快樂小藥師 Im pharmacist nichts glücklich

Tigecycline Use Brings Risks

A meta-analysis confirms higher mortality with the drug.

ICU的同仁如果有用過老虎黴素，應該都隱隱約約的發現，使用這個藥的患者，雖然還是有不少案例獲得改善，多半都非死即傷，現在有研究告訴我們了。

The antibiotic tigecycline (Tygacil) was released in 2005 specifically to treat infections caused by resistant gram-positive organisms like methicillin-resistant staphylococci and vancomycin-resistant enterococci. However, some postmarketing data has suggested the drug is ineffective or even dangerous.

Researchers analyzed the results of 10 published and 3 unpublished trials that involved nearly 4000 patients who were randomized to receive tigecycline for various infections. Overall, short-term mortality was higher in tigecycline recipients than among those who received other antibiotics by about 30% (4% vs. 3%), and noncure rates were about 12% higher. These differences persisted in a variety of subanalyses adjusting for different infection types, subpopulations, approved versus nonapproved indications, and year of study.

Comment: The FDA released a warning in 2010 citing a similar mortality risk from tigecycline (JW Infect Dis Sep 8 2010). The authors of the present study argue against using the drug unless absolutely no effective alternatives are available. A thoughtful editorialist considers the increasingly complex arena of evaluating effective antimicrobial therapy and points out that even the assumption that tigecycline is better than nothing at all actually remains to be confirmed.

— Abigail Zuger, MD

Published in Journal Watch General Medicine July 10, 2012

CITATION(S):

Prasad P et al. Excess deaths associated with tigecycline after approval based on noninferiority trials. Clin Infect Dis 2012 Jun 15; 54:1699. [Free full-text Clin Infect Dis article PDF | Medline® abstract]

Powers JH. Asking the right questions: Morbidity, mortality, and measuring what's important in unbiased evaluations of antimicrobials. Clin Infect Dis 2012 Jun 15; 54:1710. [Free full-text Clin Infect Dis article PDF | Medline® abstract]

Copyright © 2012. Massachusetts Medical Society. All rights reserved.