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These data demonstrate that SIL does not potentiate NEB-induced vasodilation in vitro. These findings indicate that the interaction between SIL and NO-donators/organic nitrates does not apply to the NO-liberating properties of NEB. Our findings suggest that SIL may safely be used in hypertensive patients treated with NEB.
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Ranitidine had no significant effect on nebivolol pharmacokinetics. Cimetidine, however, resulted in a 21-23% increase in Cmax of unchanged nebivolol and of each enantiomer plus its hydroxylated metabolites. Cimetidine significantly (p < 0.05) increased the AUC [mean +/- s.d. (95% C.I. of differences in mean)] for unchanged (+/-)-nebivolol [7.76 +/- 3.07 ng ml-1 h with placebo; 11.50 +/- 5.40 (1.75, 8.76) ng ml-1 h with cimetidine], (+)-nebivolol plus its hydroxylated metabolites [73.0 +/- 18.0 ng ml-1 h with placebo; 91.5 +/- 25.7 (1.0, 23.1) ng ml-1 h with cimetidine] and (-)-nebivolol plus its hydroxylated metabolites [101 +/- 32 ng ml-1 h with placebo; 123 +/- 38 (3.3, 27.0) ng ml-1 h with cimetidine]. Statistical analysis of the resting blood pressure and heart rate and exercise data did not suggest any consistent effects of ranitidine or cimetidine upon the pharmacodynamic effects of nebivolol.
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Repeated cross-sectional analysis of a nationally representative primary care database (DIN-LINK).
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The year 2004 was not marked by major pharmacological advances, but by confirmation of previous "evidence". Several innovative drugs for stable angina (ranolazine, ivabradine), some interesting results in acute coronary syndrome (PROVE IT study), some classic concepts (cannabinoid receptors and their antagonists such as rimonabant) applied to novel indications (treatment of obesity), hopes for the "sartans" revived in the light of new evidence (VALUE study), advances in the management of diabetes and hypertension (ASCOT and CARDS studies), nebivolol which is not just a betablocker but also produces the NO radical (is this why it decreased the mortality of heart failure in the elderly in the SENIOR study?). In contrast, although Chronadalate did not live up to expectations for coronary insufficiency, the year was marked above all by the much heralded withdrawal of Vioxx for increasing cardiovascular risk. The old adage: primum non nocere springs to mind.
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The aim of this study was to examine the effectiveness of Ivabradine (available under the brandnames of Procoralan, Coralan, Corlentor, Coraxan, "Servier", France) and Nebivolol (Nebilet, "Berlin-Chemie", Germany) with combination of standard therapy in patients with coronary artery disease and left ventricular dysfunction. A total of 72 patients (mean age 57.3±4,5 years) have been observed during 6 months. Patients were divided into 3 groups (standard therapy; standard therapy and Nebilet; standard therapy and Coraxan). The results showed that Coraxan with combination therapy compared optimally reduced heart rate and ensure a proper anti-ischemic effect, expressed as reduced left ventricular dysfunction, improved the degree of congestive heart failure than the group Nebilet.
We studied whether the β1-adrenergic antagonist nebivolol would prevent ethanol-induced reactive oxygen species generation and lipoperoxidation in the rat renal cortex. Male Wistar rats were treated with ethanol (20% v/v) for 2 weeks. Nebivolol (10mg/kg/day; p.o. gavage) prevented both the increase in superoxide anion (O2(-)) generation and thiobarbituric acid reactive substances (TBARS) concentration induced by ethanol in the renal cortex. Ethanol decreased nitrate/nitrite (NOx) concentration in the renal cortex, and nebivolol prevented this response. Nebivolol did not affect the reduction of hydrogen peroxide (H2O2) concentration induced by ethanol. Nebivolol prevented the ethanol-induced increase of catalase (CAT) activity. Both SOD activity and the levels of reduced glutathione (GSH) were not affected by treatment with nebivolol or ethanol. Neither ethanol nor nebivolol affected the expression of Nox1, Nox4, eNOS, nNOS, CAT, Nox organizer 1 (Noxo1), c-Src, p47(phox) or superoxide dismutase (SOD) isoforms in the renal cortex. On the other hand, treatment with ethanol increased Nox2 expression, and nebivolol prevented this response. Finally, nebivolol reduced the expression of protein kinase (PK) Cδ and Rac1. The major finding of our study is that nebivolol prevented ethanol-induced reactive oxygen species generation and lipoperoxidation in the kidney by a mechanism that involves reduction on the expression of Nox2, a catalytic subunit of NADPH oxidase. Additionally, we demonstrated that nebivolol reduces NADPH oxidase-derived reactive oxygen species by decreasing the expression of PKCδ and Rac1, which are important activators of NADPH oxidase.
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The Effect of Long-term Administration of Nebivolol on clinical symptoms, exercise capacity and left ventricular function in patients with Diastolic Dysfunction (ELANDD) study is a prospective multicenter European trial in 120 patients with HFPEF randomised to nebivolol or placebo. HFPEF is defined as symptoms or signs of heart failure, a LV ejection fraction >45% and evidence of diastolic LV dysfunction by Doppler echocardiography. Procedures include a baseline clinical examination, 6-min walk test (6MWT), electrocardiography, Doppler echocardiography and Minnesota QoL questionnaire. Nebivolol or placebo is started at 2.5 mg/day and gradually uptitrated to 10 mg/day. After initiation of the study, patients are assessed at 1, 2, 5 and 6 weeks (titration phase) and at weeks 12 and 26. The primary endpoint is the change from baseline in the 6MWT distance with nebivolol versus placebo. Sample size calculations are based on an anticipated 15% difference (70 m) in the 6MWT distance between nebivolol and placebo-treated patients. This study will allow the collection of data regarding the possible clinical benefits and the effects on LV function of nebivolol administration in patients with HFPEF.
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A randomized, double-blind crossover trial, consisting of two 12-week treatment phases separated by a 4-week wash-out phase.
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We conclude that 24-hour ambulatory hemodynamic monitoring is feasible in clinical trials. The rate-slowing effects of nebivolol (both N and V/N) cause lower ambulatory cardiac oxygen consumption compared to V alone but at the same time, N and V/N cause an increase in stroke load. Absolute and relative heart rate variability is higher with V than N or V/N. These results are driven primarily by the effects in blacks.(Figure is included in full-text article.).
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Echocardiography, doppler echocardiography and venous occlusion plethysmography were used for the study of effects of monotherapy with nebivolol (2.5-10, mean 5.1 mg/day for 24 weeks) on remodeling of cardiovascular system and the state of hemodynamics in 25 patients with stage II hypertension and chronic heart failure (NYHA class I-II). Treatment with nebivolol was associated with lowering of systolic and diastolic blood pressure (by 22% and 26%, respectively), significant reduction of left ventricular mass index, improvement of parameters of systolic and diastolic left ventricular function and lowering of NYHA class of heart failure. Favorable changes of remodeling of peripheral vessels and of endothelium-dependent vasodilatation also occurred.
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The CYP2D6*10 genotype and phenotype were not associated with significant alterations in the pharmacokinetics of nebivolol. CYP2D6*10 alone does not account for the large interindividual differences observed in the disposition of nebivolol among Chinese healthy subjects.
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This article provides information and a commentary on landmark trials presented at the European Society of Cardiology Congress in August 2004, relevant to the pathophysiology, prevention or treatment of heart failure. The SENIORS trial suggests that nebivolol is well tolerated and effective in older patients with heart failure, even if left ventricular systolic function is not markedly depressed. However, patients aged >75 years appeared to gain less benefit. Further data on the effects of nebivolol on symptoms and quality of life are awaited. Two new trials of long-term antibiotic prophylaxis after myocardial infarction (ACES and PROVE-IT) showed no benefit. The ACTION trial showed no reduction in serious cardiovascular events with nifedipine GITS in patients with chronic stable angina, despite a substantial reduction in blood pressure. The HF-ACTION trial announced that the first 700 patients of a projected 3000 had been randomised to either an exercise program or encouragement to exercise but without a formal program. The primary outcome measure is death or hospitalisation for any reason.
Nebivolol is a selective beta 1-adrenergic receptor blocker possessing an ancillary vasodilating effect. The objective of the present study was to study the haemodynamic and pharmacokinetic properties of nebivolol 5 mg once daily in a double-blind, placebo-controlled cross-over study.
The evaluation was based on a postmarketing surveillance study in Germany involving 8682 moderately hypertensive patients. Using the Framingham Risk Model, the antihypertensive effectiveness of nebivolol after 6 weeks of treatment was extrapolated to estimate the reductions in 10-year risks of cardiovascular events. Data sources included direct costs for medical and invasive cardiovascular interventions in Germany, costs of therapy in the US and the UK, and estimates on the prevalence of cardiovascular events issued by the American Heart Association.
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The study included 23 healthy subjects and was designed as an open-label, single-centre, non-randomized, two-period clinical trial. During period 1 (reference), each volunteer received a single dose of 5 mg nebivolol, whereas during period 2 (test), each volunteer received a single dose of 5 mg nebivolol and 20 mg paroxetine, after a pretreatment regimen with paroxetine (20-40 mg/day for 6 days). The pharmacokinetic parameters of nebivolol and its active metabolite were analysed by non-compartmental modelling. The pharmacodynamic parameters (blood pressure and heart rate) were assessed at rest, after each nebivolol intake.
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Beta-blockers have long being used as first-line therapy for hypertension as their use had resulted in a reduction in cardiovascular morbidity and mortality in controlled clinical trials. A recent meta-analysis comparing beta-blockers to all other anti-hypertensive drugs taken together has found that stroke reduction was sub-optimal. Specifically, atenolol was associated with a 26% higher risk of stroke compared with other drugs. Several reasons may explain the less favourable outcomes with beta-blocker therapy. These include some adverse metabolic abnormalities such as dyslipidaemia and new-onset diabetes, and less effective reduction of central aortic compared with brachial blood pressure. Newer beta-blockers such as carvedilol or nebivolol are better tolerated. These beta-blockers have a vasodilating effect, which may beneficially affect systolic blood pressure in the aorta. Their long-term cardiovascular outcome in hypertension is still not known. Further studies would be required to show that stroke is adequately reduced by these newer beta-blockers. In conclusion, beta-blockers should not be the first drugs of choice in the management of uncomplicated hypertension. They may be used in addition to other antihypertensive agents to achieve blood pressure goals. However, in patients with angina pectoris, a previous myocardial infarction, heart failure and certain dysrhythmias, beta-blockers still play an important role.
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The new Czech and European recommendations for diagnosis and treatment of heart failure were published in 2012. The American guidelines ACCF/AHA were published in 2013. Main difference between them is presentation of acute and chronic heart failure in the European guidelines while the American and the Czech guidelines include only chronic heart failure. The American recommendations distinguish heart failure with reduced ejection fraction and with remained ejection fraction. In the beginning, the American guidelines introduce A-D classification which doesn´t figure in the European neither Czech guidelines. Class A patients are ill with risk factors, but without heart failure. In contrast, class D patients are decompensated with symptoms in the rest. Epidemiologic data shows interesting results with prevalence about 0.2% in 60-69 years old subjects and 80% in subjects older than 85 years. 5 year mortality is 50%. The American guidelines start to treat class A which is in fact prevention and treatment of risk factors. There is mentioned inevitably treatment of hypertension, both systolic and diastolic which decrease risk of heart failure up to 50%. There is almost no difference in pharmacotherapy. Noteworthy, the American guidelines introduce also ACE inhibitors - fosinopril and quinapril, on the other hand beta-blockers don´t involve nebivolol. Wide range of diuretics are mentioned, some of them aren´t registered in the Czech Republic. European and Czech guidelines involve ivabradin. Neither nesiritid nor levosimendan for inpatients aren´t involved. There is briefly mentioned surgery and cardiac mechanical support, moreover there are references for guidelines for heart transplantation.
Mouse thoracic aorta segments were bathed in an organ chamber. Administration of nebivolol did not affect NO production. When nebivolol was allowed to metabolize in vivo in mice, addition of plasma of these mice caused a sustained 2-fold increase in NO release. Interestingly, coadministration of a selective beta(2)-adrenergic receptor antagonist (butoxamine) prevented the response. Immunohistochemistry and Western blot analysis demonstrated the presence of beta(2)- but not beta(1)-adrenergic receptors on endothelial cells. In the absence of calcium, metabolized nebivolol failed to increase NO production, suggesting a role for calcium-dependent NO synthase. With digital fluorescence imaging, a rapid and sustained rise in endothelial cytosolic free Ca(2+) concentration was observed after administration of metabolized nebivolol, which also was abrogated by butoxamine pretreatment.
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Bisoprolol, carvedilol, metoprolol, and nebivolol are beta-blocker drugs used to improve survival in patients with systolic heart failure. This article reviews these drugs and how practitioners can initiate and titrate them for maximum patient benefit.
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Nitric oxide (NO) deficiency contributes to chronic kidney disease (CKD) progression and hypertension. The β-blocker, nebivolol (N), also enhances NO production, and we studied whether N attenuates CKD and hypertension caused by chronic NO synthase inhibition (CNOSI).
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Starting from 2nd week visit of fixed combination of nebivolol and amlodipine treated patients had significantly lower levels of systolic and diastolic AP. Already after 2 weeks of combined two-component therapy 60% of group 1 and 52% of group 2 patients achieved target AP. Target AP was achieved by the end of month 1 by 86 and 71%, of month 2 - by 93 and 78% of patients in groups 1 and 2, respectively. In 3 months almost all patients had target AP, but in 1.6% of group 1 and 2.3% of group 2 patients this level was achieved after addition of a thiazide diuretic. Patients receiving of fixed combination of nebivolol and amlodipine achieved noromosyslolia more quickly compared with patients who received free combination of nebivolol and amlodipine.
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Nitric oxide (NO) exerts a plethora of vascular beneficial effects. The NO-releasing beta-blocker nebivolol is a racemic mixture of D/L-enantiomers that displays negative inotropic as well as direct vasodilating activity. The in vivo antiatherogenic activity of therapeutic doses of the beta-blocker with antioxidant properties carvedilol (12.5mg/day) or nebivolol (5mg/day) was tested in cholesterol-fed rabbits. Animals received a 1% cholesterol-rich diet alone (controls) or mixed with drugs (treated animals) for 8 weeks. While it did not affect hyperlipidemia, nebivolol inhibited the development of atherosclerosis, expressed as computer-assisted imaging analysis of aortic area covered by lesions (23.3+/-4.1% in treated vs 38.2+/-6.4% in control animals, p<0.01). Differently, in our experimental condition of therapeutic drug doses, this antiatherogenic effect did not reach statistical significance in rabbits treated with carvedilol (32.5+/-5.1% aortic area covered by lesions, p=NS vs controls). Plasma nitrates increased in rabbits treated with nebivolol while both beta-blockers reduced LDL oxidation. Moreover, nebivolol induced a consistent increase of endothelial reactivity and aortic eNOS expression compared with control animals (p<0.05) and those receiving carvedilol (p<0.05). Since NO may exert beneficial effects in atherosclerosis, a NO-dependent mechanism could explain this data. These observations suggest that the NO-releasing beta-blocker, nebivolol, might represent an effective pharmacological approach for preventing atherosclerotic lesion progression.
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The majority of evidence suggesting that beta-blockade should not be used in uncomplicated hypertension comes from studies using atenolol. It would therefore be premature and unwise to eliminate all beta-blockers from the array of agents available to optimize BP control in patients with uncomplicated hypertension by extrapolating data based almost entirely on the conventional beta-blocker atenolol. Vasodilating beta-blockers have beneficial effects on central BP, arterial stiffening, and nitric oxide-dependent endothelial dysfunction that may contribute to their clinical benefits in patients with hypertension.
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It is unclear whether carvedilol and nebivolol produce different effects on short-term left ventricle (LV) systolic function in heart failure (HF). These drugs could improve systolic and diastolic functions of the LV. Thus, we aimed to compare their effects on LV systolic functions in patients with non-ischemic HF.
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Nebivolol, a third-generation beta-blocker (BB) shows a highly selective beta-blockade and specific vasodilating effects due to getting free nitro-oxide from the dysfunctional endothelium.
Heart failure (HF) is a major public health problem among the elderly. The syndrome of HF may arise in the presence of either a depressed or apparently normal left-ventricular ejection fraction (LVEF). The latter entity is more common in the elderly. In elderly patients with HF, prescription of a beta-adrenoceptor antagonist may raise concerns regarding efficacy and tolerability. Because of these concerns, but also as a result of a paucity of published data, beta-adrenoceptor antagonists are under-prescribed to elderly patients with HF in general practice. We review the evidence regarding the efficacy and tolerability of beta-adrenoceptor antagonist therapy in elderly patients with HF. We found three major sources of evidence: one prospective, randomised controlled trial (RCT), SENIORS (Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure); a subgroup meta-analysis of elderly patients included in systolic HF trials; and a large number of observational studies. SENIORS showed that the third-generation beta-adrenoceptor antagonist nebivolol reduces the risk of all-cause mortality or cardiovascular admission in elderly patients (aged > or =70 years) with HF and a broad range of LVEF. The subgroup meta-analysis of RCTs showed that beta-adrenoceptor antagonists reduce mortality in elderly patients (aged 60-80 years) with systolic HF, and that the benefit is similar to that observed in non-elderly patients (aged <60 years). The observational studies showed a beneficial effect of beta-adrenoceptor antagonists in elderly populations in daily practice, including those with depressed and preserved LVEF. However, the effect of beta-adrenoceptor antagonists on all-cause mortality may be lower in very elderly patients (aged >75 years). Approximately two-thirds of elderly patients with HF tolerate a beta-adrenoceptor antagonist, but only 40-70% of the target doses recommended in RCTs are achieved. Some clinical variables may predict low beta-adrenoceptor antagonist tolerability, such as low systolic blood pressure, higher New York Heart Association HF severity class, advanced age and ischaemic cause of HF. Furthermore, prescription of a high diuretic dose and calcium channel antagonists may also decrease beta-adrenoceptor antagonist tolerability. However, it is difficult to identify on clinical grounds patients intolerant to any beta-adrenoceptor antagonist dose. Low-dose therapy (<50% target dose) may be effective in an elderly population with HF, but prescription of at least a medium dose (> or =50% target dose) may achieve a higher benefit. In conclusion, although elderly patients with HF take lower doses of beta-adrenoceptor antagonists, these agents are still effective and overall well tolerated in this population. Elderly patients with HF should therefore not be denied beta-adrenoceptor antagonist therapy. The dilemma relies on dose-benefit balance, as higher doses would be more effective but may raise tolerability concerns. The beneficial effects of use of beta-adrenoceptor antagonists in elderly patients with HF and preserved LVEF need to be further confirmed in large RCTs.
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Nebivolol is a new selective beta 1-adrenergic blocking agent, that possesses a peculiar pharmacodynamic profile and an original chemical structure, by which it differs from traditional beta 1-blockers. Nebivolol is a racemic mixture of two enantiomers in equal ratios. It is endowed with a highly selective beta 1-blocking activity, and does not show an intrinsic sympathomimetic activity. Nebivolol is endowed with peripheral vasodilating properties mediated by the modulation of the endogenous production of nitric oxide. It does not significantly decrease airway conductance compared with atenolol and propranolol. Nebivolol does not compromise the left ventricular function, but it may increase stroke volume, and does not reduce heart inotropism during exertion. Nebivolol is quite safe and is well tolerated, also when compared to traditional beta-blockers. The most common adverse effects are dizziness, headache and fatigue. Owing to its combined dual mechanism of action, nebivolol leads to a unique haemodynamic and therapeutic profile by which it may be advantageous in essential hypertension, ischaemic heart disease and congestive heart failure.
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A total of 40 patients with mild-to-moderate hypertension were randomized to receive either nebivolol (2.5 to 5.0 mg/day) or telmisartan (40 to 80 mg/day) to achieve a target diastolic blood pressure of <90 mm Hg. Blood pressure (BP) was measured with sphygmomanometry, and LVM and midwall fractional shortening (mFS) were estimated by two-dimensionally guided M-mode echocardiography at baseline and at 3-month follow-up.