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Avelox (moxifloxacin HCl) Appears More Effective Than Commonly Prescribed Antibiotics in Treating Chronic Bronchitis: Presented at ATS

ORLANDO, FL -- May 26, 2004 -- Chronic obstructive pulmonary disease (COPD)* patients with acute exacerbations of chronic bronchitis (AECB) who took the antibiotic Avelox* (moxifloxacin HCl) for five days experienced significantly faster recovery compared to patients who took Biaxin* (clarithromycin) or Augmentin* (amoxicillin/clavulanate) for 10 days. This was the principal finding of a study presented today at the 100th International Conference of the American Thoracic Society (ATS).

The study, conducted in the offices of primary care physicians, found that 70% of patients who took Avelox saw their symptoms resolve within five days or less compared to patients who took Biaxin (50%) or Augmentin (44%), two of the antibiotics commonly prescribed to treat these exacerbations, for 10 days.

Speed of symptom relief is the primary concern for people who suffer from exacerbations of chronic bronchitis. A recent international survey of more than 1,100 chronic bronchitis patients found that more than half (55%) identified faster symptom relief as their primary treatment need. More than half of patients reported that their AECB symptoms forced them to give up enjoyable activities or disrupted their sleep.

"This study shows that Avelox is associated with a more rapid remission of symptoms compared with some commonly used antibiotics. This is consistent with previous studies. Avelox has also been shown to have excellent bacterial eradication rates," said Dr. Marc Miravitlles, lead study author, chest physician and senior researcher in the department of Pneumology at the Hospital Clinic, Barcelona, Spain. "The combination of these factors may be a great benefit for patients."

Many COPD patients have some element of chronic bronchitis, which is characterized by persistent cough, for a minimum of three months per year, for two consecutive years. AECB occurs when bacteria that are already in the bronchial tubes multiply and cause increased shortness of breath, mucus production, and coughing. Clinical experience has shown chronic bronchitis patients experience approximately three exacerbations per year, and that 50%-70% of these exacerbations are caused by bacterial infections. In fact,
respiratory tract infections (RTIs) such as bronchitis, sinusitis and pneumonia, are the most frequent cause of visits to physicians in the United States, compared to common conditions such as hypertension, gastrointestinal disorders and diabetes.

"Primary care physicians are on the front lines of treating RTIs, and our first priority is diagnosing patients properly and providing them with treatment that will allow them to feel better and resume normal activities, such as work, as quickly as possible," said Shari Fine, D.O., Assistant Clinical Professor, Department of Family Medicine, UMDNJ, Jersey City, NJ. "Since so many exacerbations are caused by bacteria, it is important for primary care physicians to know that an antibiotic such as Avelox, which is fast-acting and effective for symptom relief and bacterial eradication, is available for the appropriate RTI patients."


About Avelox

Avelox is approved to treat: *Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis,Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or
Chlamydia pneumoniae; Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; and uncomplicated Skin and Skin Structure Infections (uSSSI) caused by Staphylococcus aureus or Streptococcus pyogenes.

*MDRSP, Multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotic classes: penicillin (MIC ³ 2 mcg/mL), second generation cephalosporins, e.g. cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Important Safety Considerations

Avelox is a prescription medication that is generally well tolerated. The most common side effects, which are usually mild, include nausea, diarrhea and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness.

You should not take Avelox if you have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. You should avoid taking Avelox if you have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone and sotalol.

If you are pregnant or planning to become pregnant while taking Avelox, talk to your healthcare provider before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Avelox is not recommended for children under the age of 18 years.

Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. You should take Avelox either four hours before or eight hours after taking these products.

Be sure to inform your healthcare provider of any medical conditions you have and all prescription and non-prescription medications or supplements you are taking. If you have any concerns about your medication or side effects, please contact your healthcare provider.

For Avelox prescribing information and indicated organisms, log on to www.AveloxUSA.com or call Bayer Clinical Communications at 800-288-8371.



*Biaxin is a registered trademark of Abbott Laboratories
**Augmentin is a registered trademark of GlaxoSmithKline

References:

* International telephone survey, conducted by Psyma International Medical Marketing Research. Bayer AG sponsored this survey to assess patient conditions independently of physicians
* American Lung Association. Chronic Bronchitis: What is Chronic Bronchitis" Available at
<http://www.lungusa.org/site/pp.asp"c=dvLUK9O0E&b=35019>. Accessed May 4, 2004.
* American Lung Association. Chronic Bronchitis: What Causes Chronic Bronchitis" Available at
<http://www.lungusa.org/site/pp.asp"c=dvLUK9O0E&b=35019>. Accessed May 4, 2004.
* Niederman, M. The Role of Quionlones in the Treatment of Chronic Bronchitis. Infect Med 16(sA):5-7, 1999
* Miravitlles, M. Epidemiology of Chronic Obstructive Pulmonary Disease Exacerbations. Clin Pulm Med 2002; 9:191-7.
* National Disease Therapeutic Index (IMS America, Ltd.)

SOURCE: GCI Group

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