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Positive Study for Bayer's Avelox

Posted on: Wednesday, 26 July 2006, 12:00 CDT

A study involving 681 patients has shown that Bayer and Schering-Plough's antibiotic Avelox was as effective and well tolerated, when taken as monotherapy, as a standard multi-dose combination antibiotic regimen for the treatment of complicated intra-abdominal infections.

Avelox was developed by Bayer and is marketed in the US by Schering-Plough. The drug, the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat complicated intra-abdominal infections (cIAI), was shown to be effective at eradicating the most common bacteria that cause such infections, including E. coli and B. fragilis.

In the study, patients who took 400mg once daily of Avelox intravenous (IV) followed by oral monotherapy achieved similar clinical cure rates (80%) at the test-of-cure visit (the primary efficacy endpoint) as patients who took a standard regimen of IV piperacillin-tazobactam followed by oral amoxicillin-clavulanate (78%).

Importantly, Avelox demonstrated a significantly higher cure rate of 82% - compared to 55% for the combination therapy - among patients who acquired their cIAI in a hospital setting (including both mild- to-moderate and more severe hospital-acquired infections). Hospital-acquired infections are often caused by more resistant bacteria than community-acquired infections.

Clinical cure rates for patients with community-acquired infections were similar between the two treatment groups.

Results from the study were published in the current issue of the Annals of Surgery.

Source: Datamonitor

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