The results of a novel "real world"
study comparing the antibiotics moxifloxacin and azithromycin for treating
acute exacerbations of chronic bronchitis (AECB) were presented today by
Siegfried Kreis, MD, from Providence Healthcare Network, at the annual meeting
of the American College of Chest Physicians and Clinical World Congress on
Diseases of the Chest (CHEST). The multi-center study was unique in that it
was based on patients treated by their usual physicians instead of by
investigators in a research setting. The findings showed that, although the
two antibiotics were equally effective in treating AECB, patients treated with
moxifloxacin felt better faster.
"AECB is one of the most common respiratory tract infections and any
treatment that helps patients feel better faster has implications for quality
of life issues such as returning to work and patient well being" said Dr.
Kreis, Chief of Infectious Disease and Chair of the Department of Internal
Medicine at Providence Healthcare Network. "These findings suggest
moxifloxacin may be a preferred choice of antibiotic for treating AECB," he
In the open-label study, 401 AECB patients from 74 physician practices
were treated with moxifloxacin 400 mg daily for five days or azithromycin 500
mg the first day and 250 mg for the next four days. The primary outcome
measure was the resolution of AECB symptoms (e.g., fever, coughing, shortness
of breath) at 14-21 days ("test of cure"). Secondary outcomes were continued
symptom resolution at 26-46 days after treatment ("follow-up") and patient
assessments of the length of time, from the first antibiotic dose, required to
perceive a clinical improvement and to return to normal activities.
Results showed moxifloxacin and azithromycin were equally effective at
resolving symptoms: 85 percent and 81 percent of patients, respectively, at
test of cure, and 81 percent and 79 percent, respectively, at follow-up.
However, patients' subjective assessments showed those receiving moxifloxacin
felt better sooner. For example, 40 percent of moxifloxacin patients reported
clinical improvement after three days compared to 27 percent of azithromycin
patients, a difference that was statistically significant (p < 0.012).
Similarly, more moxifloxacin patients (36 percent) reported resuming normal
activities after three days compared to azithromycin patients (26 percent), a
difference which was nearly significant (p = 0.07). Adverse events were low
for both regimens: 12 percent for moxifloxacin and 9 percent for azithromycin.
The majority of adverse events were gastrointestinal, specifically nausea and
diarrhea. Premature discontinuations due to adverse events were less than one
percent for both groups.
The findings were part of the Therapeutic Circles program, sponsored by
Bayer Corporation, which manufactures and markets moxifloxacin. An example of
a new trend in medical research, Therapeutic Circles was initiated August 1999
to complement moxifloxacin pivotal trials, and was designed to evaluate the
safety and effectiveness of the antibiotic in treating AECB patients seen in
common clinical settings rather than the more controlled conditions of
clinical trials. Unlike clinical trials, patients enrolled in the Therapeutic
Circles trial through their own family doctor, enhancing patient familiarity
and trust in their treatment. Physicians in the program were grouped into
"Therapeutic Circles" in which they could discuss trial experiences with peers
and gather qualitative information in addition to the usual quantitative
information on safety and efficacy typically assessed in clinical trials.
Dr. Kreis said that conducting the study in everyday clinical settings
makes the findings especially relevant to practicing physicians, and that
assessing factors such as subjective patient assessments, not usually done in
clinical trials, can provide valuable information. "The finding that patients
felt better faster on moxifloxacin is important to practicing
physicians -- and we wouldn't have known it without this type of study," he
explained. He said the findings were so compelling that they should be
verified in additional, larger studies.