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Once-Daily Telithromycin Effective for Acute Exacerbations of Chronic Bronchitis: Presented at ATS

By Charlene Laino

SEATTLE, WA -- May 22, 2003 -- For patients with acute exacerbations of chronic bronchitis (AECB), once-daily telithromycin treatment for 5 days is as effective as commonly used antibiotics taken two to three times daily for 10 days, a new study shows.

Marcus J. Zervos, MD, of William Beaumont Hospital Research Institute, in Royal Oak, Michigan, United States, presented the findings here on May 19^th at the American Thoracic Society International Conference.

To assess clinical and bacteriologic outcomes 17 to 21 days after treating patients with telithromycin, Dr. Zervos and colleagues analyzed data from three Phase III, multicenter, randomized, double-blind trials.

They compared outcomes in 615 patients treated with telithromycin 800 mg once daily for 5 days; 160 patients treated with amoxicillin-clavulanic acid 500/125 mg three times daily for 10 days; 191 patients treated with cefuroxime axetil 500 mg twice daily for 10 days; and 282 patients treated with clarithromycin 500 mg twice daily for 10 days.

The researchers conducted a separate analysis of patients at increased risk due to being age 65 or older, severe pulmonary obstruction, or concomitant disease..

Patients treated with telithromycin had an 87.1% overall clinical cure rate, defined as a return to preinfection state or improvement in current infection. This compared with 85.6% for comparators groups, the study showed.

For older patients, the clinical cure rate was 85.1% in the telithromycin group and 84.5% for those treated with other antibiotics.

The clinical cure rates in patients with one or two risk factors for increased morbidity were 85.9% and 83.6%, respectively, in the telithromycin group versus 84.6% and 83.6%, respectively, for comparators.

"Telithromycin is consistently effective in patients with acute exacerbations of chronic bronchitis, even in those patients with higher morbidity risk," Dr. Zervos said.

"With antibiotic resistance [being] a growing problem, an effective and convenient antibiotic treatment that is specifically designed to treat respiratory tract infections would be a valuable therapeutic option for patients and physicians," he said.

Telithromycin is the first agent in a new class of antibiotics known as ketolides, which deliver a tailored spectrum of activities and require a short-treatment duration for upper and lower respiratory tract infections. In previous clinical trials, the most commonly reported side effects were diarrhea, nausea, and vomiting.

The drug is currently awaiting U.S. Food and Drug Administration approval.

Aventis, which manufactures telithromycin, funded the study.


[Study title: Telithromycin (TEL) Efficacy in Patients with Acute Exacerbations of Chronic Bronchitis (AECB) and Increased Morbidity Risk. Poster B27]

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