Azilsartan as an antihypertensive treatment in Japanese children under 6 years old: A phase 3 open-label long-term
Shuichi Ito1, Masakazu Miyamoto2, Yuki Mizuta2
1Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan.
Insights
Azilsartan demonstrated good tolerability and sustained blood pressure reduction in Japanese children aged 2 to 6 years with hypertension over 52 weeks. No new safety concerns were identified, suggesting its potential as a treatment option.
Area of Science:
- Pediatric Nephrology
- Cardiovascular Pharmacology
- Clinical Drug Trials
Background:
- Pediatric hypertension management is challenging.
- Previous studies confirmed azilsartan safety in children 6-15 years old.
- Efficacy and safety in children under 6 years old remained unevaluated.
Purpose of the Study:
- To assess the safety and efficacy of azilsartan in Japanese pediatric patients aged 2 to <6 years with hypertension.
- To evaluate treatment-emergent adverse events (TEAEs) and other safety parameters.
- To determine the drug's impact on blood pressure over a 52-week period.
Main Methods:
- Phase 3, open-label study design.
- Nine Japanese pediatric patients (2 to <6 years old) with hypertension received daily azilsartan.
- Dosage ranged from 0.1 mg/kg, titrated up to 0.8 mg/kg if target blood pressure was not achieved.
- Treatment duration was 52 weeks.
Main Results:
- All patients experienced mild-to-moderate TEAEs; 33.3% had drug-related TEAEs (acute kidney injury, anemia, renal impairment).
- Acute kidney injury was the only serious drug-related TEAE, resolving upon treatment interruption.
- Sustained reductions in systolic and diastolic blood pressure were observed at weeks 12 and 52.
- No deaths or study discontinuations due to TEAEs occurred.
Conclusions:
- Azilsartan was generally well tolerated in Japanese pediatric patients aged 2 to <6 years.
- The drug was associated with sustained blood pressure reduction over 52 weeks.
- Azilsartan represents a potential therapeutic option for pediatric hypertension, possibly improving long-term cardiovascular outcomes.
Background:
Pediatric 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.
Methods:
This 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.
Results:
All 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.
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