Efficacy and safety of oral propranolol for infantile hemangioma in Japan.
Pediatr Int
; 59(8): 869-877, 2017 Aug.
Article
em En
| MEDLINE
| ID: mdl-28453894
ABSTRACT
BACKGROUND:
There have been few reports on the efficacy and safety of oral propranolol at 3 mg/kg/day for infantile hemangioma (IH) in Japanese patients.METHODS:
A multicenter, open-label phase III study was conducted to evaluate the efficacy and safety of oral propranolol solution in Japanese infants aged 35-150 days with proliferating IH. Thirty-two patients were enrolled in the study, received propranolol solution for 24 weeks at 3 mg/kg/day, and completed the study.RESULTS:
The success rate (complete or nearly complete resolution) at week 24 (primary endpoint) was 78% (95%CI 60-91%). The improvement rate since the previous visit was 100% (32/32) after week 5. Overall, the IH surface area, maximum diameter, and color intensity all decreased over time. Consistency in assessment between the centralized and the investigator on-site assessments was observed in 26 patients. Of the 32 patients, 11 needed further treatment other than the study drug. The incidence of adverse events (AE) and drug-related AE was 97% and 31%, respectively. AE that occurred in ≥two patients were either typical of propranolol use (such as blood pressure decrease) or common events in infants. AE that resulted in dose reduction were observed in two patients, but no serious AE or AE that led to study drug discontinuation were observed.CONCLUSION:
Oral propranolol solution at 3 mg/kg/day is effective and safe in Japanese IH patients.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Propranolol
/
Hemangioma Capilar
/
Antagonistas Adrenérgicos beta
Tipo de estudo:
Clinical_trials
/
Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Limite:
Female
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Humans
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Infant
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Male
País/Região como assunto:
Asia
Idioma:
En
Revista:
Pediatr Int
Assunto da revista:
PEDIATRIA
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Japão