reduction was achieved for all hypertension grades as well as isolated systolic hypertension, providing evidence that most hypertensive patients may benefit from amlodipine/valsartan combination treatment.

Aim: To assess efficacy of two- and three-component antihypertensive treatment (AHT) in patients with severe sleep apnea and arterial hypertension (AH) of the second and third degree in combination with CPAP therapy (continuous positive air pressure) and without it., Material and Methods: A total of 58 patients aged 55.5 +/- 9.6 years participated in the study. Clinical blood pressure (BP) before treatment was 172.0 (170.7-175.9)/100.0 (98.5-104.2) mm Hg, apnea/ hypopnea index was 26.3 episodes an hour. The patients received amlodipin in combination with walsartan in a dose 5-10/160 mg with addition of 25 mg hydrochlorothiaside if target BP was not achieved. This treatment was followed for 3 weeks by CPAP-therapy. Monitoring was made of clinical BP, central BP, target mean 24-h pressure., Results: Despite a significant reduction of systolic arterial pressure/diastolic arterial pressure (by 30/14 mm Hg) as a result of antihypertensive treatment, this reduction was lower than in such patients without obstructive sleep apnea (by data from other investigators). CPAP-therapy reduced the number of resistant patients from 58 to 31%, patients with masked AH--from 19 to 11%, cases of arrhythmia--from 69 to 47%., Conclusion: Multicomponent pathophysiologically sound AHT in hypertensive patients with severe obstructive sleep apnea was effective in less than 42% cases. The maximal effect was achieved in combined treatment with CPAP-therapy.

Aim: To investigate antihypertensive efficacy and safety of a fixed combination of ACE inhibitor enalapril with thiaside diuretic drug hydrochlorothiaside (HCT) in hypertensive patients with a high and very high risk of cardiovascular complications., Material and Methods: The trial has covered 7796 hypertensive patients from 28 cities (42 clinics) of Russia, Ukraine, Belarus and Georgia. All the patients had a high and very high risk of cardiovascular complications. The protocol provides for measurements of clinical arterial pressure, 24-h monitoring of arterial pressure. Diabetic patients' plasma was examined for glucose concentrations. All the patients received enalapril in combination with HCT in doses from 10/6.25 to 40/25 mg/day for 3 months., Results: After 3 month treatment target systolic arterial pressure (SAP) was achieved in 81% patients, diastolic pressure (DAP)--in 88%, by SAP and DAP--77%. By 24-h blood pressure monitoring, 24-h, diurnal and nocturnal blood pressure significantly decreased in 60 patients. Target 24-h blood pressure was achieved in 78% patients. Pressure load parameters lowered significantly for SAP and DAP for 24 hours, diurnal and nocturnal pressure. Glucose levels in patients with diabetes mellitus (n = 1263) diminished from 7.3 to 6.4 mmol/l (p < 0.0001)., Conclusion: A fixed combination of enalapril with HCT was effective in hypertensive patients with a high and a very high risk of cardiovascular complications. It provided a target level of blood pressure in 77% patients and significantly reduced SAP, DAP and PAD.

Unlabelled: Investigation of the dynamics of heart rate variability (HRV) in anti-hypertension therapy can facilitate the evaluation of the effectiveness of treatment., Aim of Investigation: to compare anti-hypertension effect of monotherapy with nebivolol and dilatrend with dynamics of HRV and the estimation of the state of patients with mild arterial hypertension (AH) and metabolic syndrome (MS)., Material and Methods: HRV was studied in 42 patients with mild AH and MS at the age of 32-60. Eighteen of them were treated with 5 mg of nebivolol during 24 weeks, and twenty-four with 25-50 mg of dilatrend during 16 weeks. All the patients were subjected to 24-hour ECG monitoring with analysis of HRV and arterial pressure (AP) before and after treatment. The main feature of HRV analysis was investigation of dependence of sinus arrhythmia on the mean value of heart rate (HR) RESULTS: With nebivolol treatment AP decreased in 11 patients, HRV became better in 9 patients. 7 cases manifested coincidence of AP reduction and HRV improvement. In 6 cases out of 7 when AP did not decrease, HRV did not change. Worsened HRV was observed in 3 cases: in one case with growing AP and in 2 cases with decreasing AP. All the patients, except one, regarded their state as improved. With dilatrend treatment AP lowered in 16 cases. In 9 cases HRV became better, in 11 cases it remained the same, and in 4 cases it became worse. Positive HRV dynamics in 7 cases out of 9 was accompanied by lowering of AP, while negative dynamics was observed in one case with rise of AP and in three cases with very low AP or in the absence of AP dynamics. 14 patients felt better, 6 of them manifested better level both of AP and HRV., Conclusion: The method of 24-hour HRV analysis based on assessment of dependence of the value of sinus arrhythmia on HR is useful in evaluating the effectiveness of anti-hypertension therapy. As a rule, an effective decrease in AP is accompanied with improvement of HRV. The absence of improvement of deterioration of HRV in anti-hypertension therapy is a factor which should be taken into consideration when choosing the mode of therapy.

Aim: To study structural and functional changes in left ventricular myocardium (LVM) of patients with mild and moderate arterial hypertension (AH) with application of tissue myocardial dopplerechocardiography (TMD), correlation between these changes and parameters of electrophysiological remodeling and circadian profile of blood pressure., Material and Methods: Forty-give hypertensive patients were divided into two groups: the study group 2A consisted of 28 patients with mild AH (144.2 +/- 5.8/89.4 +/- 6.6 mm Hg), group 2B - of 17 patients with moderate AH (160.5 +/- 9.1/101.3 +/- 10.2 mm Hg). The control group consisted of 10 normotensive subjects. All the patients were examined using standard echocardiography with assessment of transmitral blood flow, tissue doppler investigation, circadian monitoring of blood pressure, electro-, vector- and decartocardiography., Results: No significant differences in standard doppler, electro- and vectorcardiographic parameters between the patients with mild and moderate hypertension were found. LVM mass index and LV wall relative thickness significantly increased both in 2A and 2B groups vs controls (p < 0.05). Most patients of group 2A and 50% patients of group 2B had no alterations in LV geometry. Lower blood pressure was associated with LV concentric remodeling, higher - with concentric and excentric hypertrophy. In the presence of LV remodeling hypertensive patients developed more pronounced disorders of diastolic function according to TMD compared to hypertensive patients with normal LV geometry (p < 0.05). TMD detected LV diastolic disorders in 82% patients of group 2A and in 94% - of group 2B, while transmitral doppler study detected diastolic dysfunction only in 14 and 29% patients, respectively. A significant difference by Em/Am was registered between patients with mild and moderate AH only in the area of the mitral ring at the side of LV posterior wall (p < 0.05)., Conclusion: TMD is able to detect earleast structural-functional myocardial changes in hypertensive patients and to determine significant differences in LV diastolic disorders in patients with mild and moderate AH. No significant differences in LVM mass, standard doppler, electro- and vector-cardiographic parameters were found between AH patients' groups.

Background: The aim of this study was to assess the effects of continuous positive airway pressure (CPAP) on arterial stiffness, central blood pressure, and reflected pulse wave characteristics in patients with severe obstructive sleep apnea (OSA) and stage 2-3 arterial hypertension.Methods: Forty-four patients with hypertension and severe OSA (apnea/hypopnea index > 30) received stepped dose titration of antihypertensive treatment, consisting of valsartan 160 mg + amlodipine 5-10 mg + hydrochlorothiazide 25 mg. CPAP therapy was added after 3 weeks of continuous antihypertensive treatment with BP < 140/90 mmHg or after adjusting triple treatment in patients with resistant arterial hypertension. The patients were randomized to effective CPAP (4-15 mm H2O) or placebo CPAP (pressure 4 mm H2O) for three weeks, then crossed over to the alternative treatment in a single-blind manner. Office blood pressure (BP), ambulatory BP monitoring, ambulatory arterial stiffness index (AASI), aortic BP, carotid-femoral pulse wave velocity (cfPWV), and systolic wave augmentation index were measured using a Sphygmocor® device at baseline, after antihypertensive treatment, placebo CPAP, and effective CPAP.Results: Baseline cfPWV was above the normal range in 94% of patients. After reaching target BP, the cfPWV decreased by 1.9 ± 1.0 msec (P = 0.007). Effective CPAP achieved a further cfPWV reduction of 0.7 msec (P = 0.03). Increased arterial stiffness (pulse wave velocity > 12 msec) persisted in 35% of patients on antihypertensive treatment and effective CPAP, in 56% of patients on antihypertensive treatment alone, and in 53% of patients on placebo CPAP. Only the combination of antihypertensive treatment with effective CPAP achieved a significant reduction in augmentation index and AASI, along with a further reduction in aortic and brachial BP.Conclusion: Effective CPAP for 3 weeks resulted in a significant additional decrease in office BP, ambulatory BP monitoring, central BP, and augmentation index, together with an improvement in arterial stiffness parameters, ie, cfPWV and AASI, in a group of hypertensive patients with OSA. [ABSTRACT FROM AUTHOR]