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Expert Rev Clin Pharmacol. 2012 Sep;5(5):509-12. doi: 10.1586/ecp.12.50.

Early response of ceftaroline fosamic in the treatment of soft-tissue infections.

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1
Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Science, Wayne State University, St John Hospital and Medical Center, Detroit, MI 48201, USA.

Abstract

The US FDA recently approved ceftaroline tosamil (ceftaroline) for the treatment of acute bacterial skin and soft structure infections (ABSSSIs) and community-acquired pneumonia. In 2010, the FDA specified a new primary end point for ABSSSI of 3 days instead of the traditional test of cure. Friedland et al. used the new FDA end point in evaluating the CANVAS 1 and 2 trials. In the exploratory modified, intention-to-treat analysis, ceftaroline showed a superior clinical response at day 3 (74 vs 66.2%; difference 7.7%; 95% CI: 1.3-14%). The superior response of ceftaroline has biologic plausibility based on the in vitro activity of the antibiotic, suggesting that a true early clinical benefit may exist. However, owing to the potential for selection bias and lack of logistic regression analysis, caution should be used when extrapolating these results to clinical practice. Future trials utilizing this new end point in prospective ABSSSI trials will show over time the true value of such an end point.

PMID:
23121271
DOI:
10.1586/ecp.12.50
[Indexed for MEDLINE]

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