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[Are the Spanish hypertensive children therapeutic orphans?]
C Morales-Carpi1, L Estañ Yago, I Torró Doménech
1Unidad Riesgo Cardiovascular, Servicio de Pediatría, Consorcio Hospital General Universitario, Valencia, Spain.
Insights
Pediatric hypertension treatment lacks sufficient drug information. The International Vademecum (I-V) provides guidance for only 5 antihypertensive drugs, leaving children as therapeutic orphans.
Area of Science:
- Pediatric Pharmacology
- Cardiovascular Medicine
- Drug Information Science
Context:
- Current guidelines recommend adult antihypertensive drugs for children, with dose adjustments for body size.
- The term "therapeutic orphans" highlights the scarcity of pediatric drug usage data.
- Investigating the adequacy of the International Vademecum (I-V) for pediatric antihypertensive drug use is crucial.
Purpose:
- To assess the sufficiency of the International Vademecum (I-V) for guiding the correct use of antihypertensive drugs in pediatric populations.
- To compare I-V data with established pediatric hypertension guidelines, such as the NHBPEP Fourth Report.
Summary:
- A review of 111 entries for 41 antihypertensive drugs in the I-V (44th & 45th editions) revealed limited pediatric information.
- Only 5 drug classes (3 diuretics, 2 ACE inhibitors) had available pediatric dosage information in the I-V.
- In contrast, the NHBPEP Fourth Report lists pediatric dosages for 28 drugs, and the FDA has approved 10 for pediatric use.
Impact:
- The I-V provides inadequate information for safe and effective pediatric antihypertensive drug dosing.
- Children remain "therapeutic orphans" due to the lack of comprehensive drug information for their age group.
- This study underscores the need for improved drug data accessibility for pediatric hypertension management.
Introduction:
According to current guidelines, hypertension in children should be treated with the same drugs as those used in adults, with adjustment of the dose to their body size. The term therapeutic orphans refers to the lack of information on how to use drugs in children. The aim of this study was to investigate whether the information in the International Vademecum (I-V) is sufficient for the correct use of antihypertensive drugs in children.
Material And Method:
We reviewed the data on pediatric dosages of antihypertensive drugs in the I-V (44th and 45th editions). When there were several drugs for the same molecule, the last one marked with the Spanish Ministry of Health and Consumption's logo was selected. When information on a particular drug was not available, the entries for other drugs with the same active principle were reviewed. The information was compared with that provided by the Fourth Report of the National High Blood Pressure Education Program Working Group (NHBPEP).
Results:
A total of 111 entries for 41 antihypertensive drugs were reviewed. Information on use in children is available for only 3 diuretics and 2 angiotensin converting enzyme inhibitors. The remaining entries either contain no information or indicate that the effectiveness and safety in children has not been evaluated. Some drugs are contraindicated in children. The Fourth Report of the NHBPEP includes pediatric dosages for 28 antihypertensive drugs. The Food and Drug Administration has authorized 10 antihypertensive drugs for use in children.
Conclusions:
The information in the V-I can be used to determine the correct dosage of only 5 antihypertensive drugs in children, making this age group authentic therapeutic orphans.
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