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Positive phase IV results for Zyvox

Pfizer has announced positive results of a phase IV study of its antibiotic Zyvox (linezolid) as a treatment for MRSA

Pfizer has announced positive results of an international phase IV study of its antibiotic Zyvox (linezolid) as a treatment for nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA).

Data from the study showed that Zyvox achieved a statistically significantly higher clinical success rate compared with vancomycin, which was first marketed as vancomycin hydrochloride by Eli Lily under the trade name of Vancocin, for the primary endpoint.

The study consisted of 1,225 patients across 156 centres around the world. Of these participants, 448 patients had proven MRSA nosocomial pneumonia, while 339 patients also met key protocol criteria at the end of the study meaning they were included in the primary analysis.

Patients treated with Zyvox showed a clinical success rate of 57.6 per cent compared with a success rate of 46.6 per cent for patients treated with vancomycin. 

"Nosocomial pneumonia continues to be a significant cause of illness, and when these infections are due to MRSA, our options are limited, as there are few antibiotics that are effective against this resistant organism," said study investigator Dr Jean Chastre, professor of medicine and critical care medicine, University Paris 6, Reanimation Medicale, Pitie-Salpetriere Hospital, Paris.  

"The findings, which show a higher cure rate for linezolid [Zyvox] compared with vancomycin, provide important information for physicians who treat nosocomial pneumonia caused by MRSA," Dr Chastre continued.

Safety data from the international trial showed that treatment-related adverse events, serious adverse events and deaths were comparable for Zyvox and vancomycin. Overall, 16.2 per cent of Zyvox patients and 18.4 per cent of vancomycin patients experienced adverse events that were considered to be treatment-related.

"Pfizer is committed to research in infectious diseases, and data from this large comparative study add to the body of evidence for Zyvox in the treatment of MRSA nosocomial pneumonia and reinforce its efficacy in this patient population," said Dr Mark Kunkel, executive director, clinical group lead for anti-infective drugs, specialty care business unit, Pfizer.

21st October 2010

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