PMID- 33483853
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210329
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 10
IP  - 1
DP  - 2021 Mar
TI  - Comparison of Prospective and Retrospective Methods of a Tigecycline 
      Post-Marketing Surveillance Study in the Safety Outcomes of Patients with 
      Complicated Skin Structure Infection, Complicated Intraabdominal Infection and 
      Community-Acquired Pneumonia.
PG  - 411-420
LID - 10.1007/s40121-021-00398-7 [doi]
AB  - INTRODUCTION: Safety data can be collected through prospective and retrospective 
      methods during post-marketing surveillance (PMS). This study aimed to compare 
      prospective and retrospective methods in terms of examining safety data from PMS 
      of tigecycline. METHODS: This PMS study was an open-label, noncomparative, 
      observational, noninterventional and multicenter study of patients who received 
      tigecycline for infections. From July 2007 to April 2015, 3172 patients were 
      included in this study, of which 738 were enrolled prospectively and 2434 
      retrospectively. To reduce selection bias, demographic and baseline 
      characteristics were adjusted using 1:2 propensity score matching. RESULTS: After 
      propensity score matching, data from 1446 patients were analyzed. The incidences 
      of adverse events (AEs) and serious AEs (SAEs) were determined to be 
      significantly higher in the prospective method compared with those of the 
      retrospective method (P < 0.001 and P = 0.004, respectively). However, no 
      significant differences in the incidences of adverse drug reactions (ADRs) and 
      serious ADRs (SADRs) were detected between the two groups (P = 0.09 and P = 0.33, 
      respectively). In a subgroup analysis of 360 patients from 14 hospitals involved 
      in both prospective and retrospective methods, the incidence of AEs was found to 
      be significantly higher using the prospective method compared with when the 
      retrospective method was used (P < 0.001), but there were no significant 
      differences in ADRs (P = 0.14), SAEs (P = 0.24) and SADRs. CONCLUSION: In 
      general, the prospective method can detect safety data effectively in a PMS 
      study, whereas retrospective data collection may be an alternative option in 
      collecting ADR data when a prospective PMS study is not deemed feasible.
FAU - Chi, Whanhui
AU  - Chi W
AD  - Pfizer Inc, Seoul, Republic of Korea.
FAU - Lee, Hye Jung
AU  - Lee HJ
AD  - Pfizer Inc, Seoul, Republic of Korea.
FAU - Chong, Yong Pil
AU  - Chong YP
AUID- ORCID: 0000-0003-1672-3185
AD  - Department of Infectious Diseases, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Republic of Korea. drchong@amc.seoul.kr.
LA  - eng
PT  - Journal Article
DEP - 20210122
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC7955005
OTO - NOTNLM
OT  - Community-acquired pneumonia
OT  - Complicated intraabdominal infection
OT  - Complicated skin structure infection
OT  - Post-marketing surveillance
OT  - Prospective study
OT  - Retrospective study
OT  - Safety
OT  - Tigecycline
EDAT- 2021/01/24 06:00
MHDA- 2021/01/24 06:01
PMCR- 2021/01/22
CRDT- 2021/01/23 05:40
PHST- 2020/12/02 00:00 [received]
PHST- 2021/01/06 00:00 [accepted]
PHST- 2021/01/24 06:00 [pubmed]
PHST- 2021/01/24 06:01 [medline]
PHST- 2021/01/23 05:40 [entrez]
PHST- 2021/01/22 00:00 [pmc-release]
AID - 10.1007/s40121-021-00398-7 [pii]
AID - 398 [pii]
AID - 10.1007/s40121-021-00398-7 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2021 Mar;10(1):411-420. doi: 10.1007/s40121-021-00398-7. Epub 
      2021 Jan 22.