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Safety and efficacy of azilsartan in paediatric patients with hypertension: a phase 3, single-arm, open-label, prospective study.
- Source :
-
Clinical & Experimental Nephrology . Apr2022, Vol. 26 Issue 4, p350-358. 9p. - Publication Year :
- 2022
-
Abstract
- Background: Azilsartan 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. Methods: We 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. Results: Azilsartan 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. 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CHILD patients
*HYPERTENSION
*ANGIOTENSIN-receptor blockers
Subjects
Details
- Language :
- English
- ISSN :
- 13421751
- Volume :
- 26
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Clinical & Experimental Nephrology
- Publication Type :
- Academic Journal
- Accession number :
- 155873786
- Full Text :
- https://doi.org/10.1007/s10157-021-02159-9