Trends in the off‐label use of β‐blockers in pediatric patients

Kaley, Vishal R.; Aregullin, E. Oliver; Samuel, Bennett P.; Vettukattil, Joseph J.

doi:10.1111/ped.14015

Cited by 11 publications

(12 citation statements)

References 85 publications

(152 reference statements)

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“…Although treatment guidelines and reviews establish levels of evidence of treatment modalities, they often do not clearly distinguish ARTICLE between authorized and off-label used drugs or are usually limited by the number of drugs and/or indications. An example of such a smaller study supporting our findings is the study by Kaley et al 24 concluding that for βblockers in various cardiac and vascular conditions in children, for most indications only moderate to lowevidence is available. Interestingly, the situation for adult off-label prescribing appears more favorable.…”

Section: Discussionsupporting

confidence: 81%

See 1 more Smart Citation

Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy

Zanden

Smeets

Hoop-Sommen

et al. 2022

Clin Pharma and Therapeutics

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This study shows that the level of evidence for off-label pediatric pharmacotherapy is low: for only 14% of off-label records, high quality studies are available. Thirty-seven percent of offlabel records are not supported by any clinical studies at all. HOW MIGHT THIS CHANGE CLINICAL PHARMA COLOGY OR TRANSLATIONAL SCIENCE? Performing high quality randomized controlled trials for the > 2,000 off-label record is a very long pathway to close this information gap. Alternatively, modeling and simulation may be valuable approaches to strengthen the evidence base for offlabel use of drugs, especially in younger age groups.

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Section: Discussionsupporting

confidence: 81%

“…An example of such a smaller study supporting our findings is the study by Kaley et al . 24 concluding that for β‐blockers in various cardiac and vascular conditions in children, for most indications only moderate to low‐evidence is available. Interestingly, the situation for adult off‐label prescribing appears more favorable.…”

Section: Discussionmentioning

confidence: 99%

Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy

Zanden

Smeets

Hoop-Sommen

et al. 2022

Clin Pharma and Therapeutics

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show abstract

“…Without another choice, off-label use is a widespread and common practice for paediatrician [14,15], without implying improper or illegal drug use [16]. Importantly, off-label use does not exclude that there is extensive clinical experience and also data for the intended use [17]. For some drugs, there is recent scientific data of high quality and ample experience for the dosage used in practice which may deviate from the information in the SmPC [18].…”

Section: Introductionmentioning

confidence: 99%

Development of the Swiss Database for dosing medicinal products in pediatrics

Tilen

Panis²,

Aeschbacher³

et al. 2021

Eur J Pediatr

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In daily paediatrics, drugs are commonly used off-label, as they are not approved for children. Approval is lacking because the required clinical studies were limited to adults in the past. Without clinical studies, evidence-based recommendations for drug use in children are limited. Information on off-label drug dosing in children can be found in different handbooks, databases and scientific publications but the dosing recommendations can differ considerably. To improve safety and efficacy of drugs prescribed to children and to assist the prescribers, stakeholders in Swiss paediatrics started a pilot project, supported by the Federal Office of Public Health, with the aim to create a database, providing healthcare professionals with so called “harmonised” dosage recommendations based on the latest available scientific evidence and best clinical practice. A standardised process for dosage harmonisation between paediatric experts was defined, guided and documented in an electronic tool, developed for this purpose. As proof of principle, a total of 102 dosage recommendations for 30 different drugs have been nationally harmonised in the pilot phase considering the current scientific literature and the approval of the most experienced national experts in the field.Conclusion: This approach paved the way for unified national dosage recommendations for children. Reaching the project’s milestones fulfilled the prerequisites for funding and starting regular operation of SwissPedDose in 2018. Since then, the database was extended with recommendations for 100 additional drugs. What is Known:• Prescribing off-label is a common practice among paediatricians, as many drugs are still not authorised for use in children.• Some countries developed national drug formularies providing off-label dosage recommendations. What is New:• Comparison of published dosage recommendations in known drug handbooks and online databases show substantial differences and heterogeneity, revealing the need for harmonisation.• The design of a tool for standardised harmonisation of dosage recommendations, based on information collected on currently applied dosages, latest scientific evidence and the approval of experts.

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“…Recently, some studies have demonstrated that CHDs also affect myocardial cell division and cytokinesis, i.e., phenomena that can be prevented with beta-blockers [ 24 ]. In particular, beta-blockers have a wide array of labeled and off-label cardiovascular indications ( Table 1 ) [ 25 ]. Over time, three generations of them have been marketed for treating hypertension and heart failure [ 26 ].…”

Section: Drugs For Chd Treatmentmentioning

confidence: 99%

Congenital Heart Disease: The State-of-the-Art on Its Pharmacological Therapeutics

Varela-Chinchilla

Sánchez-Mejía

Trinidad-Calderón

2022

JCDD

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Congenital heart disease is one of the most common causes of death derived from malformations. Historically, its treatment has depended on timely diagnosis and early pharmacological and surgical interventions. Survival rates for patients with this disease have increased, primarily due to advancements in therapeutic choices, but mortality remains high. Since this disease is a time-sensitive pathology, pharmacological interventions are needed to improve clinical outcomes. Therefore, we analyzed the applications, dosage, and side effects of drugs currently used for treating congenital heart disease. Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, and potassium-sparing diuretics have shown a mortality benefit in most patients. Other therapies, such as endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostaglandins, and soluble guanylyl cyclase stimulators, have benefited patients with pulmonary artery hypertension. Likewise, the adjunctive symptomatic treatment of these patients has further improved the outcomes, since antiarrhythmics, digoxin, and non-steroidal anti-inflammatory drugs have shown their benefits in these cases. Conclusively, these drugs also carry the risk of troublesome adverse effects, such as electrolyte imbalances and hemodynamic compromise. However, their benefits for survival, symptom improvement, and stabilization outweigh the possible complications from their use. Thus, cases must be assessed individually to accurately identify interventions that would be most beneficial for patients.

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Trends in the off‐label use of β‐blockers in pediatric patients

Cited by 11 publications

References 85 publications

Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy

Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy

Development of the Swiss Database for dosing medicinal products in pediatrics

Congenital Heart Disease: The State-of-the-Art on Its Pharmacological Therapeutics

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