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Published on 1/24/2006 in the Prospect News Biotech Daily.

Schering-Plough: study shows favorable results of using Avelox for pneumonia

By Lisa Kerner

Erie, Pa., Jan. 24 - Schering-Plough Corp. said results of its first comparative, head-to-head evaluation of two fluoroquinolone antibiotics in hospitalized elderly patients with community-acquired pneumonia (CAP) showed that 97.9% Avelox (moxifloxacin HCl) patients recovered at days 3 to 5 compared to 90% of Levaquin (levofloxacin) patients.

Avelox, developed by Bayer Pharmaceuticals Corp., is marketed in the United States by Schering-Plough.

Levaquin is a product of Ortho-McNeil Pharmaceutical.

The clinical study, called Caprie (Community-Acquired Pneumonia Recovery In the Elderly), is one of only a few studies that have specifically evaluated CAP treatment among the elderly age 65 or older and the very elderly age 75 or older. These patients are 60% more likely to contract CAP than the general population, according to a company news release.

The Caprie study was a prospective, randomized, controlled, double-blind, double-dummy, comparative study conducted at 47 centers across the United States. Patients were randomized to receive I.V./oral Avelox 400 mg once daily or I.V./oral Levaquin 500 mg once daily for 7 to 14 days. The study enrolled 394 patients. Most patients had multiple co-morbidities, including chronic obstructive pulmonary disease, cardiac disease and diabetes, and 16% of patients had severe CAP.

The study results were published in the current issue of Clinical Infectious Diseases.

There was no significant difference between the two treatments with regard to cardiac safety, the primary endpoint of the study, or clinical cure rates 5 to 21 days after the end of treatment, the primary efficacy endpoint.

The rates of investigator-reported drug-related adverse events in the study were similar for both treatment regimens.

"The incidence of pneumonia increases with age and elderly pneumonia patients are a vulnerable patient population that faces a high mortality rate when they enter a hospital," said Dr. Antonio Anzueto, lead study author and associate professor of medicine, University of Texas Health Science Center, San Antonio. "The Caprie study findings not only reinforce that Avelox is an effective and safe treatment option for elderly patients with CAP, but also show that more patients taking Avelox recovered at days 3 to 5 compared to patients taking Levaquin."

Each year there are nearly 1 million cases of community-acquired pneumonia among the elderly in the United States. It is the fifth leading cause of death in the elderly, according to the release.

Avelox was developed by Bayer Pharmaceuticals Corp. and is marketed in the United States by Schering-Plough.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products.


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