SEATTLE, Oct. 27 /PRNewswire/ -- A new study showed the antibiotic Avelox(R) (moxifloxacin HCl) was highly successful and safe in elderly patients with community-acquired pneumonia (CAP) compared to the antibiotic Levaquin(R) (levofloxacin).
Following three to five days of sequential therapy, i.e. starting with 400 mg iv and switching to the oral form when indicated, 97.9 percent of Avelox patients showed improvement compared to 90 percent of Levaquin patients, treated with 500 mg, a statistically significant difference (95 percent CI; 3.1 percent, 14.1 percent). Overall cure rates were higher among Avelox patients at 14 to 21 days (92.2 percent vs. 87.9 percent Levaquin) (95 percent CI; -1.9 percent, 11.9 percent) and clinical failures were 33 percent less than in Levaquin patients.
The study, known as Community-Acquired Pneumonia Recovery in the Elderly, or CAPRIE, was presented today at CHEST 2004, the 70th annual international scientific assembly of the American College of Chest Physicians.
CAPRIE is one of few studies that have evaluated CAP treatment in elderly (65 years or older) and very elderly (75 years or older) patients, even though the elderly are 60 percent more likely to be affected by CAP than the general population.(1) Appropriate and timely antibiotic administration is critical for this patient population -- past studies have shown that administration of antibiotics within four hours of hospital admission were associated with decreased mortality and faster discharge in elderly patients.(2)
"The elderly pneumonia patient is a particularly challenging patient to treat, and the rapid action and effectiveness that Avelox has shown in treating this population is promising. The results from this study suggest that Avelox continues to be an excellent treatment option in adult pneumonia patients," said Dr. Antonio Anzueto, lead study author and professor of medicine, University of Texas Health Science Center, San Antonio."
In the CAPRIE study, hospitalized CAP patients aged 65 years or older were enrolled in a prospective, double-blind trial and randomized to sequential therapy from I.V. to oral forms of Avelox (400 mg once daily) or Levaquin (500 mg once daily). Most patients had multiple co-morbidities (such as chronic obstructive pulmonary disease (COPD), cardiac disease and diabetes) and 18 percent of patients had severe CAP.
In the 281 patients evaluated, Avelox was more effective in the treatment of mild to moderate CAP (92.6 percent vs. 88.6 percent Levaquin), severe CAP (94.7 percent vs. 84.6 percent Levaquin) and CAP in patients 75 years of age or older (94.5 percent vs. 90 percent Levaquin). Drug-related adverse events were similar for both antibiotics (26 percent Avelox vs. 23 percent Levaquin).
About CAP
CAP affects 4.5 million adults in the U.S. annually(3), resulting in 10 million physician visits, 500,000 hospitalizations and 45,000 deaths each year.(4) CAP is the fifth leading cause of death among people older than 65 years,(5) and a larger percentage of these patients have frequent co- morbidities and require hospitalization and longer hospital and intensive care unit (ICU) stays.(6)
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 greater than or equal to 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 http://www.aveloxusa.com/ or call Bayer Clinical Communications at 800-288-8371.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://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.
*Levaquin is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. (1) Stanton, M. Research in Action, Issues 7: Improving Treatment Decisions for Patients with Community-Acquire Pneumonia. Available at http://www.ahrq.gov/clinic/pneumonia/pneumonria.htm . Accessed on September 21, 2004. (2) Houck, P. et al. Timing of Antibiotic Administration and Outcomes for Medicare Patients Hospitalized with Community-Acquired Pneumonia. Arch Intern Med. 2004;164:637-644 (3) Thibodeau, K.P. and Anthony J. Viera. Atypical pathogens and challenges in community-acquired pneumonia. American Family Physician 20004; 69: 1699-1706. (4) Bartlett, J. et al. Practice Guidelines for the Management of Community-Acquired Pneumonia in Adults. Clin Infect Dis 2000; 31:347-82 (5) Houck, P. et al. Timing of Antibiotic Administration and Outcomes for Medicare Patients Hospitalized with Community-Acquired Pneumonia. Arch Intern Med. 2004;164:637-644 (6) Niederman, M. Community-acquired Pneumonia: Management Controversies, Part I; Practical Recommendations from the Latest Guidelines. Am J Respir Crit Care Med. 2001(5)
Web sites: http://www.AveloxUSA.com http://www.bayerpharma.com http://www.ahrq.gov/clinic/pneumonia/pneumonria.htm
Bayer HealthCare PharmaceuticalsCONTACT: Staci Gouveia, Bayer Pharmaceuticals Corporation,+1-203-812-6152, fax: +1-203-812-3504