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.
Highlights
Hypertension is a common chronic disease in Japanese children and adolescents, with a detection rate of 0.5–1% in elementary and junior high school students and 3% in high school students during school health check-ups [1, 2]
Our study suggests that azilsartan has an acceptable safety profile in hypertensive patients aged 6–15 years
Key exclusion criteria were: (1) poorly controlled hypertension indicated by an office sitting SBP higher by ≥ 15 mmHg and/or an office sitting DBP higher by ≥ 10 mmHg than the 99 percentiles of the reference blood pressure (BP) values of the patients by gender and age; (2) a diagnosis of malignant or accelerated hypertension; (3) noncompliance with the study drug during the run-in period
Summary
Hypertension is a common chronic disease in Japanese children and adolescents, with a detection rate of 0.5–1% in elementary and junior high school students and 3% in high school students during school health check-ups [1, 2]. Essential hypertension in children is associated with a high risk of organ damage, including kidney disease, cerebrovascular disorders and cardiovascular. Given the complications associated with chronic hypertension, it is critical to manage high blood pressure (BP) early in paediatric patients. For children with secondary hypertension, who commonly have comorbid diseases such as diabetes or chronic kidney disease (CKD), pharmacological therapy is generally recommended in the first line [6]. In patients requiring pharmacological therapy, monotherapy with an approved antihypertensive agent should be started at a low dose and increased up to the maximum approved dose until BP is normalised [6]. A previous single-dose study suggested that azilsartan may be a promising agent for paediatric hypertension. Conclusions Our 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
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