Therapeutic efficacy and safety of ACE inhibitors in the hypertensive paediatric population: a review.
OBJECTIVE
Since 1997, strong incentives have been introduced worldwide to improve access to safe and effective medicines addressing the therapeutic needs of children. ACE inhibitors, the most prescribed antihypertensive drugs in the paediatric population, are one of the prototype drugs targeted by the legislation initiatives. Our purpose in assembling this review is to evaluate and describe the current evidence for the efficacy and safety profile of ACE inhibitors in the paediatric population.


METHODS
The authors made a descriptive review of the literature from 1980 to 2015 using the following search terms: hypertension, child, paediatric, ACE (inhibitors), renin-angiotensin aldosterone system, captopril, lisinopril, enalapril, ramipril and fosinopril.


RESULTS
A total of 16 studies evaluating efficacy and safety of ACE inhibitors were included in this review. The included studies demonstrate that ACE inhibitors have the potency to decrease the systolic and/or diastolic blood pressure with an overall favourable safety profile in a short-term period. More importantly, the incentives resulted in an improvement of the overall availability of paediatric labelling, dosing and safety information for ACE inhibitors. However, they 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.


CONCLUSIONS
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.
Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Science, Ghent University, Ghent, Belgium.
Evelien
http://orcid.org/0000-0003-2660-7460
E
Snauwaert
Paediatric Nephrology, Ghent University Hospital, Ghent, Belgium.
Johan
J
Vande Walle
Department of Paediatrics and Medical Genetics, Faculty of Medicine and Health Science, Ghent University, Ghent, Belgium.
Pauline
P
De Bruyne
D000293:Adolescent; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007223:Infant; D007231:Infant, Newborn; D016896:Treatment Outcome
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents
Hypertension; Pharmacology; angiotensin-converting enzyme inhibitor; child