Safety and Effectiveness of Peramivir in Korean Adult Influenza Patients: Prospective Observational Study Based on Post-Marketing Surveillance Data.
10.3346/jkms.2018.33.e212
- Author:
Won Suk CHOI
1
;
Seong Yeol RYU
;
Jacob LEE
;
Sang Bum HONG
;
Joong Sik EOM
;
Jonghwan SHIN
;
Ki Ho PARK
;
Taekgeun OHK
;
Jin Won CHUNG
;
Doo Ryeon CHUNG
;
Dong Kee KIM
;
Sang Rok LEE
;
Pill Young KIM
;
Shin Woo KIM
;
Ji Yun NOH
;
Joon Young SONG
;
Hee Jin CHEONG
;
Woo Joo KIM
Author Information
1. Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. wjkim@korea.ac.kr
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Influenza;
Antiviral;
Peramivir;
Safety;
Effectiveness;
Clinical Trial
- MeSH:
Adult*;
Fever;
Humans;
Influenza, Human*;
Observational Study*;
Prospective Studies*;
Seasons;
Treatment Outcome
- From:Journal of Korean Medical Science
2018;33(32):e212-
- CountryRepublic of Korea
- Language:English
-
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.
