Safety and Effectiveness of Peramivir in Korean Adult Influenza Patients: Prospective Observational Study Based on Post-Marketing Surveillance Data
Journal of Korean Medical Science
;
: e212-2018.
Artículo
en Inglés
| WPRIM
| ID: wpr-716528
ABSTRACT
BACKGROUND:
The safety and clinical effectiveness data of peramivir in the real clinical field are limited. A prospective observational study was conducted based on the post-marketing surveillance data to evaluate the post-marketing safety and effectiveness of peramivir in Korean adults with seasonal influenza.METHODS:
Among adults aged 20 years or older who were diagnosed with influenza A or B, patients who started peramivir within 48 hours from the initial symptoms of influenza were enrolled. All adverse events (AEs) that occurred within 7 days after administration of peramivir were checked. For the evaluation of effectiveness, changes in the severity of influenza symptoms and daily living performance were examined before and 7 days after the administration of peramivir. The date on which influenza related symptoms disappeared was checked.RESULTS:
A total of 3,024 patients were enrolled for safety evaluation and 2,939 patients were for effectiveness evaluation. In the safety evaluation, 42 AEs were observed in 35 (1.16%) patients. The most common AE was fever. AEs were mostly rated as mild in severity. Serious AEs were observed in 10 patients and two of them died. However, both deaths were considered to be less relevant to peramivir. In the effectiveness evaluation, the severity of influenza symptoms decreased by 10.68 ± 4.01 points and daily living performance was improved 5.59 ± 2.16 points. Influenza related symptoms disappeared on average 3.02 ± 2.39 days after peramivir administration.CONCLUSION:
Peramivir showed a tolerable safety profile and acceptable effectiveness in Korean adult patients with seasonal influenza.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Estaciones del Año
/
Estudios Prospectivos
/
Resultado del Tratamiento
/
Gripe Humana
/
Fiebre
/
Estudio Observacional
Tipo de estudio:
Estudio observacional
/
Estudio de tamizaje
Límite:
Adulto
/
Humanos
Idioma:
Inglés
Revista:
Journal of Korean Medical Science
Año:
2018
Tipo del documento:
Artículo
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