PMID- 30065584
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220318
IS  - 1013-9087 (Print)
IS  - 2005-3894 (Electronic)
IS  - 1013-9087 (Linking)
VI  - 30
IP  - 4
DP  - 2018 Aug
TI  - An Open Label, Multi-Center, Non-Interventional Post-Marketing Surveillance to 
      Monitor the Safety and Efficacy of ALTARGO(R) (Retapamulin) Administered in Korean 
      Patients According to the Prescribing Information.
PG  - 441-450
LID - 10.5021/ad.2018.30.4.441 [doi]
AB  - BACKGROUND: With the approval of topical retapamulin ointment in 2011, it was 
      officially required to conduct a post-marketing surveillance (PMS) study to 
      obtain further data of its safety profile and effectiveness, in accordance with 
      the requirement of the Korean Ministry of Food and Drug Safety (MFDS). OBJECTIVE: 
      This study had prospectively designed to monitor safety and tolerability with the 
      effectiveness of topical retapamulin in clinical practices. METHODS: Open label, 
      multi-center, non-interventional observational study was done from May 2011 to 
      October 2015. All subjects had bacterial skin infections of locally approved 
      prescribing information accordingly. The study mainly focused on safety issues in 
      the local target population (3,612 eligible subjects). And, drug effectiveness 
      was also evaluated by physicians. RESULTS: The incidence of adverse events (AEs) 
      and adverse drug reactions (ADRs) were 2.53% and 0.97%, respectively. In terms of 
      the incidence of unexpected AEs and ADRs, 1.45% and 0.33%, and for the incidence 
      of serious AEs, 0.28%, whereas no serious ADRs reported. And, the effectiveness 
      of topical retapamulin rate was 96.1% (1,697 of total 1,765 subjects). 
      CONCLUSION: Topical retapamulin is to be well-tolerated and effective in patients 
      with bacterial skin infections of locally approved prescribing information.
FAU - Hong, Woosung
AU  - Hong W
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Lee, Yil-Seob
AU  - Lee YS
AD  - GlaxoSmithKline, Seoul, Korea.
FAU - Park, Chun-Wook
AU  - Park CW
AD  - Department of Dermatology, Kangnam Sacred Heart Hospital, Hallym University 
      College of Medicine, Seoul, Korea.
FAU - Yoon, Moon-Soo
AU  - Yoon MS
AD  - Department of Dermatology, CHA University School of Medicine, Pocheon, Korea.
FAU - Ro, Young Suck
AU  - Ro YS
AUID- ORCID: 0000-0002-6083-0351
AD  - Department of Dermatology, Hanyang University College of Medicine, Seoul, Korea.
LA  - eng
PT  - Journal Article
DEP - 20180628
PL  - Korea (South)
TA  - Ann Dermatol
JT  - Annals of dermatology
JID - 8916577
PMC - PMC6029962
OTO - NOTNLM
OT  - Anti-bacterial agents
OT  - Product surveillance
OT  - Skin diseases
OT  - infection
OT  - postmarketing
COIS- CONFLICTS OF INTEREST: Woosung Hong and Yil-Seob Lee are employees of 
      GlaxoSmithKline and own company shares, which had no influence on the present 
      work. The other authors have nothing to disclose. All listed authors meet the 
      criteria for authorship set forth by the International Committee for Medical 
      Journal Editors.
EDAT- 2018/08/02 06:00
MHDA- 2018/08/02 06:01
PMCR- 2018/08/01
CRDT- 2018/08/02 06:00
PHST- 2017/05/22 00:00 [received]
PHST- 2018/03/26 00:00 [revised]
PHST- 2018/03/30 00:00 [accepted]
PHST- 2018/08/02 06:00 [entrez]
PHST- 2018/08/02 06:00 [pubmed]
PHST- 2018/08/02 06:01 [medline]
PHST- 2018/08/01 00:00 [pmc-release]
AID - 10.5021/ad.2018.30.4.441 [doi]
PST - ppublish
SO  - Ann Dermatol. 2018 Aug;30(4):441-450. doi: 10.5021/ad.2018.30.4.441. Epub 2018 
      Jun 28.