PubMed Journals Articles About "Anthera Halts VISTA Heart Drug Trial" RSS

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

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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...

Drug-drug interaction between clobazam and cannabidiol in children with refractory epilepsy.

Under an expanded access investigational new drug (IND) trial, cannabidiol (CBD) is being studied as a possible adjuvant treatment of refractory epilepsy in children. Of the 25 subjects in the trial, 13 were being treated with clobazam (CLB). Because CLB and CBD are both metabolized in the cytochrome P450 (CYP) pathway, we predicted a drug-drug interaction, which we evaluate in this article.

Relevant

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.

Digoxin Therapy and Associated Clinical Outcomes in the MADIT-CRT Trial.

Digoxin's pharmacological, hemodynamic, and electrophysiological properties are well understood. However, in modern heart failure (HF) treatment, its effect has yet to be fully investigated.

Early vs. late worsening heart failure during acute heart failure hospitalization: insights from the PROTECT trial.

Worsening heart failure (WHF) symptoms despite initial therapy during admission for acute heart failure (AHF) is associated with worse outcomes. The association between the time of the WHF event and the intensity of WHF therapy with outcomes is unknown.

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...

Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human Mitral Valve Repair Clinical Trial (MAVERIC).

The MAVERIC trial (Mitral Valve Repair Clinical Trial) reports the safety and efficacy of the ARTO system in patients with symptomatic heart failure and functional mitral regurgitation (FMR).

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...

US FDA oncology drug approvals in 2014.

ABSTRACT  Cancer is a close second to heart disease for cause of death in the USA, and could soon surpass heart disease as the population ages and the incidence of cancer continues to increase. While heart disease can be addressed through behavior modification and education (e.g., smoking cessation, dietary changes, exercises that promote cardiovascular fitness), pharmacology and improved surgical devices and methods, cancer ultimately requires improved and novel drug treatments to bring mortality rates d...

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...

4A.02: STENTING OF ATHEROSCLEROTIC RENAL ARTERY STENOSIS DOES NOT IMPROVE CLINICAL OUTCOMES IN PATIENTS PRESENTING WITH CONGESTIVE HEART FAILURE, AN ANALYSIS OF THE CORAL TRIAL.

In some guidelines congestive heart failure is an indication for renal artery stenting. We sought to determine, in patients enrolled with a history of congestive heart failure (CHF), the effect of renal artery stenting on clinical outcomes in the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial.

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 ...

Randomized Trial of the Effect of Four Second-Generation Antipsychotics and One First-Generation Antipsychotic on Cigarette Smoking, Alcohol, and Drug Use in Chronic Schizophrenia.

No large-scale randomized trial has compared the effect of different second-generation antipsychotic drugs and any first-generation drug on alcohol, drug and nicotine use in patients with schizophrenia. The Clinical Antipsychotic Trial of Intervention Effectiveness study randomly assigned 1432 patients formally diagnosed with schizophrenia to four second-generation antipsychotic drugs (olanzapine, risperidone quetiapine, and ziprasidone) and one first-generation antipsychotic (perphenazine) and followed the...

9C.08: HEART RATE AS A PREDICTOR OF CARDIOVASCULAR OUTCOMES: NEW EVIDENCE FROM THE ACTION TRIAL DATABASE.

Received wisdom suggests that treatments which reduce heart rate (HR), or avoid cardio-acceleration, are associated with improved cardiovascular (CV) outcomes. However, in the SIGNIFY trial in 12,049 patients with symptomatic angina, a sub-group analysis demonstrated a small but significant increase in the combined risk of CV death or non-fatal MI with the new anti-anginal agent, ivabradine, which is designed to reduce heart rate. The safety and efficacy of the long-acting calcium channel blocker, Nifedipin...

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...

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...



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