PMID- 34837606
OWN - NLM
STAT- MEDLINE
DCOM- 20220404
LR  - 20220531
IS  - 1437-7799 (Electronic)
IS  - 1342-1751 (Print)
IS  - 1342-1751 (Linking)
VI  - 26
IP  - 4
DP  - 2022 Apr
TI  - Safety and efficacy of azilsartan in paediatric patients with hypertension: a 
      phase 3, single-arm, open-label, prospective study.
PG  - 350-358
LID - 10.1007/s10157-021-02159-9 [doi]
AB  - 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.
CI  - (c) 2021. The Authors.
FAU - Ito, Shuichi
AU  - Ito S
AUID- ORCID: 0000-0002-5242-8987
AD  - Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan.
FAU - Nishiyama, Yuya
AU  - Nishiyama Y
AD  - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, 
      Japan.
FAU - Sugiura, Kenkichi
AU  - Sugiura K
AD  - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, 
      Japan.
FAU - Enya, Kazuaki
AU  - Enya K
AD  - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, 
      Japan. kazuaki.enya@takeda.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20211127
PL  - Japan
TA  - Clin Exp Nephrol
JT  - Clinical and experimental nephrology
JID - 9709923
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Oxadiazoles)
RN  - F9NUX55P23 (azilsartan)
SB  - IM
EIN - Clin Exp Nephrol. 2022 Jan 13;:. PMID: 35024975
MH  - Adolescent
MH  - Antihypertensive Agents/adverse effects
MH  - *Benzimidazoles/adverse effects
MH  - Blood Pressure
MH  - Child
MH  - Humans
MH  - *Hypertension/diagnosis/drug therapy
MH  - *Oxadiazoles/adverse effects
MH  - Prospective Studies
PMC - PMC8930870
OTO - NOTNLM
OT  - Angiotensin II type 1 receptor blockers
OT  - Antihypertensive agent
OT  - Azilsartan
OT  - Paediatric hypertension
COIS- Honoraria: Shuichi Ito (Alexion pharma and Sanofi Genzyme). Research funding: 
      Shuichi Ito (Japan Blood Product Organization and Teijin Pharma). Employment: 
      Yuya Nishiyama, Kenkichi Sugiura, and Kazuaki Enya (Takeda Pharmaceutical Company 
      Limited).
EDAT- 2021/11/28 06:00
MHDA- 2022/04/05 06:00
PMCR- 2021/11/27
CRDT- 2021/11/27 12:07
PHST- 2021/07/15 00:00 [received]
PHST- 2021/11/05 00:00 [accepted]
PHST- 2021/11/28 06:00 [pubmed]
PHST- 2022/04/05 06:00 [medline]
PHST- 2021/11/27 12:07 [entrez]
PHST- 2021/11/27 00:00 [pmc-release]
AID - 10.1007/s10157-021-02159-9 [pii]
AID - 2159 [pii]
AID - 10.1007/s10157-021-02159-9 [doi]
PST - ppublish
SO  - Clin Exp Nephrol. 2022 Apr;26(4):350-358. doi: 10.1007/s10157-021-02159-9. Epub 
      2021 Nov 27.