In an important study shedding light on pediatric cardiology, researchers have delved into the adverse drug reactions (ADRs) encountered by children with congenital heart disease (CHD). This investigation is crucial as it highlights the significant differences in drug reactions between children and adults, stressing the need for tailored medicinal approaches in young patients.
Research Methodology
A comprehensive scoping review was conducted in 2023, analyzing data from prominent databases including PubMed, Web of Science, Scopus, the Cochrane Library, Ovid, ProQuest, and Google Scholar. This study scrutinized all relevant articles published in English up to November 1, 2023, that reported ADRs in children with CHD. A total of 87 articles were meticulously reviewed, employing a content analysis method to derive significant findings.
Findings and Observations
The study revealed that the most common ADRs in children with CHD were symptoms, signs, and clinical findings related to cardiovascular disorders. Notably, drugs such as prostaglandin E1, amiodarone, prostaglandin E2, dexmedetomidine, and captopril were frequently associated with these adverse reactions. This is a crucial insight for market access stakeholders, as it underscores the necessity for pediatric-specific drug formulations and monitoring protocols.
Furthermore, the review highlighted the broad spectrum of ADRs affecting various body systems, including cardiovascular, respiratory, endocrine, metabolic, genitourinary, gastrointestinal, and musculoskeletal systems. This indicates a critical need for personalized treatment plans, considering the individual characteristics and vulnerabilities of pediatric patients.
Concrete Inferences for Market Access
Key Takeaways for Market Access:
- High incidence of ADRs necessitates stringent post-market surveillance for pediatric cardiovascular drugs.
- Market access strategies should include pediatric-specific clinical trials to ensure drug safety and efficacy for children with CHD.
- Collaboration with regulatory bodies to establish guidelines for pediatric drug use is essential for improving patient outcomes.
The study’s conclusion emphasizes the need for continued research and development in pediatric cardiology. Optimizing dosing regimens, understanding pharmacogenetic variables, and exploring alternative therapies are vital steps toward enhancing the management of CHD in children. These efforts will not only improve patient outcomes but also ensure safer and more effective drug utilization.
Original Article:
Paediatr Drugs. 2024 Jul 23. doi: 10.1007/s40272-024-00644-8. Online ahead of print.
ABSTRACT
BACKGROUND: Congenital heart disease (CHD) is one of the leading causes of death. Safe and timely medical interventions, especially in children, can prolong their survival. The drugs prescribed for children with CHD are mainly based on the outcomes of drug therapy in adults with cardiovascular diseases, and their adverse drug reactions (ADRs) might be different. Therefore, the aim of this study was to investigate ADRs in children with CHD.
METHODS: This was a scoping review conducted in 2023. PubMed, Web of Science, Scopus, the Cochrane Library, Ovid, ProQuest, and Google Scholar databases were searched. All studies that reported ADRs for children with CHD and were published in English by 1 November 2023 were included in this study. Finally, the results were reported using a content analysis method.
RESULTS: A total of 87 articles were included in the study. The results showed that symptoms/signs/clinical findings, and cardiovascular disorders were the most common ADRs reported in children with CHD. The results also showed that most of the ADRs were reported for prostaglandin E1, amiodarone, prostaglandin E2, dexmedetomidine, and captopril, respectively.
CONCLUSION: The review underscores the wide array of ADRs in children with CHD, particularly in antiarrhythmics, diuretics, beta-blockers, anticoagulants, and vasodilators, which affected cardiovascular, respiratory, endocrine, metabolic, genitourinary, gastrointestinal, and musculoskeletal systems. Tailored treatment is imperative, considering individual patient characteristics, especially in the vulnerable groups. Further research is essential for optimizing dosing, pharmacogenetics, and alternative therapies to enhance patient outcomes in CHD management.
PMID:39044096 | DOI:10.1007/s40272-024-00644-8
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