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22:33 EST 28th November 2014 | BioPortfolio

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

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GenomeVISTA - an integrated software package for whole-genome alignment and visualization.

With the ubiquitous generation of complete genome assemblies for a variety of species, efficient tools for whole-genome alignment along with user-friendly visualization are critically important. Our VISTA family of tools for comparative genomics, based on algorithms for pairwise and multiple alignments of genomic sequences and whole-genome assemblies have become one of the standard techniques for comparative analysis. Most of the VISTA programs have been implemented as Web-accessible servers and are extensi...

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...


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.

Relationship between heart rate and mortality and morbidity in the irbesartan patients with heart failure and preserved systolic function trial (I-Preserve).

Higher heart rate is associated with poorer outcomes in patients with heart failure and reduced ejection fraction (HF-REF). Less is known about the association between heart rate and outcomes in patients with heart failure and preserved ejection fraction (HF-PEF). Therefore, we examined the relationship between heart rate and outcomes in the irbesartan in patients with heart failure and preserved systolic function trial (I-Preserve) in patients with an ejection fraction >45% aged >60 years.

International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial.

The implications of geographical variation are unknown following adjustment for hospital length of stay (LOS) in heart failure (HF) trials that included patients whether or not they had systolic dysfunction. We investigated regional differences in an international acute HF trial.

Pharmacokinetics of Lacosamide and Omeprazole Coadministration in Healthy Volunteers: Results from a Phase I, Randomized, Crossover Trial.

The antiepileptic drug lacosamide has a low potential for drug-drug interactions, but is a substrate and moderate inhibitor of the cytochrome P450 (CYP) enzyme CYP2C19.

Chinese medicine shensongyangxin is effective for patients with bradycardia: results of a randomized, double-blind, placebo-controlled multicenter trial.

To evaluate the efficacy and safety of Shensong Yangxin (SSYX) in patients with bradycardia arrhythmias, a randomized, double-blind, and placebo-controlled study was conducted. Patients with bradycardia were randomly assigned to receive either SSYX (trial group, n = 115) or placebo (control group, n = 104) for 4 weeks. ECG, 24-hour continuous ECG recording, echocardiography, and hepatic and renal function were evaluated at baseline and after treatment. Results showed that the average heart rate, the fastest...

Adverse effects of benfluorex on heart valves and pulmonary circulation.

Benfluorex is responsible for the development of restrictive valvular regurgitation due to one of its metabolites, norfenfluramine. The 5-HT2B receptor, expressed on heart valves, acts as culprit receptor for drug-induced valvular heart disease (VHD). Stimulation of this receptor leads to the upregulation of target genes involved in the proliferation and stimulation of valvular interstitial cells through different intracellular pathways. Valve lesions essentially involve the mitral and/or aortic valves. The...

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 ...

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 ...

Drug Use Trajectories After a Randomized Controlled Trial of MTFC: Associations with Partner Drug Use.

Trajectories of drug use were examined in a sample of women with prior juvenile-justice system involvement. One hundred fifty-three young women who participated in a randomized controlled trial of Multidimensional Treatment Foster Care (MTFC) in adolescence were assessed on five occasions over a 24-month period in young adulthood (mean age = 22.29 years at T1). Participants assigned to the MTFC condition during adolescence reported greater decreases in drug use than girls assigned to the treatment as usual ...

Risk-benefit assessment of ivabradine in the treatment of chronic heart failure.

Heart rate is not only a major risk marker in heart failure but also a general risk marker. Within the last few years, it has been demonstrated that reduction of resting heart rate to

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.

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...

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...

Prognosis and response to therapy of first inpatient and outpatient heart failure event in a heart failure clinical trial: MADIT-CRT.

Hospitalization for worsening heart failure (HF) is known to increase mortality and morbidity risk and has been frequently used as an endpoint in randomized clinical trials. Whether outpatient management of HF exacerbation carries similar prognostic and therapeutic information is less well known, but could be important for the design of trials that use HF hospitalization as an endpoint.

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).

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 ...

A pilot study of target weight guided treatment in acute heart failure using ultrafiltration or usual care: effect on sodium removal.

In the Ultrafiltration versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure trial, ultrafiltration (UF) removed volume more effectively than usual care (UC). Hypothetically, UF may be superior to UC due to increased sodium (Na) removal and less neurohormonal activation. We compared UF and UC in a randomized pilot trial of target weight guided therapy for acute decompensated heart failure (ADHF).

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...

Healthcare transition for youth with heart disease: a clinical trial.

Adolescents with heart disease have complex health needs and require lifelong cardiology follow-up. Interventions to facilitate paediatric to adult healthcare transition are recommended, although outcomes are unknown. We sought to determine the impact of a transition intervention on improving knowledge and self-management skills among this population.

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...

Metformin in Diabetic Patients with Heart Failure: Safe and Effective?

Management of diabetic patients with heart failure is a complex endeavor. The initial reluctance to use metformin in these patients has given way to a broader acceptance after clinical trials and meta-analyses have revealed that some of the insulin-sensitizing agents lead to adverse cardiovascular events. We have proposed that an increase of substrate uptake by the insulin-resistant heart is detrimental because the heart is already flooded with fuel. In light of this evidence, metformin offers a unique safe...

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