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Subgroup Analysis of MOSAIC Study Demonstrated that Treatment with AveloxÒ (moxifloxacin HCl) Provided More Time Between Bronchitis Flare-Ups and Fewer Follow-Up Antibiotics Compared to Standard Treatments
ORLANDO, FLORIDA, October 27, 2003 – Study results presented today showed that patients with acute exacerbations of chronic bronchitis (AECB) who took a five-day course of the antibiotic Avelox® (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.
The study, presented at CHEST 2003, the annual meeting of the American College of Chest Physicians, was comprised of an analysis of patient subgroups from the MOSAIC study, a major, international clinical trial in AECB.
Avelox demonstrated significantly higher bacteriologic eradication rates in all subgroups analyzed as compared to patients who received clarithromycin, amoxicillin, or cefuroxime-axetil. These results were consistent among all prognostic subgroups, including the most severely ill patients, who were identified by factors such as co-existing cardiopulmonary disease and a period of less than six months between AECB.
"This analysis of the MOSAIC study further confirms moxifloxacin’s place in the treatment of respiratory tract infections, such as AECB," said Michael Niederman, MD, Chairman, Department of Medicine, Winthrop University Hospital, Mineola, NY. "These results are especially important because they indicate that moxifloxacin has excellent clinical success in the treatment of severe AECB patients - and those who have severe airflow obstruction but are not receiving corticosteroids."
In patients with chronic bronchitis, AECB is the sudden onset of increased mucus production, increased mucus purulence (pus content), increased cough and increased shortness of breath. Repeated episodes or exacerbations of AECB are often caused by bacterial infections, which may cause progressive lung damage and may lead to deteriorating lung function over time. Each year, about 11 million Americans are diagnosed with chronic bronchitis and more than $15 billion are spent each year to treat the condition.
In the subgroup analysis presented at CHEST, patients who had four or more acute exacerbations of chronic bronchitis each year; co-existing cardiopulmonary disease; a forced expiratory volume (FEV1) of less than 70% of the value predicted at enrollment (85%), indicating airflow obstruction; concomitant steroid use; experienced symptoms of chronic bronchitis for over 15 years or were greater than 65 years of age. Avelox demonstrated a higher patient cure rate across all factors, which included: more than four AECB episodes per year (59% of Avelox patients vs. 55% of standard therapy patients, p=0.06); cardiopulmonary disease (56% of Avelox patients vs. 38% of standard therapy patients, p=0.05); a FEV1 of greater than or equal to 70% (80% of Avelox patients vs. 68% of standard therapy patients, p=0.06); concomitant steroid use (67% of Avelox patients vs. 59% of standard therapy patients, p=0.14); experienced symptoms of chronic bronchitis for greater than or equal to 15 years (67% of Avelox patients vs. 58% of standard therapy patients, p=0.06); and were 65 years of age or older (67% of Avelox patients vs. 59% of standard therapy patients, p=0.05).
Previously, antibiotic studies in AECB have been limited by inadequate information on patient condition prior to AECB, lack of studies conducted in heterogenous 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 (69.7% vs. 62.1% in the comparator arm) and a significantly higher bacteriological response rate (92% vs. 81% in the comparator arm). The number of patients requiring additional antibiotics was significantly lower (9.5%) compared to standard therapies (15.1%, p=0.05), and fewer Avelox patients required post-therapy systemic antimicrobials (8.8% vs. 14.8% in the comparator arm). 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.
About AVELOX
Avelox is approved to treat: Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including penicillin-resistant strains, MIC value for penicillin ³ 2 m g/mL), Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; and uncomplicated Skin and Skin Structure Infections (uSSSI) caused by Staphylococcus aureus or Streptococcus pyogenes.
Important Safety Considerations
Avelox is a prescription medication that is generally well tolerated. The most common side effects, which are usually mild, include nausea, diarrhea, and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness.
You should not take Avelox if you have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. You should avoid taking Avelox if you have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol.
If you are pregnant or planning to become pregnant while taking Avelox, talk to your healthcare provider before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
Avelox is not recommended for children under the age of 18 years.
Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. You should take Avelox either four hours before or eight hours after taking these products.
Be sure to inform your healthcare provider of any medical conditions you have and all prescription and non-prescription medications or supplements you are taking. If you have any concerns about your medication or side effects, please contact your healthcare provider.
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