PMID- 30079005
OWN - NLM
STAT- MEDLINE
DCOM- 20190307
LR  - 20220408
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 33
IP  - 32
DP  - 2018 Aug 6
TI  - Safety and Effectiveness of Peramivir in Korean Adult Influenza Patients: 
      Prospective Observational Study Based on Post-Marketing Surveillance Data.
PG  - e212
LID - 10.3346/jkms.2018.33.e212 [doi]
LID - e212
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.
FAU - Choi, Won Suk
AU  - Choi WS
AUID- ORCID: 0000-0001-5874-4764
AD  - Division of Infectious Diseases, Department of Internal Medicine, Korea 
      University College of Medicine, Seoul, Korea.
FAU - Ryu, Seong Yeol
AU  - Ryu SY
AUID- ORCID: 0000-0002-6023-8550
AD  - Department of Infectious Diseases, Keimyung University Dongsan Medical Center, 
      Daegu, Korea.
FAU - Lee, Jacob
AU  - Lee J
AUID- ORCID: 0000-0002-7041-065X
AD  - Division of Infectious Diseases, Department of Internal Medicine, Hallym 
      University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 
      Seoul, Korea.
FAU - Hong, Sang-Bum
AU  - Hong SB
AUID- ORCID: 0000-0003-2737-7695
AD  - Department of Pulmonary and Critical Care Medicine, University of Ulsan College 
      of Medicine, Asan Medical Center, Seoul, Korea.
FAU - Eom, Joong Sik
AU  - Eom JS
AUID- ORCID: 0000-0003-2744-1159
AD  - Division of Infectious Diseases, Department of Internal Medicine, Gachon 
      University College of Medicine, Incheon, Korea.
FAU - Shin, Jonghwan
AU  - Shin J
AUID- ORCID: 0000-0002-7121-2137
AD  - Department of Emergency Medicine, Seoul Metropolitan Government-Seoul National 
      University Boramae Medical Center, Seoul, Korea.
FAU - Park, Ki Ho
AU  - Park KH
AUID- ORCID: 0000-0002-2796-7145
AD  - Kim & Park Heart & Digestive Disease Clinic, Siheung, Korea.
FAU - Ohk, Taekgeun
AU  - Ohk T
AUID- ORCID: 0000-0003-1005-9893
AD  - Department of Emergency Medicine, School of Medicine, Kangwon National 
      University, Chuncheon, Korea.
FAU - Chung, Jin-Won
AU  - Chung JW
AUID- ORCID: 0000-0003-4811-6056
AD  - Division of Infectious Diseases, Chung-Ang University Hospital, Seoul, Korea.
FAU - Chung, Doo Ryeon
AU  - Chung DR
AUID- ORCID: 0000-0001-9267-101X
AD  - Division of Infectious Diseases, Samsung Medical Center, Sungkyunkwan University 
      School of Medicine, Seoul, Korea.
FAU - Kim, Dong Kee
AU  - Kim DK
AUID- ORCID: 0000-0002-1086-0245
AD  - Songdo Green Clinic, Incheon, Korea.
FAU - Lee, Sang-Rok
AU  - Lee SR
AUID- ORCID: 0000-0003-0657-4657
AD  - Cheongju St. Mary's Hospital, Cheongju, Korea.
FAU - Kim, Pill Young
AU  - Kim PY
AUID- ORCID: 0000-0002-9305-4301
AD  - Kim's Internal Medicine Clinic, Daegu, Korea.
FAU - Kim, Shin-Woo
AU  - Kim SW
AUID- ORCID: 0000-0002-3755-8249
AD  - Department of Internal Medicine, School of Medicine, Kyungpook National 
      University, Daegu, Korea.
FAU - Noh, Ji Yun
AU  - Noh JY
AUID- ORCID: 0000-0001-8541-5704
AD  - Division of Infectious Diseases, Department of Internal Medicine, Korea 
      University College of Medicine, Seoul, Korea.
FAU - Song, Joon Young
AU  - Song JY
AUID- ORCID: 0000-0002-0148-7194
AD  - Division of Infectious Diseases, Department of Internal Medicine, Korea 
      University College of Medicine, Seoul, Korea.
FAU - Cheong, Hee Jin
AU  - Cheong HJ
AUID- ORCID: 0000-0002-2532-1463
AD  - Division of Infectious Diseases, Department of Internal Medicine, Korea 
      University College of Medicine, Seoul, Korea.
FAU - Kim, Woo Joo
AU  - Kim WJ
AUID- ORCID: 0000-0002-4546-3880
AD  - Division of Infectious Diseases, Department of Internal Medicine, Korea 
      University College of Medicine, Seoul, Korea.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20180626
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (Acids, Carbocyclic)
RN  - 0 (Antiviral Agents)
RN  - 0 (Cyclopentanes)
RN  - 0 (Guanidines)
RN  - QW7Y7ZR15U (peramivir)
SB  - IM
CIN - J Korean Med Sci. 2018 Jul 25;33(32):e232. PMID: 30079007
MH  - Acids, Carbocyclic
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Cyclopentanes/adverse effects/*therapeutic use
MH  - Female
MH  - Guanidines/adverse effects/*therapeutic use
MH  - Humans
MH  - Influenza, Human/*drug therapy
MH  - Male
MH  - Marketing
MH  - Middle Aged
MH  - Prospective Studies
MH  - Republic of Korea
MH  - Young Adult
PMC - PMC6070467
OTO - NOTNLM
OT  - Antiviral
OT  - Clinical Trial
OT  - Effectiveness
OT  - Influenza
OT  - Peramivir
OT  - Safety
COIS- Disclosure: The sponsor participated in the post-marketing study design, 
      execution, and the data collections. Although the sponsor reviewed the draft, the 
      opinions expressed by the sponsor may not necessarily be reflected. The results 
      of this study were presented as a poster at the 5th ISIRV-AVG conference.
EDAT- 2018/08/07 06:00
MHDA- 2019/03/08 06:00
PMCR- 2018/08/06
CRDT- 2018/08/07 06:00
PHST- 2018/02/03 00:00 [received]
PHST- 2018/04/17 00:00 [accepted]
PHST- 2018/08/07 06:00 [entrez]
PHST- 2018/08/07 06:00 [pubmed]
PHST- 2019/03/08 06:00 [medline]
PHST- 2018/08/06 00:00 [pmc-release]
AID - 10.3346/jkms.2018.33.e212 [doi]
PST - epublish
SO  - J Korean Med Sci. 2018 Jun 26;33(32):e212. doi: 10.3346/jkms.2018.33.e212. 
      eCollection 2018 Aug 6.