Safety and efficacy of azilsartan in paediatric patients with hypertension: a phase 3, single-arm, open-label, prospective study View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-11-27

AUTHORS

Shuichi Ito, Yuya Nishiyama, Kenkichi Sugiura, Kazuaki Enya

ABSTRACT

BackgroundAzilsartan is an angiotensin II receptor blocker indicated for the treatment of adult hypertension. A previous single-dose study suggested that azilsartan may also be a promising agent for paediatric hypertension. However, the long-term safety and efficacy of azilsartan in children have not been established.MethodsWe conducted a phase 3, single-arm, open-label, prospective study to evaluate the safety and efficacy of azilsartan in pediatric patients with hypertension. Twenty-seven patients aged 6–15 years were treated with once-daily azilsartan for 52 weeks. The starting dose was 2.5 mg for patients weighing < 50 kg (N = 22) and 5 mg for patients weighing ≥ 50 kg (N = 5), with doses titrated up to a maximum of 20 and 40 mg, respectively.ResultsAzilsartan showed acceptable tolerability at doses up to 20 mg in patients weighing < 50 kg and 40 mg in those weighing ≥ 50 kg. Most drug-related adverse events (AEs) were mild, with one patient (3.7%) experiencing a severe and serious drug-related AE (acute kidney injury). One patient (3.7%) had a mild increase in serum creatinine level, which resolved after treatment discontinuation. The blood pressure-lowering effect of azilsartan was observed as early as Week 2. Overall, approximately half of the patients achieved their target blood pressure at the end of azilsartan treatment.ConclusionsOur study suggests that azilsartan has an acceptable safety profile in hypertensive patients aged 6–15 years. Azilsartan may be a promising agent for treating paediatric hypertension. More... »

PAGES

350-358

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10157-021-02159-9

DOI

http://dx.doi.org/10.1007/s10157-021-02159-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1143322812

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/34837606


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