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Antibiotic Also Proves Effective in Treating Multi-Drug Resistant Pneumonia Strains
WASHINGTON, DC, November 1, 2004 - A new study showed that hospitalized patients with community-acquired pneumonia (CAP) who received sequential therapy with the I.V. and oral forms of the antibiotic Aveloxâ (moxifloxacin HCI/in NaCI injection) experienced faster symptom relief (3.8 days) than patients treated with the I.V. form of another antibiotic, ceftriaxone, with or without erythromycin for 4.8 days. The study also showed reduced length of hospital stays in CAP patients who were prescribed Avelox vs. comparators. Both regimens were generally well tolerated.
The study, known as MOXIRAPID, was presented today at the 44th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
CAP affects 4.5 million adults in the U.S. annually, resulting in 10 million physician visits, 500,000 hospitalizations and 45,000 deaths each year.
“Switching to oral antibiotic therapy once CAP patients were clinically stable lessened their time in the hospital,” said Dr. Michael Niederman, Winthrop University Hospital, Mineola, NY. “Using an antibiotic such as Avelox that has demonstrated excellent clinical success and safety may benefit CAP patients not only in the hospital setting, but in the community as well.”
Another study, a retrospective analysis also presented at ICAAC, found Avelox effective in treating CAP due to multi-drug resistant Streptococcus pneumoniae (MDRSP). Since the majority of CAP cases are caused by S. pneumoniae, the rising incidence of this bacteria becoming resistant to antibiotics is a growing concern within the medical community.
In the study, Avelox demonstrated 95 percent clinical and bacteriological success against strains resistant to two or more commonly used antibiotics, including macrolides such as clarithromycin and azithromycin; penicillin; second-generation cepholosporins such as cefuroxime; trimethroprim-sulfamethoxazole; and tetracyclines.
The results of these two studies demonstrate that Avelox is an excellent treatment option for CAP,” said Dr. Niederman. “This antibiotic kills S. pneumoniae resistant to some other antibiotics and patients experienced faster symptom relief than comparators.”
About the MOXIRAPID Study
In the MOXIRAPID study, adult patients with bacterial CAP that required initial I.V. treatment were randomized to receive either Avelox I.V. (400 mg once daily), possibly followed by oral tablets, or ceftriaxone I.V. (2 g once daily) with or without erythromycin (I g I.V. every six hours or eight hours). Both treatment groups received their antibiotic for 7-14 days and clinical response was determined at the test-of-cure (TOC) visit, 5 to 20 days after ending therapy.
Clinical cure at TOC was achieved in 85.7 percent of Avelox patients and in 86.5 percent of ceftriaxone patients. While clinical efficacy was the same for both antibiotics, fevers subsided one day earlier in Avelox patients (3.8 days vs. 4.8 days). Overall treatment duration was significantly shorter for Avelox than ceftriaxone (5.4 days vs. 9.8 days), most likely as a result of the I.V. to oral tablet switch. Mean length of hospital stay was also much shorter for patients prescribed Avelox (9.8 days vs. 11.1 days for ceftriaxone patients). Both regimens were well tolerated.
About the MDRSP Study
The MDRSP analysis assessed the efficacy of Avelox in treating CAP caused by penicillin-, macrolide- and multi-drug resistant S. pneumoniae strains. MDRSP was defined as resistance to at least three antibiotics.
A pooled analysis of six prospective CAP trials was analyzed for susceptibility profiles and clinical and bacteriologic outcomes of patients with confirmed S. pneumoniae infections. For all patients with a pre-therapy S. pneumoniae isolate, clinical cure rate was seen in 95 percent of patients treated with Avelox. For penicillin-resistant, macrolide-resistant and MDRSP strains, clinical cure and eradication at TOC was reported for 100 percent, 96 percent and 96 percent of Avelox-treated patients, respectively.
About Avelox
Avelox is approved to treat: 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 Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; 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 µg/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.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation www.bayerpharma.com is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG.
Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.
Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
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 Bayer’s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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