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Biaxin XL (R) (Clarithromycin extended-release tablets) and Levaquin(R) achieve similar results for community-acquired pneumonia

San Francisco, Calif., May 23, 2001 A new study comparing Biaxin XL(R) (clarithromycin extended-release tablets) and another leading, once-daily antibiotic, Levaquin(R) (levofloxacin tablets, Johnson & Johnson) shows that Biaxin XL and Levaquin had similar results in patients with community-acquired pneumonia (CAP). The results presented today at the 97th annual meeting of the American Thoracic Society showed that patients receiving Biaxin XL achieved a clinical cure rate of 88 percent, similar to those taking the quinolone, Levaquin, who achieved an 86 percent clinical cure rate.

Biaxin XL is the once-daily formulation of Abbott Laboratories widely prescribed, advanced-generation macrolide antibiotic, Biaxin(R)(clarithromycin tablets), and in March 2000 was approved by the U.S. Food and Drug Administration for the treatment of mild-to-moderate acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis in adults. The efficacy and safety of Biaxin XL in treating other infections for which other formulations of Biaxin are approved have not been established.

These data are of interest because as many as three million Americans are affected each year by community-acquired pneumonia, said Dan Dattani, M.D., principal investigator, Prairie Clinical Research Group, assistant clinical professor of Family Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada, and lead investigator in this study. These data show that Biaxin and Levaquin had similar results in patients with this respiratory infection.

Study Results

Biaxin XL and Levaquin were compared in a double-blind, parallel-group, multicenter study in 299 ambulatory patients with CAP. Patients were randomized to receive either 1,000 mg of Biaxin XL (2 x 500mg tablets) once-a-day for seven days, or 500 mg of Levaquin (2 x 250mg tablets) once-a-day for seven days. Efficacy evaluations were made at the test-of-cure visit (seven to 14 days after compl
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Contact: Tina Brookhouse
847-935-9390
Porter Novelli
22-May-2001


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