Ontology type: schema:ScholarlyArticle Open Access: True
2021-11-27
AUTHORSShuichi Ito, Yuya Nishiyama, Kenkichi Sugiura, Kazuaki Enya
ABSTRACTBackgroundAzilsartan 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. More... »
PAGES350-358
http://scigraph.springernature.com/pub.10.1007/s10157-021-02159-9
DOIhttp://dx.doi.org/10.1007/s10157-021-02159-9
DIMENSIONShttps://app.dimensions.ai/details/publication/pub.1143322812
PUBMEDhttps://www.ncbi.nlm.nih.gov/pubmed/34837606
JSON-LD is the canonical representation for SciGraph data.
TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT
[
{
"@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json",
"about": [
{
"id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11",
"inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/",
"name": "Medical and Health Sciences",
"type": "DefinedTerm"
},
{
"id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103",
"inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/",
"name": "Clinical Sciences",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Adolescent",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Antihypertensive Agents",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Benzimidazoles",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Blood Pressure",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Child",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Humans",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Hypertension",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Oxadiazoles",
"type": "DefinedTerm"
},
{
"inDefinedTermSet": "https://www.nlm.nih.gov/mesh/",
"name": "Prospective Studies",
"type": "DefinedTerm"
}
],
"author": [
{
"affiliation": {
"alternateName": "Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan",
"id": "http://www.grid.ac/institutes/grid.268441.d",
"name": [
"Department of Pediatrics, Yokohama City University, Yokohama, Kanagawa, Japan"
],
"type": "Organization"
},
"familyName": "Ito",
"givenName": "Shuichi",
"id": "sg:person.012302533312.63",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.012302533312.63"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan",
"id": "http://www.grid.ac/institutes/grid.419841.1",
"name": [
"Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan"
],
"type": "Organization"
},
"familyName": "Nishiyama",
"givenName": "Yuya",
"id": "sg:person.014650621104.15",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.014650621104.15"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan",
"id": "http://www.grid.ac/institutes/grid.419841.1",
"name": [
"Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan"
],
"type": "Organization"
},
"familyName": "Sugiura",
"givenName": "Kenkichi",
"id": "sg:person.0641711777.38",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0641711777.38"
],
"type": "Person"
},
{
"affiliation": {
"alternateName": "Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan",
"id": "http://www.grid.ac/institutes/grid.419841.1",
"name": [
"Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan"
],
"type": "Organization"
},
"familyName": "Enya",
"givenName": "Kazuaki",
"id": "sg:person.0732636546.77",
"sameAs": [
"https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0732636546.77"
],
"type": "Person"
}
],
"citation": [
{
"id": "sg:pub.10.1038/s41440-019-0284-9",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1120027740",
"https://doi.org/10.1038/s41440-019-0284-9"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1007/s12325-018-0754-5",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1105711596",
"https://doi.org/10.1007/s12325-018-0754-5"
],
"type": "CreativeWork"
},
{
"id": "sg:pub.10.1038/hr.2012.8",
"sameAs": [
"https://app.dimensions.ai/details/publication/pub.1023270793",
"https://doi.org/10.1038/hr.2012.8"
],
"type": "CreativeWork"
}
],
"datePublished": "2021-11-27",
"datePublishedReg": "2021-11-27",
"description": "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\u201315\u00a0years were treated with once-daily azilsartan for 52\u00a0weeks. The starting dose was 2.5\u00a0mg for patients weighing\u2009<\u200950\u00a0kg (N\u2009=\u200922) and 5\u00a0mg for patients weighing\u2009\u2265\u200950\u00a0kg (N\u2009=\u20095), with doses titrated up to a maximum of 20 and 40\u00a0mg, respectively.ResultsAzilsartan showed acceptable tolerability at doses up to 20\u00a0mg in patients weighing\u2009<\u200950\u00a0kg and 40\u00a0mg in those weighing\u2009\u2265\u200950\u00a0kg. 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\u201315\u00a0years. Azilsartan may be a promising agent for treating paediatric hypertension.",
"genre": "article",
"id": "sg:pub.10.1007/s10157-021-02159-9",
"inLanguage": "en",
"isAccessibleForFree": true,
"isPartOf": [
{
"id": "sg:journal.1117096",
"issn": [
"1342-1751",
"1437-7799"
],
"name": "Clinical and Experimental Nephrology",
"publisher": "Springer Nature",
"type": "Periodical"
},
{
"issueNumber": "4",
"type": "PublicationIssue"
},
{
"type": "PublicationVolume",
"volumeNumber": "26"
}
],
"keywords": [
"efficacy of azilsartan",
"drug-related adverse events",
"adverse events",
"pediatric hypertension",
"pediatric patients",
"prospective study",
"Most drug-related adverse events",
"serious drug-related adverse events",
"previous single-dose study",
"angiotensin II receptor blockers",
"blood pressure-lowering effect",
"promising agent",
"serum creatinine levels",
"target blood pressure",
"II receptor blockers",
"pressure-lowering effect",
"acceptable safety profile",
"single-dose study",
"long-term safety",
"phase 3",
"adult hypertension",
"azilsartan treatment",
"receptor blockers",
"starting dose",
"treatment discontinuation",
"hypertensive patients",
"acceptable tolerability",
"creatinine levels",
"blood pressure",
"safety profile",
"hypertension",
"patients",
"week 2",
"mild increase",
"ConclusionsOur study",
"azilsartan",
"efficacy",
"doses",
"treatment",
"safety",
"tolerability",
"discontinuation",
"blockers",
"years",
"agents",
"MethodsWe",
"study",
"dose",
"weeks",
"children",
"levels",
"half",
"events",
"increase",
"effect",
"profile",
"pressure",
"end",
"maximum"
],
"name": "Safety and efficacy of azilsartan in paediatric patients with hypertension: a phase 3, single-arm, open-label, prospective study",
"pagination": "350-358",
"productId": [
{
"name": "dimensions_id",
"type": "PropertyValue",
"value": [
"pub.1143322812"
]
},
{
"name": "doi",
"type": "PropertyValue",
"value": [
"10.1007/s10157-021-02159-9"
]
},
{
"name": "pubmed_id",
"type": "PropertyValue",
"value": [
"34837606"
]
}
],
"sameAs": [
"https://doi.org/10.1007/s10157-021-02159-9",
"https://app.dimensions.ai/details/publication/pub.1143322812"
],
"sdDataset": "articles",
"sdDatePublished": "2022-05-10T10:30",
"sdLicense": "https://scigraph.springernature.com/explorer/license/",
"sdPublisher": {
"name": "Springer Nature - SN SciGraph project",
"type": "Organization"
},
"sdSource": "s3://com-springernature-scigraph/baseset/20220509/entities/gbq_results/article/article_922.jsonl",
"type": "ScholarlyArticle",
"url": "https://doi.org/10.1007/s10157-021-02159-9"
}
]Download the RDF metadata as: json-ld nt turtle xml License info
JSON-LD is a popular format for linked data which is fully compatible with JSON.
curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s10157-021-02159-9'
N-Triples is a line-based linked data format ideal for batch operations.
curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s10157-021-02159-9'
Turtle is a human-readable linked data format.
curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s10157-021-02159-9'
RDF/XML is a standard XML format for linked data.
curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s10157-021-02159-9'
This table displays all metadata directly associated to this object as RDF triples.
193 TRIPLES
22 PREDICATES
97 URIs
86 LITERALS
16 BLANK NODES