Tigecycline: in community-acquired pneumonia
Kate McKeage1, Gillian M Keating
1Wolters Kluwer Health, Adis, Auckland, New Zealand. demail@adis.co.nz
Abstract:
Tigecycline is a first-in-class glycylcycline, broad-spectrum, intravenous antibacterial developed to overcome the two major mechanisms of tetracycline resistance (ribosomal protection and efflux). The drug has been in use since 2005 for complicated intra-abdominal infections, and complicated skin and soft tissue structure infections, but is currently being assessed in the US for community-acquired pneumonia (CAP) in adults. In vitro, tigecycline had good activity against a range of Gram-positive, Gram-negative and atypical community-acquired respiratory tract pathogens implicated in CAP. Compared with other antibacterials, tigecycline has a prolonged post-antibiotic effect against key bacteria and a long serum elimination half-life in humans. The drug effectively penetrates lung tissue. The combined results of two well designed, phase III studies demonstrated that tigecycline 100 mg initially, followed by 50 mg every 12 hours for 7-14 days was not inferior to recommended dosages of levofloxacin in the treatment of hospitalized patients with CAP. Clinical cure rates were 89.7% versus 86.3% in the clinically evaluable population and 81.0% versus 79.7% in the clinical modified intent-to-treat population. Tigecycline was generally well tolerated in patients with CAP.
Insights
Tigecycline, an antibacterial, is effective for community-acquired pneumonia (CAP) in adults. Clinical trials show it is not inferior to levofloxacin, offering a new treatment option for CAP.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Microbiology
Background:
- Tigecycline is a first-in-class glycylcycline antibiotic designed to overcome tetracycline resistance mechanisms.
- Currently approved for complicated intra-abdominal and skin infections, its efficacy for community-acquired pneumonia (CAP) in adults is under evaluation.
- Tigecycline exhibits broad-spectrum activity against common respiratory pathogens and possesses favorable pharmacokinetic properties, including a prolonged post-antibiotic effect and lung tissue penetration.
Purpose of the Study:
- To assess the efficacy and tolerability of tigecycline in the treatment of hospitalized adult patients with community-acquired pneumonia (CAP).
Main Methods:
- Two well-designed Phase III clinical studies were conducted.
- Hospitalized adult patients with CAP were treated with tigecycline (100 mg initially, then 50 mg every 12 hours for 7-14 days) or levofloxacin.
- Efficacy was evaluated based on clinical cure rates in clinically evaluable and modified intent-to-treat populations.
Main Results:
- Tigecycline demonstrated non-inferiority to levofloxacin in treating CAP.
- Clinical cure rates for tigecycline were 89.7% (clinically evaluable) and 81.0% (modified intent-to-treat).
- Tigecycline was generally well tolerated by patients with CAP.
Conclusions:
- Tigecycline is a safe and effective treatment option for hospitalized adult patients with community-acquired pneumonia.
- The drug's efficacy and tolerability profile support its use as an alternative to levofloxacin for CAP.
- Tigecycline's activity against resistant pathogens makes it a valuable addition to the treatment armamentarium for respiratory tract infections.
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