Best Evidence Analyses and Commentary
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Tigecycline is FDA approved in patients 18 years of age or older for the treatment of complicated skin and skin structure infections (SSSI) caused by susceptible organisms, including methicillin-resistant Staphylococcus aureus and vancomycin sensitive Enterococcus faecalis. In addition, it is indicated for the treatment of complicated intra-abdominal infections (cIAI) and community-acquired pneumonia (CAP) caused by susceptible organisms.1

To date, tigecycline does not have a place in therapy for hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) due to an increase in mortality that was observed when using tigecycline in these conditions. A search of the medical literature returned several supportive studies.

Freire, et al. (2010) conducted a phase 3, randomized, double-blind trial comparing tigecycline with imipenem/cilastatin for the treatment of HAP.2 Patients were given an initial dose of 100 mg IV, followed by 50 mg IV every 12 hours. The tigecycline regimen was non-inferior to the imipenem/cilastatin group for non-VAP, but did not meet the statistical criteria of non-inferiority to the imipenem/cilastatin regimen in the VAP group.2, 3 While it remains unclear why VAP patients treated with tigecycline had lower cure rates, one hypothesis is the lower AUC/MIC that was observed.2 The traditional dose of tigecycline attained very low serum concentrations (0.655 mcg/mL in the steady state), raising some concerns regarding the use of this drug for the treatment of infections with secondary bacteremia.3

Gandjini, et al. (2012) also compared tigecycline to imipenem/cilastatin in HAP. This phase 2, multicenter, double-blind study compared higher doses of tigecycline. Patients received either tigecycline 75 mg IV every 12 hours, tigecycline 100 mg IV every 12 hours or an imipenem/cilastatin regimen. The authors noted improved efficacy in the patients who received the tigecycline 100 mg regimen; however, the sample size was too small to reach statistical significance. Due to enrollment challenges, this study was discontinued prior to planned full enrollment.4

The American Thoracic Society recommends the following regimen (Table 1) for treatment of early onset (within 4 days of hospitalization) HAP and VAP.5

The American Thoracic Society recommends the following regimen (Table 2) for late onset (> 5 days) HAP AND VAP.5

Based on the information about tigecycline and the current data from clinical trials, tigecycline should not be recommended for the treatment of HAP or VAP. There is a documented increase in the risk of mortality when using standard doses of tigecycline to treat HAP or VAP, as well as insufficient data to support higher tigecycline doses in these patients. More literature is needed to better assess tigecycline’s role in the treatment of nosocomial pneumonias and whether or not a dosage increase is warranted.

References

  1. Tygacil [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc; 2012.
  2. Freire AT, Melnyk V, Kim MJ, et al. Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired pneumonia. Diagnostic Microbiology and Infectious Disease 2010; 68(2): 140-151.
  3. Bassetti M, Giacobbe DR, Taramasso L. Tigecycline Use in Hospital and its Potential Role in Infection Control. European Infectious Disease 2012; 6(1): 57-60.
  4. Gandjini H, McGovern PC, Yan JL, et al. Clinical efficacy of two high tigecycline dosage regimens vs. imipenem/cilastatin in hospital-acquired pneumonia: results of a randomized phase II clinical trial (abstract). Clinical Microbiology and Infectious Diseases 2012;18(suppl s3):64. Abstract O405.
  5. Guidelines for the Management of Adults with Hospital-acquired, Ventilator-associated, and Healthcare-associated Pneumonia. American Journal of Respiratory and Critical Care Medicine 2005; 171: 388-416.

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