Therapeutic efficacy and safety of ACE inhibitors in the hypertensive paediatric population: a review

Abstract

Paediatric Nephrology (3K12D), Ghent University Hospital Ghent, BELGIUM -Contact: evelien.snauwaert@uzgent.be A literature search was performed in PubMed, including abstracts from 1980 to April 2015. Search terms hypertension, child, paediatric, ACE (inhibitors), RAAS and kallikrein-kinin sytem, and following drugs: captopril, lisinopril, enalapril, ramipril and fosinopril. + "snowball method" Inclusion intervention studies, observational studies and reviews of ACE inhibitors in hypertensive children (0-18 years) Exclusion not published in English, editorial pieces and opinions were excluded. InformationDesign, number of patients, age, ACE inhibitor, dose, formulation, primary end-points and adverse events. MethodsThe recent legislative initiatives increased the availability of paediatric labelling of ACE inhibitors. Nevertheless, many drugs used by hypertensive children have an insufficiently mapped out efficacy and safety profile and lack paediatric labelling. Moreover, many clinical questions remain and consequently complicate the selection of the most appropriate and effective ACE inhibitor in hypertensive children. The legislative initiatives also failed to fulfil several of paediatric needs: absence of long-term safety data on growth and maturation, absence of commercially available child-friendly formulations and incomplete evaluation of the entire paediatric hypertension population. Additional efforts are needed to close the gap between the availability of drugs that are labelled and indicated for paediatric use and the actual drug usage in children, especially in young children, neonates and children with severe hypertension, renal transplantation or severe renal impairment. ConclusionsSince 1997, strong incentives have been introduced worldwide to improve access to safe and effective medicines addressing the therapeutic needs of children.Angiotensin-1 converting enzyme (ACE) inhibitors = Most prescribed antihypertensive drugs in the paediatric population = Prototype drugs targeted by the legislation initiativesEvaluate and describe the current evidence of the efficacy and safety profile of ACE inhibitors in the paediatric populationBackground & purpose

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