Azilsartan as an antihypertensive treatment in Japanese children under 6 years old: A phase 3 open-label long-term study.

backgroundPediatric hypertension presents unique challenges in its management and treatment. A previous study demonstrated the safety and efficacy of azilsartan in children 6-15 years old, but evaluation in children under 6 years old has not been conducted.

methodsThis phase 3, open-label study assessed the safety and efficacy of azilsartan in Japanese pediatric patients (2 to <6 years old) with hypertension. Patients received azilsartan once daily for 52 weeks, starting with 0.1 mg/kg and titrating up to a maximum of 0.8 mg/kg if target blood pressure (BP) had not been achieved. The primary objective was the incidence of treatment-emergent adverse events (TEAEs) and other safety parameters.

resultsAll nine patients who received azilsartan experienced TEAEs; most (88.9%) were mild-to-moderate in severity. Three patients (33.3%) experienced drug-related TEAEs (acute kidney injury, anemia, and renal impairment). Acute kidney injury was the only serious drug-related TEAE, which resolved following treatment interruption. There were no deaths or study discontinuations due to TEAEs. At weeks 12 and 52, mean (SD) changes in systolic BP from baseline (last observation carried forward) were -8.0 (6.7) and -10.9 (8.3) mmHg, respectively. The mean changes in diastolic BP from baseline were -10.9 (11.0) and -14.8 (8.4) mmHg, respectively. CONCLUSION(S): Azilsartan was generally well tolerated and associated with sustained BP reductions over 52 weeks in nine Japanese pediatric patients with hypertension. No new safety signals were identified. Our results indicate that azilsartan can be a therapeutic option for managing pediatric hypertension, potentially improving long-term cardiovascular outcomes.