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Showing "Anthera halts VISTA heart drug trial" PubMed Articles 1–25 of 16,000+

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Potential Applications of Pharmacogenomics to Heart Failure Therapies.

Pharmacogenomics explores one drug's varying effects on different patient genotypes. A better understanding of genomic variation's contribution to drug response can impact 4 arenas in heart failure (HF): (1) identification of patients most likely to receive benefit from therapy, (2) risk stratify patients for risk of adverse events, (3) optimize dosing of drugs, and (4) steer future clinical trial design and drug development. In this review, the authors explore the potential applications of pharmacogenomics...

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Drug therapy for patients with systolic heart failure after the PARADIGM-HF trial: in need of a new paradigm of LCZ696 implementation in clinical practice.

Heart failure represents a primary cause of morbidity and mortality in older people and despite significant therapeutic advances, it is still characterized by important unmet needs, thus remaining a challenging field of clinical research. The recent PARADIGM-HF trial compared the novel compound LCZ696, a combination of the angiotensin receptor blocker valsartan and the neprilysin inhibitor sacubitril, versus the angiotensin-converting enzyme inhibitor enalapril in 8,442 patients with symptomatic chronic sys...

The Effect of Coenzyme Q10 on Morbidity and Mortality in Chronic Heart Failure: Results From Q-SYMBIO: A Randomized Double-Blind Trial.

This randomized controlled multicenter trial evaluated coenzyme Q10 (CoQ10) as adjunctive treatment in chronic heart failure (HF).

Nurse-Led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials, and Outcomes Used in the Clinical Trial.

The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure (HF) patients.

Clinical characteristics and outcomes of patients with and without diabetes in the Surgical Treatment for Ischemic Heart Failure (STICH) trial.

Hypothesis 1 of the Surgical Treatment for Ischemic Heart Failure (STICH) trial enrolled 1212 patients with an LVEF of ≤35% and CAD amenable to coronary artery bypass grafting (CABG). Patients were randomized to CABG and optimal medical therapy (MED) or MED alone. The objective was to assess whether or not patients with diabetes mellitus (DM) enrolled in the STICH trial would have greater benefit from CABG than patients without DM.

A prospective, double-blind, randomized controlled trial of the angiotensin-converting enzyme inhibitor Ramipril In Aortic Stenosis (RIAS trial).

Angiotensin-converting enzyme (ACE) inhibitors improve left ventricular (LV) remodelling and outcome in heart failure and hypertensive heart disease. They may be similarly beneficial in patients with aortic stenosis (AS), but historical safety concerns have limited their use, and no prospective clinical trials exist.

Current Perspectives on Hydralazine and Nitrate Therapies in Heart Failure.

The origins of the hydralazine/isosorbide dinitrate (H+ISDN) combination therapy are rooted in the first large-scale clinical trial in heart failure: V-HeFT I. Initially utilized for the balanced vasodilatory properties of each drug, we now know there is "more to the story." In fact, the maintenance of the nitroso-redox balance may be the true mechanism of benefit. Since the publication of V-HeFT I 30 years ago, H+ISDN has been the subject of much discussion and debate. Regardless of the many controversies ...

Post-trial induction of conditioned apomorphine stimulant and inhibitory response effects: Evidence for potent trace conditioning of drug effects.

The Pavlovian conditioning of drug effects has frequently been demonstrated using protocols that are variants of Pavlovian delay conditioning. We undertook to determine if drug conditioning could be induced using a Pavlovian trace conditioning procedure. Rats were tested in a novel open-field environment for 5minutes and in post-trial phase were injected either with vehicle, 2.0mg/kg or 0.05mg/kg apomorphine immediately or after a delay of 15minutes. The procedure was repeated three times and subsequently a...

BiDil in the Clinic: An Interdisciplinary Investigation of Physicians' Prescription Patterns of a Race-Based Therapy.

The African American Heart Failure Trial (A-HeFT) and the FDA approval of BiDil for race-specific prescription have stirred the debate about the scientific and medical status of race. Yet there is no assessment of the potential fallouts of this dispute on physicians' willingness to prescribe the drug. We present here an analysis of the factors influencing physicians' prescription of BiDil and investigate whether exposure to the controversy has an impact on their therapeutic judgments about the drug.

Neprilysin Inhibition for Heart Failure.

To the Editor: McMurray et al. (Sept. 11 issue)(1) report on the results of PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial), which showed that the angiotensin receptor-neprilysin inhibitor LCZ696, as compared with angiotensin-converting-enzyme (ACE) inhibitors alone, might improve the prognosis in patients with heart failure and a reduced e...

Neprilysin Inhibition for Heart Failure.

To the Editor: McMurray et al. (Sept. 11 issue)(1) report on the results of PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial), which showed that the angiotensin receptor-neprilysin inhibitor LCZ696, as compared with angiotensin-converting-enzyme (ACE) inhibitors alone, might improve the prognosis in patients with heart failure and a reduced e...

Neprilysin Inhibition for Heart Failure.

To the Editor: McMurray et al. (Sept. 11 issue)(1) report on the results of PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial), which showed that the angiotensin receptor-neprilysin inhibitor LCZ696, as compared with angiotensin-converting-enzyme (ACE) inhibitors alone, might improve the prognosis in patients with heart failure and a reduced e...

Neprilysin Inhibition for Heart Failure.

To the Editor: McMurray et al. (Sept. 11 issue)(1) report on the results of PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure Trial), which showed that the angiotensin receptor-neprilysin inhibitor LCZ696, as compared with angiotensin-converting-enzyme (ACE) inhibitors alone, might improve the prognosis in patients with heart failure and a reduced e...

Randomized comparison of biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for percutaneous coronary revascularization: Rationale and design of the BIOSCIENCE trial.

Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vas...

Concomitant drugs with low risks of drug-drug interactions for use in oncology clinical trials.

Drug-drug interactions (DDIs) may occur with investigational drugs and affect patient safety, trial outcomes, and drug development. A list of preferred drugs with minimal risks of DDIs for treatment of symptoms or comorbidities frequently encountered by cancer patients would be helpful.

New opportunity for orphan drug development in Japan: Early exploratory clinical trial bases promote drug translation from basic studies to clinical application.

In Japan, although orphan drug legislation has been established in 1993 to encourage drug research and development (R&D) for intractable and rare diseases, nearly half of the orphan drugs in the Japanese market originated from the European Union (EU) or the United States of America (USA). Availability of orphan drugs for intractable and rare diseases is compounded by the "drug lag" phenomenon, which is mainly caused by the imperfect clinical trial environment in Japan. In recent years, the Japanese governme...

G-Protein Beta-3 Subunit Genotype Predicts Enhanced Benefit of Fixed-Dose Isosorbide Dinitrate and Hydralazine: Results of A-HeFT (African American Heart Failure Trial).

The purpose of this study was to evaluate the influence of the guanine nucleotide-binding proteins (G-proteins), beta-3 subunit (GNB3) genotype on the effectiveness of a fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) in A-HeFT (African American Heart Failure Trial).

Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial.

New oral anticoagulants for stroke prevention in atrial fibrillation were developed to be given in fixed doses without the need for the routine monitoring that has hindered usage and acceptance of vitamin K antagonists. A concern has emerged, however, that measurement of drug concentration or anticoagulant activity might be needed to prevent excess drug concentrations, which significantly increase bleeding risk. In the ENGAGE AF-TIMI 48 trial, higher-dose and lower-dose edoxaban were compared with warfarin ...

IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (studie IMPROVE-IT).

Background: The IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) is evaluating the potential benefit for reduction in major cardiovascular (CV) events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol (LDL-C) 125 mg/dl.Methods: Randomized double blind clinical trial in patients with acute coronary syndrome and low cholesterol level. The simvastatin...

Lipid-Modifying Treatments for Heart Failure: Is Their Use Justified?

Interventions for coronary artery disease in heart failure have not been successful. It seems unlikely that coronary events play no role in the progression of heart failure and the ultimate demise of the patient. Meta-analysis suggests no benefit of fibrates in cardiovascular disease or heart failure. Polyunsaturated fats have equal benefit in cardiovascular disease. Two large trials of statins found no effect on mortality, but one trial found a reduction in morbidity. Retrospective analyses suggest that pa...

The Anti-Addiction Drug Ibogaine and the Heart: A Delicate Relation.

The plant indole alkaloid ibogaine has shown promising anti-addictive properties in animal studies. Ibogaine is also anti-addictive in humans as the drug alleviates drug craving and impedes relapse of drug use. Although not licensed as therapeutic drug and despite safety concerns, ibogaine is currently used as an anti-addiction medication in alternative medicine in dozens of clinics worldwide. In recent years, alarming reports of life-threatening complications and sudden death cases, temporally associated w...

Sequentially Updating the Likelihood of Success of a Phase 3 Pivotal Time-To-Event Trial based on Interim Analyses or External Information.

Abstract When performing a pivotal clinical trial, it may be of interest to assess the probability of success (PoS) of that trial. Initially evaluated when the trial is designed, PoS can be updated as the trial progresses and new information about the drug effect becomes available. Such information can be external to the trial, such as results from trials conducted in parallel, or internal, such as continuing after an interim analysis. We develop a framework to update PoS based on such internal and external...

Renal denervation therapy for hypertension: pathways for moving development forward.

This scientific statement provides a summary of presentations and discussions at a cardiovascular Think Tank co-sponsored by the American Society of Hypertension (ASH), the United States Food and Drug Administration (FDA), and the National Heart, Lung, and Blood Institute (NHLBI) held in North Bethesda, Maryland, on June 26, 2014. Studies of device therapies for the treatment of hypertension are requested by regulators to evaluate their safety and efficacy during their development programs. Think Tank parti...

Factors predisposing to ventricular proarrhythmia during antiarrhythmic drug therapy for atrial fibrillation in patients with structurally normal heart.

Ventricular arrhythmia (VA) can occur during propafenone therapy in atrial fibrillation (AF) patients with structurally normal heart.

Rethinking Phase II Clinical Trial Design in Heart Failure.

The incidence and economic burden of heart failure continue to rise worldwide, despite implementation of a number of effective heart failure therapies. Although there have been a number phase I-II studies of potential novel heart failure therapies over the past decade, none of these new compounds have been successful in phase III clinical trials. While there are likely a number of reasons for this failure, one of the problems that has become increasingly apparent is the inability of phase II trials to corre...


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