Largest ever antibiotic study sheds new light on AECBs and confirms effective antibiotic therapy with Avelox^® can reduce the significant negative impact on patients’ quality of life

LEVERKUSEN, April 27, 2006 – Data analysis of GIANT, the Greatest International Antibiotic Trial, shows that almost as many women as men suffer from acute exacerbations of chronic bronchitis (AECBs). Traditionally, this condition has been typically regarded as more of a “male disease” rather than one associated with both sexes.

The GIANT study also showed that the quality of life of patients who experience an AECB is profoundly affected. AECB symptoms are often regarded as more of a nuisance with few serious consequences, but data from the study showed that actually, patients’ quality of life suffered surprisingly badly during the course of an exacerbation, not only during the day but also at night. According to patients, treatment with Avelox^® (moxifloxacin) reduced the impact of their symptoms on their daily activities as well as reducing sleep disturbance, confirming the treatment as highly effective as shown in previous rigorous clinical studies such as MOSAIC.

By end of March 2006, data from almost 34,000 patients had been collected and with more than 47,000 patients enrolled, GIANT is already the largest antibiotic study ever carried out. When it finishes in 2007, the study is expected to have enrolled 50,000 patients world-wide. It is the first global trial of its kind to evaluate the complete course of AECB progression and possible long-term benefits of antibiotic treatment over a one year follow-up period. It will also provide consistent, global knowledge on the epidemiology of chronic bronchitis as well as typical patient characteristics. In addition, many questions about physicians’ knowledge of the disease, the impact on patients and benefits of treatment with moxifloxacin on AECB should be answered.

“GIANT was initiated to learn more about AECB and its treatment and already we are discovering valuable information about the epidemiology of chronic bronchitis and typical patient characteristics.”, said Professor Antonio Anzueto, “The MOSAIC study recently showed that antibiotic therapy with moxifloxacin positively influences both short and long-term outcomes for the patient - particularly those patients over 65 or with more severe symptoms. With GIANT we can see if the beneficial effect seen in clinical trials is seen in real-life.”

Among the statistics to emerge from the GIANT study so far:

• Almost half of the AECB patients were female (43%). This is surprisingly high as the disease has been commonly seen as a predominantly male condition. A reason for this may be that in past decades, the rate of smoking among women has increased considerably compared with men.
• Mean age of AECB sufferers is 60 years
• 55.1% of enrolled patients were current smokers. While smoking is an important etiological factor, age over 45 should also be considered to be a major risk factor: half of the AECB patients were aged between 50 and 70 years.
• 90% of AECB patients suffer from at least one additional disease, and two thirds in two or more organ systems.
• In the past 12 months the average patient suffered 2 AECBs
• Spirometry is not routinely done by physicians with only a third of patients having a FEV1 measurement recorded by their doctor.
• 80% of patients received an antibiotic at their previous exacerbation suggesting that physicians consider AECB to be of bacterial origin and treat it accordingly
• The normal activities of patients were significantly affected during an exacerbation: the impact on their daily routine lasted approximately 7 days with 5 days of sleep disturbance.
• Treatment with moxifloxacin resulted in rapid health improvement in all severity groups (~65% at day 3, ~90 % at day 5).
• Patients themselves were highly satisfied (68.2%) or satisfied (29.3%), respectively, with their treatment and confirmed the faster action compared to their last antibiotic treatment of AECB.
• The attending physicians assessed the overall treatment efficacy and tolerability with “very good” or “good” in more than 95% of patients.

“These data show that when patients experience an AECB, not only is their daily routine massively disturbed but they usually suffer from significant sleep disturbances as well.” explained Dr Marc Miravitlles, “The sooner they get out of this acute state, the better - early and effective symptom relief is a primary goal in AECB therapy and treatment with moxifloxacin certainly appears to help patients achieve this.”

“While we are thrilled to have preliminary data available we are very much looking forward to seeing the whole AECB picture when the study is complete.” said Professor Anzueto, “We’ll be able to see if risk factors are the same all over the world, if patients differ with regard to co-morbidities depending on their country of origin or if people respond to moxifloxacin treatment similarly no matter where they live. Later this year a regional interim analysis of Europe and Asia will be available and shared with the public.” he added.

A full presentation of the data and commentary will be made by Professor A. Anzueto and Dr M. Miravitlles at a web-cast press conference to be held on Thursday, April 27, 2006 at 11:30 am CET (see details at the end of the release). The event is supported by an educational grant from Bayer HealthCare.

Full Speaker credentials:
- Antonio Anzueto, Professor of Medicine, University of Texas Health Sciences Center, San Antonio, Texas, USA
Section chief, Pulmonary/Critical care, South Texas Veterans Health Care System, San Antonio, Texas, USA
- Marc Miravitlles, Chest Physician and Senior Researcher in the Department of Pneumology, Hospital Clinic in Provincial, Barcelona, Spain.
- Kathrin Stauch, Project Manager Post-Marketing Surveillance (PMS) Europe & Overseas, Bayer HealthCare, Leverkusen, Germany

About GIANT
GIANT, which was initiated in February 2004, is the first global trial of its kind to evaluate the complete course of AECB progression in patients affected by this disease. The study is conducted in an outpatient setting and allows investigators to gather patient case reports and detailed patient descriptions, including AECB history, risk factors and concomitant disease and medication. The large patient population will allow special analyses of different subsets of patients.

Ongoing data analysis will provide information on epidemiological and demographic factors of patients, including comparisons between geographical regions, patients’ quality of life, physicians rationale on using antibiotics as well as the efficacy and safety of moxifloxacin.

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).

For Avelox prescribing information and indicated organisms, log on to www.avelox.com or email global.avelox@bayer.com.

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.

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