Clinical Guidelines for Treatment of LRTI Should Take Account of New Clinical Data

COPENHAGEN, DENMARK, September 20, 2005 - A panel of distinguished academic physicians from Canada, Europe and the United States today discussed current treatment strategies for lower respiratory tract infections (LRTI) at a symposium held in conjunction with the 15th Annual Congress of the European Respiratory Society (ERS) in Copenhagen, Denmark. They concluded that new clinical data means it is now necessary to revisit some of the prescribing recommendations set out in current LRTI treatment guidelines and consider the earlier use of more potent antibiotics.

The panel examined different strategies for the treatment of acute exacerbations of chronic bronchitis (AECB) and community acquired pneumonia (CAP), reviewed the existing treatment guidelines for these infections and also summarised new data from recent clinical trials of moxifloxacin (Avelox®), Bayer's respiratory fluoroquinolone antibiotic for the treatment of respiratory tract infections.

"Not all antibiotics are the same," said the chairman, Dr. Ronald F. Grossman, (Professor of Medicine at the University of Toronto, Canada), "but so far, because of the requirements of the regulatory authorities, very few clinical trials of antibiotics have actually been designed to show the benefits of one treatment over another. However, new trials are now emerging with novel endpoints, such as infection-free interval and pharmaco-economic outcomes, and these studies do reveal distinct advantages for certain antibiotics."

Dr. Meyer Balter, (Associate Professor of Medicine at the University of Toronto, Canada), presented data from the MOSAIC study and stated, "These data clearly show the superiority of moxifloxacin not only in terms of short-term clinical cure but also the long-term outcome of delaying the time to the next clinical exacerbation, the latter significantly improving patients' quality of life". The MOSAIC study compared moxifloxacin to standard (non-fluoroquinolone) antibiotics in the treatment of AECB.

Panel member Dr. Antonio Anzueto, (Professor of Medicine at the University of Texas Health Science Center, Texas, USA) discussed results from the CAPRIE study. "Moxifloxacin achieved a cure rate of more than 90 percent in all population sub-groups in the study." said Dr. Anzueto, "The safety profile was shown to be comparable to levofloxacin and clinical success was achieved significantly faster in the moxifloxacin arm. This, together with a previous study, TARGET, which showed the superiority of moxifloxacin monotherapy compared with standard combination therapy, means that it is an excellent treatment option for CAP". CAPRIE was the first a head-to-head trial of moxifloxacin versus levofloxacin in the treatment of CAP and the first to be carriedoutspecificallyinelderlypatients(>65yrs).

The final session of the symposium discussed the development of outcome-based guidelines in CAP and AECB. Dr. Antoni Torres, (Associate Professor of Pulmonology at the Faculty of Medicine of the University of Barcelona, Spain) addressed the need for updating the assessment of first and second-line therapies in AECB and CAP treatment: "To achieve optimal clinical outcomes in CAP and AECB it is increasingly accepted that the first-line antimicrobial agent should be the most potent available that is clinically effective, that eradicates the bacterial pathogens and provides coverage of resistant strains. Excellent outcome data in both AECB and CAP are available with respiratory fluoroquinolones like moxifloxacin which indicates that it is now necessary to revisit some of the prescribing recommendations set out in current guidelines - a step that is currently being taken by some of the key societies."

The symposium, "Antibiotic Therapy: Short- and Long-Term Outcomes in LRTI" was held from 1715h to 1915h on Monday, 19 September, in Auditorium 12 of Bella Center in Copenhagen, Denmark and was supported by an educational grant from Bayer HealthCare.

Full Speaker credentials:

• Dr. Ronald F. Grossman is Professor of Medicine at the University of Toronto and Chief of Medicine at Credit Valley Hospital (Mississauga) in Ontario, Canada
• Meyer Balter, MD FRCPC, Associate Professor of Medicine at the University of Toronto and Director of the Asthma Education at Mount Sinai Hospital, Toronto, Ontario, Canada and Internal Medicine Residency Training Program Director at Mount Sinai Hospital
• Dr. Antonio Anzueto, Professor of Medicine at the University of Texas Health Science Center and Chief of the Pulmonary Section for the South Texas Veterans Health Care System, in San Antonio, Texas
• Dr. Antoni Torres, Associate Professor of Pulmonology at the Faculty of Medicine of the University of Barcelona, Chief of the Pulmonary Department and Senior Consultant at the Hospital Clinic in Barcelona, Spain

About Avelox
In Europe, Avelox® IV (+ oral sequential therapy) is approved to treat Community Acquired Pneumonia (CAP), and Complicated Skin and Skin Structure Infections (cSSSI). Avelox® Oral is approved to treat Community Acquired Pneumonia (CAP) - except severe cases, Acute Bacterial Sinusitis (ABS) where adequately diagnosed, and Acute Exacerbations of Chronic Bronchitis (AECB).

About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.

Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.

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