Acute Bacterial Sinusitis - New Study Data Confirm Excellent Speed Of Eradication By Avelox(R) (moxifloxacin HCl)

Main Category: Ear, Nose and Throat
Article Date: 29 May 2006 - 0:00 PDT

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A recently published study in the peer-reviewed online journal BMC Ear, Nose and Throat disorders found that Avelox(R) (moxifloxacin HCl) eradicated all pathogens in patients suffering from acute bacterial sinusitis (ABS) within only three days.

The purpose of the study was to specifically investigate in the real world setting of a doctor's office, how quickly bacteria are eradicated from the sinuses through antibiotic treatment with moxifloxacin. Knowing how long it takes to remove the cause of infection makes it easier to evaluate the potential of antibiotic treatments to relieve the symptoms of sinusitis.

"Acute bacterial sinusitis is a painful disease typically characterized by facial pain or pressure, so when treating patients it's very important to help them get better quickly." said Dr. Horatio Ariza, lead study author and Head of the Department of Infectious disease at Hospital Zonal General de Agudos "Mi Pueblo", Buenos Aires, Argentina. "This study clearly found that moxifloxacin is a fast and effective treatment offering rapid symptom relief to sinusitis patients."

ABS is caused by bacteria which multiply and invade the sinuses when the body's defenses weaken or sinus drainage is blocked by a viral infection like the common cold. Symptoms of ABS can be identical to those of a viral infection, although ABS is usually more severe and can last up to 30 days.

In the United Kingdom alone, six million restricted working days are estimated to be a result of acute sinusitis every year. In the United States, there are an estimated 20 million cases of ABS per year. The number of missed worked days due to sinusitis in the USA has reached 12.5 million while that of restricted activity days is 58.7 million.

"By getting ABS patients back on their feet quickly has positive effects not only for them but also for society in terms of the millions of lost days of productivity," added Dr. Ariza.

About The Study

In this prospective open-label study, a total of 192 patients diagnosed with ABS were enrolled. Of these, 42 could be evaluated based on 48 forms of bacteria identified during screening. They received 400 mg of Avelox(R) once daily for 10 days. The screening process included using nasal endoscopy to obtain secretion samples to determine bacterial infection. The sampling procedure was repeated for three consecutive days after treatment started to determine bacterial eradication and persistence. The patients received Avelox treatment on the first day. By the second day, 83.3% of the types of bacteria were eradicated. On the third day, all types of bacteria were eliminated.

About Avelox

In Europe , Avelox(R) IV (+ oral sequential therapy) is approved to treat Community Acquired Pneumonia (CAP), and Complicated Skin and Skin Structure Infections (cSSSI). Avelox(R) 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, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology; Oncology and Primary Care. 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.

Forward-looking statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development, or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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