Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies

J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140.

Abstract

Objectives: There is limited information on the use of tigecycline in real-life clinical practice. This analysis aims to identify and understand tigecycline prescribing patterns and associated patient outcomes for approved indications.

Patients and methods: A pooled analysis of patient-level data collected on the prescription of tigecycline in five European observational studies (July 2006 to October 2011) was conducted.

Results: A total of 1782 patients who received tigecycline were included in the analysis. Of these patients, 61.6% were male, the mean age was 63.4 ± 14.7 years, 56.4% were in intensive care units, 80.2% received previous antibiotic treatment and 91% had one or more comorbid conditions. The mean Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores at the beginning of treatment were 17.7 ± 7.9 and 7.0 ± 4.0, respectively. The majority of patients (58.3%) received tigecycline for treatment of complicated skin and soft-tissue infections (cSSTIs; n = 254) or complicated intra-abdominal infections (cIAIs; n = 785). Tigecycline was given at the standard dose (100 mg plus 50 mg twice daily) to 89.3% of patients for a mean duration of 11.1 ± 6.4 days. The main reasons for prescribing tigecycline were failure of previous therapy (46.1%), broad-spectrum antibiotic coverage (41.4%) and suspicion of a resistant pathogen (39.3%). Tigecycline was prescribed first-line in 36.3% of patients and as monotherapy in 50.4%. Clinical response rates to treatment with tigecycline alone or in combination were 79.6% (183/230; cSSTIs) and 77.4% (567/733; cIAIs).

Conclusions: Although tigecycline prescription behaviour showed some heterogeneity across the study sites, these results confirm a role for tigecycline in real-life clinical practice for the treatment of complicated infections, including those in critically ill patients, across Europe.

Trial registration: ClinicalTrials.gov NCT00488488 NCT00799591 NCT00827541.

Keywords: antibacterial prescribing practices; broad-spectrum antibacterial therapy; complicated intra-abdominal infections; complicated skin and soft-tissue infections; non-interventional studies.

Publication types

  • Meta-Analysis
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / therapeutic use*
  • Bacterial Infections / drug therapy*
  • Drug Prescriptions / statistics & numerical data*
  • Europe
  • Female
  • Humans
  • Intraabdominal Infections / drug therapy
  • Male
  • Middle Aged
  • Minocycline / analogs & derivatives*
  • Minocycline / therapeutic use
  • Skin Diseases, Bacterial / drug therapy
  • Soft Tissue Infections / drug therapy
  • Tigecycline
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Tigecycline
  • Minocycline

Associated data

  • ClinicalTrials.gov/NCT00488488
  • ClinicalTrials.gov/NCT00799591
  • ClinicalTrials.gov/NCT00827541