PMID- 34349976
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220425
IS  - 2042-0986 (Print)
IS  - 2042-0994 (Electronic)
IS  - 2042-0986 (Linking)
VI  - 12
DP  - 2021
TI  - The safety of ceftolozane-tazobactam for the treatment of acute bacterial 
      infections: a systemic review and meta-analysis.
PG  - 20420986211027096
LID - 10.1177/20420986211027096 [doi]
LID - 20420986211027096
AB  - OBJECTIVES: The aim of this study was to conduct a meta-analysis to assess the 
      clinical safety of ceftolozane-tazobactam for the treatment of acute bacterial 
      infections in adult patients. METHODS: The PubMed, Embase, and Cochrane databases 
      were searched from their inception until May 2020 for relevant randomized 
      controlled trials (RCTs). Only RCTs evaluating the risk of adverse events (AEs) 
      for ceftolozane-tazobactam and comparative treatments for acute bacterial 
      infections in adult patients were included. RESULTS: Overall, four RCTs including 
      a total of 2924 patients (1475 in the ceftolozane-tazobactam group and 1449 in 
      the control group) were included in the meta-analysis. The rate of 
      treatment-emergent AEs was 51.3% (748/1458) in the ceftolozane-tazobactam group, 
      which was comparable to the control group, 49.9% [714/1430; odd's ratio (OR), 
      1.06; 95% confidence interval (CI), 0.91-1.25; I (2) = 0%]. In addition, no 
      difference was observed between the ceftolozane-tazobactam and control groups in 
      terms of the risk of serious AEs (OR, 1.22; 95% CI, 0.93-1.61; I (2) = 15.5%) and 
      the risk of discontinuing the study drug due to AEs (OR, 0.85; 95% CI, 0.55-1.33; 
      I (2) = 0%). The rate of all-cause mortality did not significantly differ between 
      the ceftolozane-tazobactam and control groups (OR, 1.11; 95% CI, 0.82-1.50; I 
      (2) = 0%). The only exception was the risk of Clostridiodes difficile (C. 
      difficile) colitis, where ceftolozane-tazobactam treatment was associated with a 
      significantly higher risk compared with the control group [0.72% (10/1376) versus 
      0.14% (2/1391), OR, 3.84; 95% CI, 1.23-11.97; I (2) = 0%]. CONCLUSION: 
      Ceftolozane-tazobactam treatment is as tolerable as comparative treatment options 
      for acute bacterial infections in adult patients, however it has an increased 
      risk of C. difficile infection. As a novel broad-spectrum antibiotic, 
      ceftolozane-tazobactam could be a safe therapeutic option for use in common 
      clinical practice. PLAIN LANGUAGE SUMMARY: The safety of ceftolozane-tazobactam 
      (an antibiotics) for the treatment of acute bacterial infections Objective(s): 
      Ceftolozane-tazobactam is an effective antibiotic for the treatment of acute 
      bacterial infections. This study conducts a meta-analysis to assess the clinical 
      safety (side effects) of ceftolozane-tazobactam for the treatment of acute 
      bacterial infections in adult patients compared with other drugs. Methods: We 
      extracted data from four randomized controlled trials, including a total of 2924 
      patients (1475 in the ceftolozane-tazobactam group and 1449 in the control 
      group). Results: The rate of treatment related adverse events (AEs) was similar 
      in the ceftolozane-tazobactam group (51.3%) and control group (49.9%). There was 
      also no difference in risk of serious adverse events, the risk of discontinuing 
      the study drug due to AEs, and all-cause mortality. The only exception was the 
      risk of Clostridiodes difficile colitis (a cause of antibiotic-associated 
      diarrhea), where ceftolozane-tazobactam treatment was associated with a 
      significantly higher risk compared with the control group. Conclusion: In 
      conclusion, as a novel broad-spectrum antibiotic, ceftolozane-tazobactam could be 
      a safe therapeutic option for use in clinical practice.
CI  - (c) The Author(s), 2021.
FAU - Wang, Li-Ting
AU  - Wang LT
AD  - Department of Internal Medicine, Chi-Mei Hospital, Chiali, Tainan.
FAU - Lin, Wei-Ting
AU  - Lin WT
AD  - Department of Orthopedic, Chi Mei Medical Center, Tainan.
FAU - Lai, Chih-Cheng
AU  - Lai CC
AD  - Department of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan 
      Branch, Tainan.
FAU - Wang, Ya-Hui
AU  - Wang YH
AD  - Medical Research Center, Cardinal Tien Hospital and School of Medicine, College 
      of Medicine, Fu Jen Catholic University, New Taipei City.
FAU - Chen, Cheng-Hsin
AU  - Chen CH
AD  - Department of Internal Medicine, Cardinal Tien Hospital and School of Medicine, 
      College of Medicine, Fu Jen Catholic University, New Taipei City.
FAU - Chang, Yen-Teh
AU  - Chang YT
AD  - Department of Internal Medicine, Cardinal Tien Hospital, No.362, Zhongzheng Road, 
      Xindian Dist., New Taipei City, 231.
FAU - Chen, Chao-Hsien
AU  - Chen CH
AUID- ORCID: 0000-0002-2176-3504
AD  - Division of Pulmonary, Department of Internal Medicine, MacKay Memorial Hospital, 
      No. 45, Minsheng Rd., Tamsui District, New Taipei City 251.
FAU - Wang, Cheng-Yi
AU  - Wang CY
AD  - Department of Internal Medicine, Cardinal Tien Hospital, No.362, Zhongzheng Road, 
      Xindian Dist., New Taipei City, 231.
LA  - eng
PT  - Journal Article
DEP - 20210715
PL  - England
TA  - Ther Adv Drug Saf
JT  - Therapeutic advances in drug safety
JID - 101549074
PMC - PMC8290504
OTO - NOTNLM
OT  - acute bacterial infection
OT  - adverse event
OT  - ceftolozane-tazobactam
OT  - safety
COIS- Conflict of interest statement: The authors declare that there is no conflict of 
      interest.
EDAT- 2021/08/06 06:00
MHDA- 2021/08/06 06:01
PMCR- 2021/07/15
CRDT- 2021/08/05 06:27
PHST- 2021/03/21 00:00 [received]
PHST- 2021/06/03 00:00 [accepted]
PHST- 2021/08/05 06:27 [entrez]
PHST- 2021/08/06 06:00 [pubmed]
PHST- 2021/08/06 06:01 [medline]
PHST- 2021/07/15 00:00 [pmc-release]
AID - 10.1177_20420986211027096 [pii]
AID - 10.1177/20420986211027096 [doi]
PST - epublish
SO  - Ther Adv Drug Saf. 2021 Jul 15;12:20420986211027096. doi: 
      10.1177/20420986211027096. eCollection 2021.