scholarly journals Current and Future Drug and Device Therapies for Pediatric Heart Failure Patients: Potential Lessons from Adult Trials

Children ◽  
2021 ◽  
Vol 8 (5) ◽  
pp. 322
Author(s):  
Bibhuti B. Das ◽  
William B. Moskowitz ◽  
Javed Butler
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Systolic Function ◽  
Lessons Learned ◽  
Pathophysiological Mechanism ◽  
Controlled Clinical Trials ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Future Drug ◽  
Pediatric Heart Failure ◽  
Selection Of

This review discusses the potential drug and device therapies for pediatric heart failure (HF) due to reduced systolic function. It is important to realize that most drugs that are used in pediatric HF are extrapolated from adult cardiology practices or consensus guidelines based on expert opinion rather than on evidence from controlled clinical trials. It is difficult to conclude whether the drugs that are well established in adult HF trials are also beneficial for children because of tremendous heterogeneity in the mechanism of HF in children and variations in the pharmacokinetics and pharmacodynamics of drugs from birth to adolescence. The lessons learned from adult trials can guide pediatric cardiologists to design clinical trials of the newer drugs that are in the pipeline to study their efficacy and safety in children with HF. This paper’s focus is that the reader should specifically think through the pathophysiological mechanism of HF and the mode of action of drugs for the selection of appropriate pharmacotherapy. We review the drug and device trials in adults with HF to highlight the knowledge gap that exists in the pediatric HF population.

scholarly journals Ignoring a basic pathophysiological mechanism of heart failure progression will not make it go away

2021 ◽  
Author(s):  
A. Martin Gerdes ◽  
Michael A. Portman ◽  
Giorgio Iervasi ◽  
Alessandro Pingitore ◽  
David KC Cooper ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Thyroid Hormone ◽  
Cardiac Patients ◽  
Steady Increase ◽  
Pathophysiological Mechanism ◽  
General Belief ◽  
Heart Patients ◽  
Heart Failure Progression

A link between heart failure (HF) and low thyroid hormone (TH) function has been known for over a century. Nonetheless, there is a general belief that TH treatment of HF patients may not be worth the risk. This is largely based on two clinical trials where heart patients were treated with excessive doses of TH analogs, not actual THs. Further complicating the issue is the fact that normalization of THs in non-cardiac patients can often be challenging. This issue is not going away as noted by a steady increase in TH-HF citations in recent years. In this article, we discuss what we know and how we may move the field forward.

Antibiotic Drug Levels

1995 ◽  
Vol 16 (11) ◽  
pp. 438-439
Author(s):  
Michael G. Rosenberg
Keyword(s):  
Clinical Trials ◽  
Antimicrobial Agents ◽  
Therapeutic Equivalence ◽  
Relative Toxicity ◽  
Antibiotic Regimen ◽  
Controlled Clinical Trials ◽  
The Past ◽  
Antibiotic Drug ◽  
New Compounds ◽  
Selection Of

In the past, efficacy, as defined by controlled clinical trials, was the primary factor in the selection of a particular antibiotic regimen. Today, as the number of antimicrobial agents approved for clinical use has grown almost exponentially, efficacy rarely is emphasized in published clinical trials. More commonly they demonstrate therapeutic equivalence rather than superiority of new compounds to previously accepted regimens. For this reason, the two criteria that now factor most prominently into the selection of equally effective antibiotics are relative toxicity and cost. Three major classes of antibiotics used throughout the world in the treatment of serious pediatric infectious diseases are chloramphenicol (CAP) and its derivatives, aminoglycosides (AGs), and vancomycin and related glycopeptides.

scholarly journals Heart Failure in Women: Epidemiology, Biology and Treatment

2009 ◽  
Vol 5 (5) ◽  
pp. 517-527 ◽  
Author(s):  
Rashmee U Shah ◽  
Liviu Klein ◽  
Donald M Lloyd-Jones
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Angiotensin Converting Enzyme ◽  
Enzyme Inhibitors ◽  
Systolic Function ◽  
Angiotensin Receptor Blockers ◽  
Significant Proportion ◽  
Angiotensin Converting Enzyme Inhibitors ◽  
Converting Enzyme ◽  
Converting Enzyme Inhibitors

Although women account for a significant proportion of the growing heart failure epidemic, they have been poorly represented in clinical trials. As emerging epidemiologic data reveal a growing prevalence and burden of disease among women, it is increasingly important that treating physicians and researchers recognize sex-based differences. Despite the overall incidence of heart failure being lower in women compared with men, the magnitude of improvement in survival over the last several decades has been less apparent in women. Women with heart failure are more likely to be older, have preserved systolic function and nonischemic cardiomyopathy. While clinical trials have demonstrated improved outcomes among heart failure patients, they have predominantly included men, yielding results that are sometimes inadequately powered to detect a benefit for women. Without adequate representation of women in clinical trials, one cannot assume that the same level of therapeutic evidence also applies to women. Nonetheless, it appears that β-blockers and angiotensin-converting enzyme inhibitors provide the same survival benefits in women with systolic dysfunction as in men. In addition, some studies suggest that angiotensin-receptor blockers may lead to a better survival in women when compared with angiotensin-converting enzyme inhibitors. Focused research is needed to understand and guide the management of women with heart failure.

scholarly journals Recent and Upcoming Drug Therapies for Pediatric Heart Failure

2021 ◽  
Vol 9 ◽  
Author(s):  
Karla L. Loss ◽  
Robert E. Shaddy ◽  
Paul F. Kantor
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Clinical Presentation ◽  
Pediatric Population ◽  
Systolic Dysfunction ◽  
Small Sample ◽  
New Drugs ◽  
High Morbidity ◽  
Reduced Ejection Fraction ◽  
Pediatric Heart Failure

Pediatric heart failure (HF) is an important clinical condition with high morbidity, mortality, and costs. Due to the heterogeneity in clinical presentation and etiologies, the development of therapeutic strategies is more challenging in children than adults. Most guidelines recommending drug therapy for pediatric HF are extrapolated from studies in adults. Unfortunately, even using all available treatment, progression to cardiac transplantation is common. The development of prospective clinical trials in the pediatric population has significant obstacles, including small sample sizes, slow recruitment rates, challenging endpoints, and high costs. However, progress is being made as evidenced by the recent introduction of ivabradine and of sacubitril/valsartan. In the last 5 years, new drugs have also been developed for HF with reduced ejection fraction (HFrEF) in adults. The use of well-designed prospective clinical trials will be fundamental in the evaluation of safety and efficacy of these new drugs on the pediatric population. The aim of this article is to review the clinical presentation and management of acute and chronic pediatric heart failure, focusing on systolic dysfunction in patients with biventricular circulation and a systemic left ventricle. We discuss the drugs recently approved for children and those emerging, or in use for adults with HFrEF.

Antibiotic Drug Levels

1995 ◽  
Vol 16 (10) ◽  
pp. 397-398
Author(s):  
Michael G. Rosenberg
Keyword(s):  
Clinical Trials ◽  
Antimicrobial Agents ◽  
Therapeutic Equivalence ◽  
Relative Toxicity ◽  
Antibiotic Regimen ◽  
Controlled Clinical Trials ◽  
The Past ◽  
Antibiotic Drug ◽  
New Compounds ◽  
Selection Of

In the past, efficacy, as defined by controlled clinical trials, was the primary factor in the selection of a particular antibiotic regimen. Today, as the number of antimicrobial agents approved for clinical use has grown almost exponentially, efficacy rarely is emphasized in published clinical trials. More commonly they demonstrate therapeutic equivalence rather than superiority of new compounds to previously accepted regimens. For this reason, the two criteria that now factor most prominently into the selection of equally effective antibiotics are relative toxicity and cost. Three major classes of antibiotics used throughout the world in the treatment of serious pediatric infectious diseases are chloramphenicol (CAP) and its derivatives, aminoglycosides (AGs), and vancomycin and related glycopeptides.

Sign in / Sign up

Export Citation Format

Share Document