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04:46 EDT 18th April 2015 | BioPortfolio

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Showing "Anthera halts VISTA heart drug trial" PubMed Articles 1–25 of 17,000+

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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).

42 Meta-Analysis Identifying the Source of Conflict Between Different Trial Reports on the Effect of CRT in Heart Failure with Narrow QRS Complexes.

Biventricular pacing (CRT) shows clear benefits in heart failure with wide QRS, but results in patients with narrow QRS have been conflicting. In this meta-analysis we tested the hypothesis that trial design might have influenced findings.

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.

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 ...

Statistical consideration and challenges in bridging study of personalized medicine.

Abstract Applications of personalized medicine are becoming increasingly prominent. A well-characterized market-ready companion diagnostic assay (CDx) is often desired for patient enrollment in device-drug pivotal clinical trial(s) so that Food and Drug Administration can ensure that appropriate clinical and analytical validation studies are planned and carried out for CDx. However, such a requirement may be difficult or impractical to accomplish. A clinical trial assay (CTA) instead of CDx may be used for ...

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 Trial Comparing Robotic to Manual Ablation for Atrial Fibrillation.

Catheter ablation of atrial fibrillation (AF) is a physically demanding procedure for the operator, involving radiation exposure, and has limited success rates. Remote robotic navigation (RRN) may offer benefit to the procedure, though only one previous small randomized trial has assessed this.

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 ...

Drug Development for Pediatric Neurogenic Bladder Dysfunction: Dosing, Endpoints, and Study Design.

Pediatric drug development is challenging when a product is studied for a pediatric disease that has a different underlying etiology and pathophysiology compared to the adult disease. Neurogenic bladder dysfunction (NBD) is such a therapeutic area with multiple unsuccessful development programs. The objective of this study was to critically evaluate clinical trial design elements that may have contributed to unsuccessful drug development programs for pediatric NBD. Trial design elements of drugs tested for ...

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...

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...

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...


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