Safety and effectiveness of peramivir in Korean adult influenza patients: Prospective observational study based on post-marketing surveillance data

Wonseok Choi, 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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Article numbere212
JournalJournal of Korean Medical Science
Volume33
Issue number32
DOIs
Publication statusPublished - 2018 Aug 1

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Marketing
Human Influenza
Observational Studies
Prospective Studies
Safety
peramivir
Fever

Keywords

  • Antiviral
  • Clinical trial
  • Effectiveness
  • Influenza
  • Peramivir
  • Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Safety and effectiveness of peramivir in Korean adult influenza patients : Prospective observational study based on post-marketing surveillance data. / Choi, Wonseok; Ryu, Seong Yeol; Lee, Jacob; Hong, Sang Bum; Eom, Joong Sik; Shin, Jonghwan; Park, Ki Ho; Ohk, Taekgeun; Chung, Jin Won; Chung, Doo Ryeon; Kim, Dong Kee; Lee, Sang Rok; Kim, Pill Young; Kim, Shin Woo; Noh, Ji Yun; Song, Joon-Young; Cheong, Hee-Jin; Kim, Woo Joo.

In: Journal of Korean Medical Science, Vol. 33, No. 32, e212, 01.08.2018.

Research output: Contribution to journalArticle

Choi, Wonseok ; Ryu, Seong Yeol ; Lee, Jacob ; Hong, Sang Bum ; Eom, Joong Sik ; Shin, Jonghwan ; Park, Ki Ho ; Ohk, Taekgeun ; Chung, Jin Won ; Chung, Doo Ryeon ; Kim, Dong Kee ; Lee, Sang Rok ; Kim, Pill Young ; Kim, Shin Woo ; Noh, Ji Yun ; Song, Joon-Young ; Cheong, Hee-Jin ; Kim, Woo Joo. / Safety and effectiveness of peramivir in Korean adult influenza patients : Prospective observational study based on post-marketing surveillance data. In: Journal of Korean Medical Science. 2018 ; Vol. 33, No. 32.
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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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T1 - Safety and effectiveness of peramivir in Korean adult influenza patients

T2 - Prospective observational study based on post-marketing surveillance data

AU - Choi, Wonseok

AU - Ryu, Seong Yeol

AU - Lee, Jacob

AU - Hong, Sang Bum

AU - Eom, Joong Sik

AU - Shin, Jonghwan

AU - Park, Ki Ho

AU - Ohk, Taekgeun

AU - Chung, Jin Won

AU - Chung, Doo Ryeon

AU - Kim, Dong Kee

AU - Lee, Sang Rok

AU - Kim, Pill Young

AU - Kim, Shin Woo

AU - Noh, Ji Yun

AU - Song, Joon-Young

AU - Cheong, Hee-Jin

AU - Kim, Woo Joo

PY - 2018/8/1

Y1 - 2018/8/1

N2 - 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.

AB - 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.

KW - Antiviral

KW - Clinical trial

KW - Effectiveness

KW - Influenza

KW - Peramivir

KW - Safety

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