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| |  Avelox (Moxifloxacin) Equally or More Effective Than Zithromax (Azithromycin) in Bacterial Bronchitis TORONTO, ON -- May 10, 2000 -- Five-day treatment with Avelox(TM) (moxifloxacin HCl), a new fluoroquinolone approved in December last year by the U.S. Food and Drug Administration for the treatment of common respiratory tract infections, is equally or more effective in treating acute bacterial exacerbations of chronic bronchitis (ABECB) than Zithromax(TM) (azithromycin), the most commonly prescribed antibiotic for the condition, according to a study presented at the annual meeting of the American Thoracic Society. The study found that a five-day course of moxifloxacin was as effective as a five-day course of azithromycin against some common ABECB pathogens, but more effective than azithromycin against others. Currently, moxifloxacin and azithromycin are the only antibiotics approved for five-day treatment of ABECB. "Moxifloxacin also appeared to eradicate causative pathogens more rapidly than azithromycin," said C.Andrew DeAbate, MD, director at Medical Research Centers in New Orleans and a principal investigator of the study. During his poster presentation he said that an additional analysis of a subset of the data showed that moxifloxacin eradicated the causative pathogen by the third day of therapy in 63 percent of patients, compared to 48 percent for azithromycin. "If confirmed in additional studies, a more rapid action of moxifloxacin would be important because morbidity is high in ABECB patients - the sooner their symptoms improve, the better," he said. He also said that no bacterial strains from study patients before therapy were resistant to moxifloxacin, but 14 percent were resistant to azithromycin. "The lack of resistance to moxifloxacin is reassuring because resistance of respiratory tract pathogens to many antibiotics has been increasing in recent years," he said. The study was a prospective, double-blind, randomized clinical trial in 567 adult patients with suspected ABECB from 37 health centers in the U.S. and Canada. Patients were randomly assigned to five days of treatment with either moxifloxacin 400 mg once daily or azithromycin (500 mg on the first day followed by 250 mg per day for the next four days). They were clinically evaluated prior to therapy, at the end of therapy (days 0 to 6), and post therapy (days 14 to 21, "test of cure"); bacteriologic evaluations were performed before therapy, during therapy (days 1 to 5), at the end of therapy and post therapy. Of the 567 patients who began the study, 464 (221 Avelox and 243 azithromycin) completed therapy and were considered valid for analysis of clinical response; of these, 237 were valid for microbiological analyses. Clinical cure at the end of therapy, defined as disappearance of symptoms based on clinical exam or sufficient improvement so that further antimicrobial therapy was not needed, was the same for both moxifloxacin and azithromycin groups: 90 percent and 92 percent, respectively. Bacteriologic responses, defined as eradication of bacteria present in sputum culture, were similarly equivalent for the two groups: 96 percent and 94 percent, respectively. Moxifloxacin was 100 percent effective by end of therapy in eradicating the most commonly isolated pathogens from patients: H.influenzae, M.catarrhalis, S. pneumoniae, H. parainfluenzae, and S. aureus. Azithromycin eradicated 77 percent of H. parainfluenzae, 92 percent of H. influenzae, and 100 percent of the other three common pathogens. The frequency of drug-related adverse events were similar for both treatment groups (22 percent of moxifloxacin patients and 17 percent of azithromycin patients). Most events were mild to moderate in severity and resolved without intervention. The most common side effects were diarrhea and nausea. "Compared to azithromycin, moxifloxacin may be a more preferred treatment for many ABECB patients because it may act more quickly, is more effective against common pathogens and does not appear to be as vulnerable to resistance," said Dr. DeAbate. "The short, five-day course of moxifloxacin may also improve patient compliance, and therefore decrease reinfections and save on treatment costs," he said.
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