Schering-Plough Corporation (NYSE: SGP) today reported that monotherapy with the once-daily, broad-spectrum antibiotic AVELOX (moxifloxacin HCl) was as effective and well tolerated as a standard multi-dose combination antibiotic regimen in the treatment of patients with complicated intra-abdominal infections (cIAI), according to results of a study involving 681 patients published in the current issue of the Annals of Surgery.(1) AVELOX, the only marketed fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) as monotherapy to treat cIAI, was shown to be effective at eradicating the most common bacteria that cause cIAI, including E. coli and B. fragilis.
In the study, patients who took 400 mg once daily of AVELOX intravenous (I.V.) followed by oral monotherapy achieved similar clinical cure rates (80 percent) at the test-of-cure visit (the primary efficacy endpoint) as patients who took a standard regimen of I.V. piperacillin-tazobactam followed by oral amoxicillin-clavulanate (78 percent).
Importantly, AVELOX demonstrated a significantly higher cure rate of 82 percent compared to 55 percent 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.
The incidence of adverse events in the study due to any cause was similar for the two treatment groups, with the majority being mild or moderate in nature. The most common adverse events were nausea, hypokalemia, abdominal pain and constipation. The incidence of drug-related serious adverse events or premature discontinuation due to adverse events was similar for the two treatment groups.
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