Moderator Comments:
How then does one explain the following press release from Bayer Pharmaceuticals when it has been proven that the use of vitamin C rather than an antibiotic is just as effective? Combining the Gonzales and Evans study we find about 24 million prescriptions for an antibiotic in which 90% (21.6 million patients) would receive no greater benefit than if they had taken vitamin C.

Bayer stated that "Study results showed that Avelox had a significantly greater clinical cure rate compared to the standard treatments…" If indeed such a "clinical cure rate" did in fact occur why then do we find reference to the recurrence of this disease state in the patients treated within Bayer's study? One has to seriously wonder what the results would have been had Bayer compared this toxic chemotherapeutic agent with everyday vitamin C. I have no doubt that we would find the same results as posted by Evans et al.

Within Evans study we find a cure rate of 89% regardless whether the patient had taken an antibiotic or not. Yet within the study referred to in the following press release, Bayer stated that Avelox demonstrated a significantly higher clinical cure rate of 70.9%. Within Evans study we find a cure rate of 89% for patients who received NO antibiotics whatsoever.

One has to seriously consider whether or not the patient's condition would have resolved whether they were given antibiotics or not. If indeed the antibiotic, Avelox, had successfully eradicated the bacteria causing this disease state, one has to wonder why then that these patients within Bayer's study had a reoccurrence that manifested two weeks later than those who had taken true antibiotics rather than a dangerous chemotherapeutic agent.

Bayer Pharmaceuticals Release: New Study Shows Excellent Clinical Results For Patients With Acute Exacerbations Of Chronic Bronchitis
CHICAGO, Sept. 16 /PRNewswire/ -- Study results presented today showed that patients with acute exacerbations of chronic bronchitis (AECB) who took a five-day course of the antibiotic Avelox(R) (Moxifloxacin HCl) required fewer follow-up antibiotics to achieve clinical success and experienced significantly more time to next AECB reoccurrence than patients who took a seven-day course of standard antibiotics. Study results showed that Avelox had a significantly greater clinical cure rate compared to the standard treatments with clarithromycin, amoxicillin, or cefuroxime-axetil. The study also demonstrated excellent clinical success, as a five-day course of Avelox once daily was equivalent to comparators taken for seven days either two or three times a day.

Avelox demonstrated a higher patient cure rate across all factors, which included: more than four AECB episodes per year (63% of Avelox patients vs. 58% of standard therapy patients, p=0.02); cardiopulmonary disease (62% of Avelox patients vs. 42% of standard therapy patients, p=0.02); a FEV1 of greater than or equal to 50% (79% of Avelox patients vs. 69% of standard therapy patients, p=0.02); less than six months since previous AECB to randomization (64% of Avelox patients vs. 61% of standard therapy patients, p=0.02) and concomitant steroid use (67% of Avelox patients vs. 62% of standard therapy patients, p=0.02).

Previously, antibiotic studies in AECB have been limited by inadequate information on patient condition prior to AECB, lack of studies conducted in heterogeneous or nonrepresentative patient populations and single comparator selection, as well as lack of long-term follow-up and prospective control for prognostic factors. The MOSAIC study, on which this subgroup analysis was based, was undertaken to addresses these shortcomings.

The MOSAIC Study

MOSAIC was a multi-center, multi-national, randomized, double blind study of two parallel treatment arms designed to reproduce the real-world conditions of the physician's office. Enrolled patients were 45 years of age or older who had stable chronic bronchitis and severe AECB within 12 months of enrollment. During a 12-month monitoring period, 730 patients had an AECB episode and were randomized 1:1 to receive Avelox (400mg, once daily, for five days) or a standard treatment regimen consisting of amoxicillin (500mg, three times daily, for seven days) or clarithromycin (500mg, twice daily, for seven days) or cefuroxime-axetil (250mg, twice daily, for seven days).

Unlike other antibiotic trials in AECB, patients in the MOSAIC study were assessed prior to the exacerbation to establish their baseline state and monitored during and after treatment to determine the time they required to return to baseline. The primary endpoint was clinical success (resolution and improvement) at seven-to-ten days post treatment. Patients also scheduled a follow-up visit after nine months to assess long-term outcomes, including time until their next exacerbation.

Avelox demonstrated a significantly higher clinical cure rate (70.9 percent vs. 62.8 percent in the comparator arm) and a significantly higher bacteriological response rate (92 percent vs. 81 percent in the comparator arm). The number of patients requiring additional antibiotics was significantly lower (31 percent) compared to standard therapies (40 percent, p=0.03), and fewer Avelox patients required post-therapy systemic antimicrobials in both the per-protocol and intent-to-treat populations. Time to next exacerbation measured at nine-month follow-up showed that for patients who took Avelox, the average interval between episodes of AECB was approximately two weeks longer than for those who took standard therapy.

Adverse events considered as possibly or probably related to study drug were reported in a similar number of patients in both groups: 25 in Avelox group (7.1%) versus 18 in comparator arm (4.8%). These events were usually mild to moderate in intensity.

Of 43 serious adverse events, 19 were reported in the Moxifloxacin arm and 24 in the comparator arm. Two serious events were considered possibly related to study medication in the comparator arm, both of which resolved. There were nine deaths during the study, three in the Moxifloxacin arm and six in the comparator arm; none were associated with study treatment.