J Korean Med Sci.
2018 Aug;33(32):e212. 10.3346/jkms.2018.33.e212.
Safety and Effectiveness of Peramivir in Korean Adult Influenza Patients: Prospective Observational Study Based on Post-Marketing Surveillance Data
- Choi WS
- Ryu SY
- Lee J
- Hong SB
- Eom JS
- Shin J
- Park KH
- Ohk T
- Chung JW
- Chung DR
- Kim DK
- Lee SR
- Kim PY
- Kim SW
- Noh JY
- Song JY
- Cheong HJ
- Kim WJ
- Affiliations
-
- 1Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. wjkim@korea.ac.kr
- 2Department of Infectious Diseases, Keimyung University Dongsan Medical Center, Daegu, Korea.
- 3Division of Infectious Diseases, Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
- 4Department of Pulmonary and Critical Care Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
- 5Division of Infectious Diseases, Department of Internal Medicine, Gachon University College of Medicine, Incheon, Korea.
- 6Department of Emergency Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
- 7Kim & Park Heart & Digestive Disease Clinic, Siheung, Korea.
- 8Department of Emergency Medicine, School of Medicine, Kangwon National University, Chuncheon, Korea.
- 9Division of Infectious Diseases, Chung-Ang University Hospital, Seoul, Korea.
- 10Division of Infectious Diseases, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 11Songdo Green Clinic, Incheon, Korea.
- 12Cheongju St. Mary's Hospital, Cheongju, Korea.
- 13Kim's Internal Medicine Clinic, Daegu, Korea.
- 14Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.
- KMID: 2417916
- DOI: http://doi.org/10.3346/jkms.2018.33.e212
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.
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