Pharmacokinetics-Pharmacodynamics of Tigecycline in Patients with Community-Acquired Pneumonia
Open accessAbstract
Exposure-response analyses for efficacy and safety were performed for tigecycline-treated patients suffering from community-acquired pneumonia. Data were collected from two randomized, controlled clinical trials in which patients were administered a 100-mg loading dose followed by 50 mg of tigecycline every 12 h. A categorical endpoint, success or failure, 7 to 23 days after the end of therapy (test of cure) and a continuous endpoint, time to fever resolution, were evaluated for exposure-response analyses for efficacy. Nausea/vomiting, diarrhea, headache, and changes in blood urea nitrogen concentration (BUN) and total bilirubin were evaluated for exposure-response analyses for safety. For efficacy, ratios of the free-drug area under the concentration-time curve at 24 h to the MIC of the pathogen ( f AUC 0-24 :MIC) of ≥12.8 were associated with a faster time to fever resolution; patients with lower drug exposures had a slower time to fever resolution ( P = 0.05). For safety, a multivariable logistic regression model demonstrated that a tigecycline AUC above a threshold of 6.87 mg · hr/liter ( P = 0.004) and female sex were predictive of the occurrence of nausea and/or vomiting ( P = 0.004). Although statistically significant, the linear relationship between tigecycline exposure and maximum change from baseline in total bilirubin is unlikely to be clinically significant.
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Some studies in critically ill patients have reported benefits of PK/PD-based dosing in terms of clinical cure.
“Some studies in critically ill patients have reported benefits in terms of clinical cure [237, 250–253].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [252]
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Tigecycline Population Pharmacokinetics in Patients with Community- or Hospital-Acquired Pneumonia
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Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021
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- Authors
- Rubino, C. M., Bhavnani, S. M., Forrest, A., Dukart, G., Dartois, N., Cooper, A., Korth-Bradley, J., & Ambrose, P. G.
- Affiliations
- Institute for Clinical Pharmacodynamics (United States) (US)
- Pfizer (United States) (US)
- Venue
- Antimicrobial Agents and Chemotherapy
- Publisher
- American Society for Microbiology
- Published
- 2012-01
- Volume
- 56
- Issue
- 1
- Pages
- 130-136
- ISSN
- 0066-4804 (ISSN-L)
- 1098-6596
- PMC
- PMC3256083
- OpenAlex
- W2107348015
- Cited by
- 54
- References
- 7
- Citations by year
- 2026: 5 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 2 · 2021: 5 · 2020: 7 · 2019: 2 · 2018: 4 · 2017: 7 · 2016: 5 · 2014: 2 · 2013: 7
- FWCI
- 2.11
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Antimicrobial Agents and Chemotherapy (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Health Sciences › Medicine › Epidemiology › Pneumonia and Respiratory Infections
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Medicine › Antibiotic Resistance in Bacteria
- Keywords
- tigecycline, community-acquired pneumonia, exposure-response relationship, pharmacokinetics, pharmacodynamics, nausea and vomiting, bilirubin, blood urea nitrogen, tetracycline
- MeSH terms
- Tigecycline, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Bilirubin, Blood Urea Nitrogen, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Microbial Sensitivity Tests, Middle Aged, Minocycline, Regression Analysis, Sex Factors, Streptococcus pneumoniae, United States, Treatment Outcome, Community-Acquired Infections, Pneumonia, Bacterial, Area Under Curve
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