Previous Antihypertensive Treatment Research Articles

EVALUATION OF THE EFFICACY AND TOLERABILITY OF A FIXED DOSE COMBINATION OF AMLODIPINE AND INDAPAMIDE IN PATIENTS OLDER THAN 55 YEARS

Objective: There is very limited real-life data on hypertension management in Bangladeshi population. Considering this fact, this study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in Bangladeshi patients over the age of 55 years, in an OPD setting with uncontrolled systolic hypertension in real-life clinical practice. Methods: This was a 3-month, multicenter, observational, open-label study conducted in 3 divisional cities of Bangladesh among patients with grade I or II hypertension who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP (< 140 mmHg) achievement at 2 weeks, 1 month and 3 months, in four age groups: 55-59 years, 60-69 years, 70-79 years, and 80 years or older. Design and method: The COMBINE study recruited 213 patients, of whom 185 took indapamide/amlodipine 1.5/5 mg SPC fora full three-month course of therapy. Mean age was 62.4±7.4 years, 76 men [41.1%] and 109 women [58.9%]. The absolute decrease of SBP during 3 months of taking indapamide/amlodipine single-pill combination (SPC) was 29.3 mm Hg, DBP - 12.9 mm Hg. After 3 months of treatment significant SBP decreases from baseline were observed in each age group: ? 31.8 mmHg (from 156.7 to 124.9), ? 26.4 mmHg (from 152.7 to 126.3), ? 29.5 mmHg (from 152.8 to 123.3), and ? 25.8 mmHg (from 151.7 to 125.9) in the 55-59, 60-69, 70-79, and 80 years and older age groups, respectively. Leg edema was observed in 3 patients (1.62%), electrolyte imbalance was observed in 4 patients (2.16%) and 1 patients observed sudden fall of blood pressure. Conclusion: This COMBINE study results showed that indapamide/amlodipine SPC was associated with significant and rapid reductions in BP even in a different age range of Bangladeshi patients in routine clinical practice. This study result is consistent with already achieved data of this SPC globally.

Effects of CBD supplementation on ambulatory blood pressure and serum urotensin-II concentrations in Caucasian patients with essential hypertension: A sub-analysis of the HYPER-H21-4 trial

HYPER-H21–4 was a randomized crossover trial that aimed to determine if cannabidiol (CBD), a non-intoxicating constituent of cannabis, has relevant effects on blood pressure and vascular health in patients with essential hypertension. In the present sub-analysis, we aimed to elucidate whether serum urotensin-II concentrations may reflect hemodynamic changes caused by oral supplementation with CBD. The sub-analysis of this randomized crossover study included 51 patients with mild to moderate hypertension that received CBD for five weeks, and placebo for five weeks. After five weeks of oral CBD supplementation, but not placebo, serum urotensin concentrations reduced significantly in comparison to baseline (3.31 ± 1.46 ng/mL vs. 2.08 ± 0.91 ng/mL, P < 0.001). Following the five weeks of CBD supplementation, the magnitude of reduction in 24 h mean arterial pressure (MAP) positively correlated with the extent of change in serum urotensin levels (r = 0.412, P = 0.003); this association was independent of age, sex, BMI and previous antihypertensive treatment (β ± standard error, 0.023 ± 0.009, P = 0.009). No correlation was present in the placebo condition (r = −0.132, P = 0.357). In summary, potent vasoconstrictor urotensin seems to be implicated in CBD-mediated reduction in blood pressure, although further research is needed to confirm these notions.

Evaluation of the Efficacy and Tolerability of a Fixed Dose Combination of Amlodipine And Indapamide in Patients Older Than 55 Years

Background: There is very limited real-life data on hypertension management in Bangladeshi population. Considering this fact, this study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in Bangladeshi patients over the age of 55 years, in an OPD setting with uncontrolledsystolic hypertension in real-life clinical practice. Methods: This was a 3-month, multicenter, observational, open-label study conducted in 3 divisional cities of Bangladesh among patients with grade I or II hypertensions who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP (&lt; 140 mmHg)achievement at 2 weeks, 1 month and 3 months, in four age groups: 55–59 years, 60–69 years, 70–79 years, and80 years or older. Results: The COMBINE study recruited 213 patients, of whom 185 took indapamide/amlodipine 1.5/5 mg SPC forafull three-month course of therapy.Mean age was 62.4±7.4 years, 76 men [41.1%] and 109 women [58.9%]. The absolute decrease of SBP during 3 months of taking indapamide/amlodipine single-pill combination (SPC) was 27.7 mm Hg, DBP - 10.2 mm Hg.After 3 months of treatment significant SBPdecreases from baseline were observed in each age group:”29.9 mmHg (from 156.7 to 126.8),”25.1 mmHg (from 152.7 to 127.6),”26.1 mmHg (from 152.8 to 126.7),and “ 24.5 mmHg (from 151.8 to 127.3)in the 55–59, 60–69, 70–79, and 80 years and older age groups, respectively. Conclusion: This COMBINE study results showed that indapamide/amlodipine SPC was associated with significant and rapid reductions in BP even in a different age range of Bangladeshi patients in routine clinical practice. This study result is consistent with already achieved data of this SPC globally. Bangladesh J Medicine 2023; Vol. 34, No. 2(1) Supplement: 200

PS-C17-9: RELEVANT BLOOD PRESSURE REDUCTION WITH ORAL SEMAGLUTIDE IN PATIENTS WITH TYPE 2 DIABETES AND OBESITY, INDEPENDENT OF PREVIOUS ANTIHYPERTENSIVE TREATMENT

Objective: The antihypertensive effect of oral semaglutide is apparently modest in published trials but it has not been explored in uncontrolled hypertensive patients. We sought to assess whether oral semaglutide may elicit a clinically relevant reduction of systolic blood pressure (SBP) in patients with type 2 diabetes (T2D), obesity and uncontrolled hypertension, and whether the attained SBP reduction is diluted by the previous antihypertensive treatment. Design and Methods: Retrospective analysis of the SBP and antihypertensive medication data were performed in consecutive patients with T2D and obesity who started therapy with oral semaglutide. Data were obtained from a baseline visit in which oral semaglutide was initiated, and a second visit after 3–4 months. Patients who initiated or changed antihypertensive medication simultaneously with oral semaglutide were excluded. Consent for anonymous analysis and reporting of data were obtained from all included subjects. Results: 50 patients with T2D (by usual clinical criteria) and obesity (BMI &lt; 30 kg/m2) were included; their age was 56 ± 11 years. 32 (64%) were female, and their diabetes duration was 6.9 ± 2.9 years. 41 (82%) of them were diagnosed with hypertension (sitting office SBP &gt; 140 and/or taking antihypertensive drugs). Globally there was a significant but modest reduction in SBP (149.8 ± 11.7 to 146.7 ± 12.4 mmHg, p = 0.041, paired t-test), but this reduction was strongly correlated with the baseline SBP (Pearson's r 0.39, p &lt; 0.001). In the Figure (A) the reductions in SBP for patients with controlled SBP (&lt; 140 mmHg), stage 1 (SBP 140–159 mmHg), stage 2 (160–179 mmHg) and stage 3 hypertension (&gt; 180 mmHg) are shown (p = 0.0056 for differences among SBP categories, one-way ANOVA). The Figure (B) also shows the reductions in SBP for patients taking 0, 1, 2 or &gt; 3 different antihypertensive drugs, but there are no significant differences (p = 0.2312, one-way ANOVA). In the second visit the number of patients with SBP &lt; 140 mmHg had increased from 19 (38%) to 25 (50%). Conclusions: Treatment with oral semaglutide in patients with T2D, obesity and uncontrolled hypertension elicits a clinically significant decrease in SBP, enough to bring about acceptable SBP control in a relevant fraction. As expected, the reduction in SBP was strongly dependent on the baseline SBP. Interestingly, this reduction does not seem to be diluted by the use of multiple antihypertensive drugs, suggesting that oral semaglutide could be considered as an add-on in patients with apparent resistant hypertension.

CLINICAL EFFICACY AND SAFETY OF AMLODIPINE/BISOPROLOL/PERINDOPRIL SINGLE-PILL AND FREE COMBINATION THERAPY IN PATIENTS WITH UNCONTROLLED ESSENTIAL HYPERTENSION

Objective: Efficacy and safety of the triple therapy amlodipine 5 mg, bisoprolol 5 mg and perindopril 5 mg in single pill combination (SPC) and in free combination, over a 12-week period. Design and method: Multicenter, randomized, open-label, controlled, phase III study. Patients with uncontrolled hypertension (Systolic Blood Pressure (SBP) &gt; = 140 and &lt; 160mmHg and Diastolic Blood Pressure (DBP) &gt; = 90 and &lt; 100 mmHg) treated either by monotherapy at maximal dose or bitherapy at initial dose were randomized to the SPC (group A), or to the free combination (group B). Previous antihypertensive treatment was discontinued. Efficacy assessments: SBP, DBP, response to treatment (rate of patients with BP normalized and/or decrease of SBP &gt; = 20 mmHg and/or decrease of DBP &gt; = 10 mmHg from baseline) and BP control rate (SBP &lt; 140 mmHg and DBP &lt; 90 mmHg). Patient-reported outcomes were evaluated using the TSQM-9 (Treatment Satisfaction Questionnaire for Medication) to assess treatment effectiveness, convenience and global satisfaction at the end of the study. Results: 150 patients were randomized (mean age 55.2 ± 10.1 years). At baseline, mean SBP/DBP in the included population were 149.71 ± 5.09/94.92 ± 2.78 mmHg. After 12 weeks of treatment, important SBP/DBP decrease was observed in both groups (-22.01 ± 10.04/-13.79 ± 7.47 mmHg in group A and -21.81 ± 9.41/-15.06 ± 8.31 mmHg in group B). High response to treatment was observed in both groups (90.91% in group A, 93.06% in group B) but higher proportion of patients were controlled with SPC (91.89% in group A, 87.5% in group B). Treatments were well tolerated. Less treatment-related adverse events were reported in group A (1.3%) versus in group B (6.9%). Most of the patients were satisfied with treatment in both groups, with a better convenience for the group A. Conclusions: In case of uncontrolled BP despite monotherapy at maximal dose or bitherapy at initial dose, switching to triple therapy of amlodipine 5mg+bisoprolol 5mg+perindopril 5 mg leads to a significant decrease of BP (p &lt; 0.001), an improvement of response to treatment and better BP control rate. For similar efficacy, treatment by SPC showed lower rate of treatment-related adverse events and was assessed as more convenient by patients as compared to free combination.

Effectiveness of indapamide/amlodipine single-pill combination in patients with isolated systolic hypertension: post-hoc analysis of the ARBALET study

BackgroundThis study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in outpatients with uncontrolled isolated systolic hypertension (ISH) aged over 55 years in real-life clinical practice.MethodsThis was a post-hoc analysis of the subgroup of patients with ISH from ARBALET, a 3-month, multicenter, observational, open-label study conducted in Russia among patients with grade I or II hypertension who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP (< 140 mmHg) achievement at 2 weeks, 1 month and 3 months, in four age groups: 55–59 years, 60–69 years, 70–79 years, and 80 years or older.ResultsThe ARBALET study recruited 2217 patients, of whom 626 had ISH and were included in this post-hoc analysis (mean age 66.1 ± 7.8 years; 165 men [26.4%] and 461 women [73.6%]). Target SBP < 140 mmHg was achieved in 43%, 75% and 93% of patients at 2 weeks, 1 and 3 months, respectively. SBP decreased from baseline by 18.8 ± 10.5 mmHg, 27.2 ± 10.6 mmHg and 31.8 ± 9.9 mmHg at 2 weeks, 1 month and 3 months, respectively. In the groups of patients aged 55–59, 60–69, 70–79, and ≥ 80 years, SBP reductions at 3 months compared with baseline were − 30.3 ± 9.4, − 32.4 ± 9.7, − 32.5 ± 10.7, and − 28.9 ± 9.6 mmHg, respectively.ConclusionThis post-hoc analysis of the observational ARBALET study showed that indapamide/amlodipine SPC was associated with significant reductions in BP and high rates of target BP achievement in a broad age range of patients with ISH treated in routine clinical practice.Study registration numberISRCTN40812831.

BNP LEVELS AND LEFT VENTRICULAR MORPHOLOGY AND FUNCTION IN HYPERTENSIVE PATIENTS BEFORE AND AFTER AN INTRAVENOUS SALINE LOAD

Objective: Previous studies have reported a relationship between BNP levels and left ventricular (LV) morphology and function in essential hypertension (EH), but results are conflicting. The aim of the study was to investigate the relationships between BNP levels measured before and after a standard saline load (SLT), plasma aldosterone (PA), active renin (AR), and LV variables in EH patients without heart failure or valvular disease. Design and method: In 155 EH patients (age 48 ± 12 years, 92 males, 64 treatment-naïve, the remaining 91 after drug wash-out), a SLT (0.9% saline, 2 L in 4 hours) was performed with baseline and post-SLT measurement of PA, AR, BNP pre- and post-test (pre-BNP, post-BNP). Echocardiography with Tissue Doppler Imaging (TDI) was performed, with measurement of indexed LV mass (LVMI), ejection fraction (EF), TDI-S velocity, E/A and E/e’ ratios, and TDI-e’ velocity. Results: Pre-BNP level was higher in females than males, and in patients with previous antihypertensive treatment than in naive patients. Pre-BNP level was significantly and directly related to age, LVMI, E/e’, and inversely related to glomerular filtration (GFR), AR, TDI-S, E/A, and TDI-e’. Post-BNP levels was higher in females and in previously treated patients, and it was positively related to age, E/e’ ratio, and inversely related to GFR, AR, TDI-S, E/A, and TDI-e’. At multivariate analysis pre-BNP level was independently associated with age, female gender, GFR, and AR, while post-BNP level was independently associated with age, AR, and previous antihypertensive treatment. Conclusions: In EH patients, plasma BNP is related with LVMI and LV systolic and diastolic function before and after a SLT, but this relationship seems to be limited to female sex and older subjects. Measurement of BNP might be useful for identification and follow-up of subclinical LV abnormalities in these patients.

2019 Chinese guideline for the management of hypertension in the elderly.

1.1. Class of recommendations and level of evidences The class of recommendations and level of evidences are listed in the Tables 1 & 2. Table 1. Class of recommendations. Classes of recommendations Definitions Suggested wording to use Class I Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective. Is recommended/is indicated. Class II Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of the given treatment or procedure. Class IIa Weight of evidence/opinion is in favor of usefulness/efficacy. Should be considered. Class IIb Usefulness/efficacy is less well established by evidence/opinion. May be considered. Class III Evidence or general agreement that the given treatment or procedure is not useful/effective, and in some cases may be harmful. Is not recommended. Open in a separate window Table 2. Levels of evidences. Level of evidence A Data derived from multiple randomized clinical trials or meta-analyses. Level of evidence B Data derived from a single randomized clinical trial or large non-randomized studies. Level of evidence C Consensus of opinion of the experts and/or small studies, retrospective studies, registries. Open in a separate window 1.2. Definition and categories of hypertension in the elderly Hypertension in the elderly is defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg measured three times in different days among patients aged ≥ 65 years without any previous antihypertensive drugs treatment. If elderly patients have hypertension history, and they are now receiving antihypertensive drugs therapy, they should be diagnosed with hypertension in the elderly though the blood pressure (BP) < 140/90 mmHg. The categories of geriatric hypertension are the same with the categories of hypertension in adults (Table 3). Table 3. Categories of BP and definitions of hypertension grade in the elderly.[1] Categories SBP, mmHg DBP, mmHg Optimal < 120 and < 80 High Normal 120–139 and (or) 80–89 Hypertension ≥ 140 and (or) ≥ 90 Grade 1 hypertension 140–159 and (or) 90–99 Grade 2 hypertension 160–179 and (or) 100–109 Grade 3 hypertension ≥ 180 and (or) ≥ 110 Isolated systolic hypertension ≥ 140 and < 90 Open in a separate window BP category is defined by the highest level of BP, whether systolic or diastolic. Isolated systolic hypertension is graded according to SBP values. BP: blood pressure; DBP: diastolic blood pressure; SBP: systolic blood pressure.

Phaco-non-penetrating deep sclerectomy in ocular hypertension secondary to dexamethasone intravitreal implant

Abstract Purpose To evaluate the characteristics and progression of patients treated with a 0.7 mg dexamethasone intravitreal implant (Ozurdex®) and required glaucoma filtering surgery (phaco-non-penetrating deep sclerectomy) to control ocular hypertension (OHT). Methods A retrospective observational study including patients treated with Ozurdex® in a tertiary-care university hospital from May 2011 to April 2016. Results In five years of follow-up, 1.10% (4/363) of patients treated with 0.7 mg dexamethasone intravitreal implant required phaco-non-penetrating deep sclerectomy (PNPDS) to control OHT refractory to topical treatment. All four patients started or increased previous antihypertensive topical treatment since the first dexamethasone intravitreal implant. Three or more dexamethasone intravitreal implants were injected in the four cases before intraocular pressure (IOP) became uncontrolled and PNPDS was performed. All four patients have a successfully controlled IOP without treatment after PNPDS. Two patients required additional treatment with dexamethasone intravitreal implants after PNPDS, maintaining IOP under control without treatment. Conclusions To the best of our knowledge, this is the first study describing the successful results of PNPDS in OHT secondary to dexamethasone intravitreal implant. All four patients have achieved controlled IOP without treatment. Re-treatment with dexamethasone intravitreal implant in those patients who underwent PNPDS is also possible, and IOP remains controlled.

Faco-esclerectomía profunda no perforante como tratamiento de la hipertensión ocular secundaria al implante intravítreo de dexametasona

PurposeTo evaluate the characteristics and progression of patients treated with a 0.7mg dexamethasone intravitreal implant (Ozurdex®) and required glaucoma filtering surgery (phaco-non-penetrating deep sclerectomy) to control ocular hypertension (OHT). MethodsA retrospective observational study including patients treated with Ozurdex® in a tertiary-care university hospital from May 2011 to April 2016. ResultsIn five years of follow-up, 1.10% (4/363) of patients treated with 0.7mg dexamethasone intravitreal implant required phaco-non-penetrating deep sclerectomy (PNPDS) to control OHT refractory to topical treatment. All four patients started or increased previous antihypertensive topical treatment since the first dexamethasone intravitreal implant. Three or more dexamethasone intravitreal implants were injected in the four cases before intraocular pressure (IOP) became uncontrolled and PNPDS was performed. All four patients have a successfully controlled IOP without treatment after PNPDS. Two patients required additional treatment with dexamethasone intravitreal implants after PNPDS, maintaining IOP under control without treatment. ConclusionsTo the best of our knowledge, this is the first study describing the successful results of PNPDS in OHT secondary to dexamethasone intravitreal implant. All four patients have achieved controlled IOP without treatment. Re-treatment with dexamethasone intravitreal implant in those patients who underwent PNPDS is also possible, and IOP remains controlled.

LOW FIXED-DOSES COMBINATION PERINDOPRIL/INDAPAMIDE/AMLODIPINE -EFFECTS IN GRADE 2 HYPERTENSIVES NOT ADEQUATELY CONTROLLED

Objective: Hypertension is worldwide spread, affects 40.41% of Romanians, and represents the leading cause of death. High blood pressure is associated with left ventricular hypertrophy and diastolic dysfunction. In 15–20% of patients with hypertension a combination of three drugs is needed to achieve blood pressure control, better in a single tablet with fixed doses, because the single-tablet formulation improves adherence, witch is low. The most rationale combinations appear to be a blocker of renin-angiotensin system, a calcium antagonist and a diuretic. The aim of our study was to evaluate the efficacy of low fixed-doses combination perindopril/indapamide/amlodipine 5/1.25/5 mg on blood pressure, left ventricular hypertrophy, and diastolic dysfunction in patients with primary grade 2 hypertension who did not reach the blood pressure goal (< 140/90 mmHg) with previous antihypertensive treatment. Design and method: We performed a prospective study, lasting 3 months, in which 46 treated, but not controlled, grade 2 hypertensives, medium age 55 ± 6 years, received in the evening, low fixed-doses combination perindopril/indapamide/amlodipine 5/1.25/5 mg. Office blood pressure was measured at baseline, 1 month and 3 months. Left ventricular echocardiographic parameters ware measured at baseline and after 3 months of treatment. We assessed patient general condition (well-being) as excellent, improved, appropriate or worse at baseline and after 3 months. Results: Blood pressure was significantly reduced by treatment, both systolic (164 ± 15 vs 138 ± 11 mmHg, p < 0.01) and diastolic (95 ± 9.5 vs 84 ± 7 mmHg, p < 0.01). LVMI was decreased from131.5 ± 19 to 111.3 ± 12.8 g/m2 (p < 0.001). E/A ratio increased from 0.84 ± 0.25 to 1.01 ± 0.14 (p < 0.002). After 3 months of therapy, patient well-being was rated as excellent in 71.74%, improved in 17.40%, appropriate in 10.86% and worse in 0%. Conclusions: Switching patients with uncontrolled grade 2 hypertension to low fixed-doses combination perindopril/indapamide/amlodipine 5/1.25/5 mg allowed to reach the target blood pressure value, with regression of cardiac hypertrophy and improvement in LV diastolic function. Treatment was well tolerated.

NEW ANGIOTENSIN II RECEPTOR BLOCKER FIMASARTAN IN MILD-TO-MODERATE HYPERTENSION: POST-HOC ANALYSIS OF RESULTS OF REGISTRATION TRIAL IN RUSSIA

Objective . We performed post-hoc analysis of results of multicenter open-label randomized comparative trial on antihypertensive efficacy and safety of fimasartan and losartan in parallel groups for adult outpatients with mildto-moderate hypertension (HTN) during 12 weeks of treatment in order to determine characteristics associated with better treatment efficacy. Design and methods. Post hoc analysis included ITT (intention-to-treat) population: 89 patients from fimasartan group and 90 patients from losartan group. We assessed associations between change from baseline in “office” sitting systolic and diastolic blood pressure and gender, age, anthropometric parameters, duration and severity of hypertension, previous antihypertensive treatment, clinical and laboratory parameters on study visits, and doses of studied drugs. Statistical package R (version 3.0.2, The R Foundation for Statistical Computing 2013) was used for analysis. Results . Fimasartan and losartan provided comparable blood pressure lowering effect in gender, age subgroups, in patients with different duration and severity of hypertension, risk factors profiles. There was a trend toward higher blood pressure decrease in patients with body mass index (BMI) ≥ 30 kg/m 2 in fimasartan group. In the overall population BMI ≥ 30 kg/m 2 was associated with 2-fold increase of risk of dose change at any visit: odds ratio (OR) = 2,1 (95 % confidential interval (CI): 1,08–3,91). However, study groups analysis demonstrated that it was true only for losartan: OR = 2,75 (95 % CI: 1,1–6,88; р = 0,036). Fimasartan was equally effective in both obese and normal weight patients: OR = 1,50 (95 % CI: 0,63–3,93; р = 0,356). Conclusions. Hypertensive patients with BMI ≥ 30 kg/m 2 may benefit more from fimasartan treatment. This fact needs confirmation in further studies with larger sample size.

Adherence to Treatment, Safety, Tolerance, and Effectiveness of Perindopril/Amlodipine Fixed-Dose Combination in Greek Patients with Hypertension and Stable Coronary Artery Disease: A Pan-Hellenic Prospective Observational Study of Daily Clinical Practice.

Initiation of antihypertensive therapy with a two-drug fixed-dose combination (FDC) in a single tablet may be recommended in patients at high risk of cardiovascular events to improve adherence and effectiveness. Preferred combinations include an angiotensin-converting enzyme inhibitor with a dihydropyridine calcium antagonist. This study assessed adherence to and the safety, tolerance, and effectiveness of the perindopril/amlodipine FDC in Greek patients with hypertension and stable coronary artery disease (CAD) over a 4-month period. A total of 1907 patients with hypertension and CAD (59.1% males) who had recently (≤2weeks) commenced treatment with the perindopril/amlodipine FDC (5/5, 5/10, 10/5, or 10/10mg) were studied at baseline and at 1 and 4months. Adherence to treatment was assessed with the Morisky Medication-taking Adherence Scale (MMAS). Seven patients (0.4%) did not attend the scheduled visits. In total, 1607 (84.6%) patients received a constant treatment dose throughout the study. High adherence (MMAS score=0) was reported by 1592 (83.6%), 1628 (85.7%), and 1477 (77.7%) patients at the second and thethird visit and at both visits, respectively. Adverse reactions were reported by only 13 (0.7%) patients, were all minor, and did not result in treatment discontinuation. Office blood pressure (BP) was significantly decreased at the third visit (130.8±8.4/78.2±6.4mmHg) compared with baseline (156.5±15.0/89.9±9.6mmHg; p<0.001), regardless of previous antihypertensive treatment. Patients with grade 1, 2, and 3 hypertension at baseline showed a reduction in BP of 19.3/9.4, 31.5/13.5, and 47.8/22.2mmHg, respectively (p<0.001). Uncontrolled hypertension (≥140/90mmHg) was notably reduced from 90.3% at baseline to 18.5% at the third visit. The perindopril/amlodipine FDC is characterized by high adherence and effectiveness, regardless of previous treatment. Degree of BP reduction was related to baseline BP levels. Clinical trials registration number (Protocol Number): IC4 - 05985 - 011 - GRC.

Heart Failure Predictors in a Group of Patients with Myocardial Infarction.

AIM:The present study considers of the prevalence of heart failure (HF) in patients suffering from acute myocardial infarction (AMI) in the University Hospital Centre of Tirana (UHCT) “Mother Theresa”; the demographic and clinical characteristics of the sample during hospitalization; and the main predictors of heart failure occurrence inside the group of patients suffering an AMI.MATERIAL AND METHODS:During a period of study from 2013-2015 we studied demographic and clinical data from 587 consecutive patients presenting with AMI; Framingham criteria were adopted for classifying patients with HF upon admission.RESULTS:A Killip class ≥ 2 was the main diagnostic criterion of HF during hospitalisation. HF was identified in 156 patients (26.6%). The subgroup with HF had significant differences when compared with the other patients with regard to age, sex (male), heart rate upon admission, systolic blood pressure on admission, previous episodes of AMI, glycemia on admission, previous antihypertensive treatment, previous revascularization procedures, peripheral vascular disease, chronic renal disease, ejection fraction (EF), anemia, and atrial fibrillation presence. Independent predictors for HF occurrence in the logistic regression model were EF, previous revascularization, peripheral vascular disease, age, sex, previous AMI, systolic blood pressure upon admission, and anaemia.CONCLUSION:As a conclusion, HF seems to be a common occurrence after AMI, in spite of changes in the epidemiological profile of the acute coronary syndrome. An increase in the incidence is registered as well, parallel to a decrease in the mortality following AMI. Attention must be shown for highly risked subpopulations, aged persons, patients with the previous coronary disease, and concomitant conditions.

Combination therapy with nifedipine GITS 60 mg: subanalysis of a prospective, 12-week observational study (AdADOSE)

Background: AdADOSE was a 12-week, international, observational study conducted in the Middle East and Russia where patients received nifedipine gastrointestinal therapeutic system (GITS) at a daily dose of 30, 60, or 90 mg as part of an antihypertensive combination therapy. This subgroup analysis of the AdADOSE study assesses the efficacy and tolerability of nifedipine GITS combination therapy when used specifically at the 60-mg strength. Methods: Patients with hypertension who received a daily nifedipine GITS dose of 60 mg, either at constant dose (n = 686) or up-titrated from 30 mg (n = 392), were analyzed. Target blood pressure (BP) was <140/90 mmHg (or <130/80 mmHg for those at high/very high cardiovascular risk). Results: Following nifedipine GITS combination therapy, target BP was achieved by 33.7% patients in the 60 mg group (previously untreated, 42.5%; previously treated, 32.0%) and 32.4% patients in the 30–60 mg group (previously untreated, 45.2%; previously treated, 30.7%). Mean systolic BP/diastolic BP changes were −40.3/−20.7 mmHg and −35.6/−18.5 mmHg, respectively, and were similar regardless of previous antihypertensive treatment or the number of concomitant diseases. Incidences of drug-related adverse events (AEs) were low (3.2%, 60 mg; 2.0%, 30–60 mg group), few patients discontinued because of AEs (0.6% and 1.0%, respectively), and there were no serious AEs. Conclusion: Combination therapy with nifedipine GITS 60 mg in a real-life observational setting was effective and well tolerated in hypertensive patients, with low rates of treatment-related AEs.Trial registration: ClinicalTrials.gov identifier: NCT01118286.

Differences between clinic blood pressure and morning home blood pressure, as shown by Bland-Altman plots, in a large observational study (HONEST study).

When interpreting home blood pressure (BP) measurements in hypertensive patients, differences between clinic and home BP should be noted. To investigate the differences between clinic and morning home BP in hypertensive patients, we analyzed clinic systolic BP (CSBP) and morning home systolic BP (MHSBP) data from the large-scale observational HONEST (Home BP measurement with Olmesartan Naive patients to Establish Standard Target blood pressure) study (n=21 340), using BP measurements obtained before starting olmesartan administration. We generated Bland–Altman plots, with the horizontal axis representing mean CSBP and MHSBP ([CSBP+MHSBP]/2) and the vertical axis representing the difference between CSBP and MHSBP (CSBP–MHSBP). We also did simulation experiments to explore factors affecting the results of the Bland–Altman plots. The difference between CSBP and MHSBP increased as the mean of the two values increased, and when the mean of CSBP and MHSBP was close to 140 mm Hg, the difference was theoretically 0 in average, although large interindividual BP variability existed in this BP range. Results were unaffected by factors such as previous antihypertensive treatment, age and concomitant diabetes or chronic kidney disease. Bland–Altman plots generated from simulated data of normal distribution showed that the slope of the regression line sloped upward, consistent with the results of the HONEST study, when the interindividual BP variability of MHSBP was less than that of CSBP. In conclusion, differences between mean CSBP and MHSBP may be caused by large interindividual variability in CSBP. Therefore, the differences between MHSBP and CSBP may vary between patient groups, which should be noted in the management of hypertension.

The first results of an international clinical trial VICTORY:the efficacy and safety of antihypertensive valsartan monotherapy and the fixed combination of valsartan and hydrochlorothiazide usingdifferent dosage regimens in patients with 1-2 degree arterial hypertension

On behalf of the group of russian researchers. The aim of the VICTORY study was to estimate the efficacy and safety of valsartan monotherapy using different dose regimes (Valsacor® 80, 160, 320 mg) and its fixed combination with hydrochlorothiazide (HCTZ) using different dosage regimens [Valsacor® H160 (valsartan 160 mg + HCTZ12.5 mg), Valsacor® H320 (valsartan 320 mg + HCTZ 12.5 mg) Valsacor® HD320 (valsartan 320 mg + HCTZ 25 mg)] in reaching the target level of blood pressure (BP) in patients with 1-2 degree arterial hypertension (AH).Materials and methods. There are 130 patients with 1-2 degree AH were enrolled in the open international multicenter prospective randomized study from 7 cities in 8 Russian Clinical Centers in Russia. The starting dose of valsartan depended upon the previous antihypertensive treatment: for previously untreated patients - 80 mg (Valsacor® 80 mg, KRKA, Slovenia) with randomization into 4 parallel groups (n=108) for the patients receiving antihypertensive therapy during the screening, after washout 7-day period of Valsacor® 160 mg application with randomization into 8 parallel groups (n=22). Besides the dynamics of clinical BP, we evaluated the impact of therapy on pulse ware velocity, erectile function (in men) and the quality of life. Results. The clinical BP in 130 patients with AH with age of 55.6±11.5 years (65% women) at the moment of inclusion into the study was 157.6/95.1 mm Hg. The BP was reduced to 140.9/85.3 mm Hg on the 4-week of valsartan 80 or 160 mg application. Valsartan titration or the combination of valsartan and HCTZ on the 8-week helped to reduce BP to 135.2/83.5 mm Hg. The 16-week treatment showed the BP reduced to 129.2/79.4 mm Hg. ( p

Первые результаты международного клинического исследования VICTORY: эффективность и безопасность антигипертензивной монотерапии валсартаном и его фиксированной комбинации с гидрохлоротиазидом в разных дозовых режимах у пациентов с артериальной гипертонией 1–2-й степени

On behalf of the group of russian researchers. The aim of the VICTORY study was to estimate the efficacy and safety of valsartan monotherapy using different dose regimes (Valsacor® 80, 160, 320 mg) and its fixed combination with hydrochlorothiazide (HCTZ) using different dosage regimens [Valsacor® H160 (valsartan 160 mg + HCTZ12.5 mg), Valsacor® H320 (valsartan 320 mg + HCTZ 12.5 mg) Valsacor® HD320 (valsartan 320 mg + HCTZ 25 mg)] in reaching the target level of blood pressure (BP) in patients with 1-2 degree arterial hypertension (AH).Materials and methods. There are 130 patients with 1-2 degree AH were enrolled in the open international multicenter prospective randomized study from 7 cities in 8 Russian Clinical Centers in Russia. The starting dose of valsartan depended upon the previous antihypertensive treatment: for previously untreated patients - 80 mg (Valsacor® 80 mg, KRKA, Slovenia) with randomization into 4 parallel groups (n=108) for the patients receiving antihypertensive therapy during the screening, after washout 7-day period of Valsacor® 160 mg application with randomization into 8 parallel groups (n=22). Besides the dynamics of clinical BP, we evaluated the impact of therapy on pulse ware velocity, erectile function (in men) and the quality of life. Results. The clinical BP in 130 patients with AH with age of 55.6±11.5 years (65% women) at the moment of inclusion into the study was 157.6/95.1 mm Hg. The BP was reduced to 140.9/85.3 mm Hg on the 4-week of valsartan 80 or 160 mg application. Valsartan titration or the combination of valsartan and HCTZ on the 8-week helped to reduce BP to 135.2/83.5 mm Hg. The 16-week treatment showed the BP reduced to 129.2/79.4 mm Hg. ( p <0.000001). The therapy was statistically significant reducing the level of heart rate and did not affect aortic augmentation index and the condition of erectile function. The percentage of patients who had the departure from normal blood glucose levels, creatinine and potassium, did not increase since the beginning of the study till the 16-week of treatment. Adverse effects were observed in 9.2% of patients, the connection with the drugs was assessed as improbable and in one case as possible, the severity - was moderate or slight.Conclusions:Valsartan monotherapy and the combination of valsartan and HCTZ significantly reduce the systolic BP and diastolic BP to normal levels in patients with 1-2 degree arterial hypertension.As a result of valsartan therapy and the combination with HCTZ the target BP values were achieved at 91% of all patients involved in the study.Valsartan monotherapy and the combination of valsartan and HCTZ led to heart rate reduction and did not affect aortic augmentation index.Therapeutic effect was very good in 89.1% of the patients and good - in 7.0%.The overall clinical efficiency was measured as extremely high in 73.4% of patients, very high - in 15.6% and high - in 6.3%.On assessing the impact of the therapy on the quality of life of patients we noted that 78.7% of patients were in good health, and in 18.1% of cases the treatment did not worsen the general well-being of the patient.

Abstract 636: Factors Impacting Blood Pressure Control in the Elderly and very Elderly Hypertensive Patients After 8 Weeks Valsartan/Amlodipine SPC Treatment: CHINA STATUS II Subgroup Analysis

Objective: To determine the factors that impact BP control in Chinese elderly (aged 65-79 years) and very elderly (aged ≥80 years) hypertensive patients after 8-week treatment with val/aml SPC in the CSII study. Design and Methods: 3609 elderly and very elderly hypertensive patients uncontrolled by monotherapy with BP ≥140/90 mm Hg (≥130/80 mm Hg for diabetes or CKD) were analyzed. It was a post-hoc analysis of subgroups from the CSII study. All patients received val/aml 80/5 mg SPC for 8 weeks. An additional antihypertensive agent added in patients who were still uncontrolled at the end of 4 weeks. Complications, previous antihypertensive treatment and demographic factors were recorded. Chi-square test, Student’s t-test and logistic regression analysis were conducted. Results: After 8 weeks treatment, 61.5% elderly (n=459) and 63.3% very elderly (n=1811) patients achieved BP control. In the 740 elderly patients, low BP control rates were observed in patients with coronary heart disease (CHD) [P &lt;0.05 vs without CHD]. Significant decrease of BP control rates also were observed in 620 elderly type 2 diabetes mellitus (DM) patients (P&lt;0.0001 vs. non-diabetics) and 89 elderly heart failure (HF) patients (P&lt;0.05, vs without HF) while stroke had no effect(P&gt;0.05). Previous antihypertensive treatment (ACEI, ARB, CCB, βblocker and diuretic) had no significant influence on BP control (P&gt;0.05 ) . Among cardiovascular risk factors , while dyslipidemia influenced the BP control rate(P&lt;0.05); patient’s sex, BMI, smoking and alcohol consumption had no effect(P&gt;0.05). In very elderly patients, DM led to low BP control (P&lt;0.0001), but there was no significant impact of CHD, HF and stroke. Previous antihypertensive drugs did not influence the BP control rate (P&gt;0.05), but alcohol consumption had a significant impact (P&lt;0.05). Conclusion: CHD, DM, HF and dyslipidemia negatively influenced BP control in the elderly patients. In the very elderly patients, diabetes and history of alcohol consumption were associated with low BP control rates. The effect of the above risk factors on BP control should be considered during the management of hypertension in the elderly and very elderly Chinese patients with above complications as they would need stricter BP control.

Olmesartan vs. Ramipril in Elderly Hypertensive Patients: Review of Data from Two Published Randomized, Double-Blind Studies

Hypertension is a frequent condition among individuals over 65years of age worldwide and is one of the most important risk factors for cardiovascular (CV) disease. Effective drug treatment of elderly hypertensives is usually associated with a marked reduction in CV morbidity and mortality. Among the different classes of antihypertensive agents, angiotensin receptor blockers (ARBs) and ACE-inhibitors are supposed to provide the best efficacy in lowering blood pressure (BP) and protecting target organ damage while featuring a good tolerability profile. However, up to date, few randomized clinical studies have directly compared the activity and safety of ARBs and ACE-inhibitors in elderly hypertensive patients. Aim of this review of published and unpublished pooled data from two recent randomized, double-blind, controlled trials, is to offer a comprehensive head-to-head comparison of the antihypertensive efficacy of the ARB olmesartan medoxomil vs. the ACE-inhibitor ramipril in a large study population including more than 1,400 hypertensive subjects aged 65-89years with mild-to-moderate essential hypertension. The efficacy of the two drugs was separately evaluated in subgroups of patients classified according to the presence of metabolic syndrome, reduced renal function, CV risk level, gender, class of age, type of arterial hypertension and previous antihypertensive treatments. Olmesartan showed a greater efficacy than ramipril both in terms of clinic BP reduction and rate normalization. Olmesartan appeared significantly superior to ramipril in providing a more homogeneous and long-lasting 24-h BP control and maintaining an effective antihypertensive action in the last 6-h period from drug intake. In subgroups of patients with additional clinical conditions, olmesartan gave comparable, and in some cases greater, BP responses than those achieved with the ACE-inhibitor. The incidence of adverse events was similar for both drugs. Olmesartan may thus represent an effective alternative to ACE-inhibitors among first-line drug treatments for hypertension in older people.