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Avelox® information for Healthcare Professionals


10 years of Avelox® - i.v. in 105 countries

Clinical Data for Avelox® in Acute Exacerbation of Chronic Bronchitis

The treatment of acute exacerbations of chronic bronchitis (AECB) with Avelox® (moxifloxacin) versus standard regimens has been investigated in many studies. With respect to efficacy, 5 days of Avelox® therapy has been demonstrated to be equivalent to 7 days amoxicillin, clarithromycin, cefuroxime-axetil, amoxicillin-clavulanate and levofloxacin. The incidence of adverse events was comparable between the moxifloxacin and comparator groups in each study.


Table 1. Summary of Selection of Clinical Trials of Avelox® in Acute Exacerbation of Chronic Bronchitis

Study
(Author)
Study/AuthMOSAIC1 (WILSON, et al.)
Study Design Prospective, multinational, multicentre, randomised, double-blind study
Patients were then followed up for 9 months or until their next exacerbation
Avelox® Regimen Dose:PO 400mg od
Duration:5 days
Comparator Drug/dose:Amoxicillin PO 500mg tds or clarithromycin PO 500mg bd or cefuroxime-axetil PO 250mg bd
Duration:7 days
No. of
patients (n) †		 572
Primary Endpoint Clinical success assessed 7 to 10 days after the end of treatment, defined as the proportion of patients with clinical cure or improvement according to the following definition:
  • clinical cure (return to pre-exacerbation status, no additional antimicrobial therapy required)
  • clinical improvement (not complete return to pre-exacerbation status, but sufficient improvement in clinical signs and symptoms that no alternative antimicrobial therapy was required)
  • clinical failure (no change, worsening, insufficient improvement or reappearance of signs and symptoms of infection such that alternative antimicrobial therapy is required)
  • indeterminate (clinical assessment not possible)
Efficacy Results (Avelox® vs Comparator) Percentage of patients achieving primary endpoint:
87.2% (Avelox® 400mg) vs 84.2% (comparator therapy)
(95% CI: -3.0 to 8.5) non-inferiority between treatment groups

Clinical cure rates (return to pre-exacerbation health status):
69.7% (Avelox® 400mg) vs 62.1% (comparator therapy)
(95% CI: 0.3, 15.6) superiority in favour of Avelox®

Bacteriological eradication rates:
91.5% (Avelox® 400mg) vs 81.0% (comparator therapy)
(95% CI: 0.4, 22.1) superiority in favour of Avelox®

Exacerbation-free interval (time from randomisation to next exacerbation)(ITT population):
132.8 days (Avelox® 400mg) vs 118 days (comparator therapy)
(P=0.03) superiority in favour of Avelox®

Use of additional post-therapy antibiotics to treat the exacerbation:
9.5% (Avelox® 400mg) vs 15.1% (comparator therapy)
(P = 0.045) superiority in favour of Avelox®
See Figure 1 and Figure 2


Life-table analysis of time to the first composite event (treatment failure, and/or new exacerbation and/or any further antibiotic treatment) stratified according to the time of the last exacerbation prior to randomisation.
Avelox vs Amoxicillin Clinical Response

Safety Results (Avelox® vs Comparator)* Percentage of patients experiencing a drug-related adverse event:
7.1% (Avelox® 400mg) vs 4.8% (comparator therapy)
Study/AuthEFEMAP2 (MIRAVITLLES, et al.)
Study Design Prospective, multicentre, observational, non-randomised, open-label study
Avelox® Regimen Dose:PO 400mg od
Duration:5 days
Comparator Drug/dose:Amoxicillin/clavulanate PO 500/125mg tds or clarithromycin PO 500mg bd
Duration:10 days
No. of
patients (n) †		 1,456
Primary Endpoint Clinical success (cure or clinical improvement) at day 10
Efficacy Results (Avelox® vs Comparator) Percentage of patients achieving primary endpoint:
97.2% (Avelox® 400mg) vs 93.1% (amoxicillin/clavulanate) vs 94.4% (clarithromycin)
(P=0.40) no statistically significant difference between treatment arms

Clinical cure rate on day 3:
20.0% (Avelox® 400mg) vs 9.6% (amoxicillin/clavulanate) and 6.5% (clarithromycin)
(P<0.001) superiority in favour of Avelox® vs. both comparator arms

Clinical cure rate on day 5:
49.0% (Avelox® 400mg) vs 26.5% (amoxicillin/clavulanate) and 30.0% (clarithromycin)
(P<0.001) superiority in favour of Avelox® vs. both comparator arms

Clinical cure rate on day 10:
67.3% (Avelox® 400mg) vs 65.1% (amoxicillin/clavulanate) vs 64.0% (clarithromycin)
(P=0.38) no statistically significant difference between treatment arms Avelox vs Amoxicillin Clinical Response
Safety Results Safety data not reported
Study/AuthURUETA-ROBLEDO3 (URUETA-ROBLEDO, et al.)
Study Design Prospective, multinational, multicentre, randomised, double-blind study
Avelox® Regimen Dose:PO 400mg od
Duration:5 days
Comparator Drug/dose:Levofloxacin PO 500mg od
Duration:7 days
No. of
patients (n) †		 437
Primary Endpoint Clinical cure 7-14 days after therapy
Efficacy Results (Avelox® vs Comparator) Percentage of patients achieving primary endpoint:
91.0% (Avelox® 400mg) vs 94.0% (levofloxacin)
(95% CI: -7.3, 2.29) non-inferiority between treatment groups
Safety Results (Avelox® vs Comparator)* Percentage of patients experiencing a drug-related adverse event:
23.7% (Avelox® 400mg) vs 26.9% (levofloxacin)
Study/AuthGRASSI4 (GRASSI, et al.)
Study Design Prospective, multicentre, open-label, randomised study
Avelox® Regimen Dose:PO 400mg od
Duration:5 days
Comparator Drug/dose: Ceftriaxone IM 1g od
Duration:7 days
No. of
patients (n) †		 423
Primary Endpoint Clinical success (cure or clinical improvement) rate within 10 days after therapy
Efficacy Results (Avelox® vs Comparator) Percentage of patients achieving primary endpoint:
90.6% (Avelox® 400mg) vs 89.0% (ceftriaxone)
(Odds ratio 1.197; 95% CI: 0.634, 2.258) non-inferiority between treatment groups
Safety Results (Avelox® vs Comparator)* Percentage of patients experiencing a drug-related adverse event:
5.0% (Avelox® 400mg) vs 0.4% (ceftriaxone)
Table Key

† All patient numbers are the per protocol population
* P value data are not always included in the original paper
od Once daily
bd Twice daily
tds Three times daily
CI Confidence interval
IM Intramuscular
PO Per oral


Data for Figure 1 was taken from the MOSAIC1 trial, a multicentre, multinational, randomised, double-blind study (n=730) comparing moxifloxacin 400mg od for 5 days with amoxicillin 500mg tds, for 7 days, clarithromycin 500mg bd for 7 days or cefuroxime-axetil 250mg bd for 7 days.

Avelox® : Superior Clinical cure in Patients with AECB

* Comparator therapy=amoxicillin, cefuroxime-axetil or clarithromycin

All patient numbers are the per protocol population.

Figure 1. Avelox® : Superior Clinical Cure in Patients with AECB1

In patients with AECB, 5 days of Avelox® was clinically superior to 7 days of standard first-line antibiotic therapy in terms of clinical cure rates.


Data for Figure 2 was taken from the MOSAIC1 trial, a multicentre, multinational, randomised, double-blind study (n=730) comparing moxifloxacin 400mg od for 5 days with amoxicillin 500mg tds, for 7 days, clarithromycin 500mg bd for 7 days or cefuroxime-axetil 250mg bd for 7 days.1

Avelox Extended Exacerbation-Free Interval

* Comparator therapy=amoxicillin, cefuroxime-axetil or clarithromycin

The extended exacerbation-free interval data is based on the intent-to-treat population minus those patients who received additional antibiotic therapy (n=643).

Figure 2. Avelox® : Extended Exacerbation-Free Interval1

References

  1. Wilson R, et al, CHEST 2004; 125: 953–964.
  2. Miravitlles M, et al. Clin Drug Invest 2004; 24: 63-72.
  3. Urueta-Robledo J, et al. Respir Med. 2006; 100:1504-1511.
  4. Grassi C, et al. J Chemother. 2002; 14: 597-608.

For further information on using Avelox® in the management of bacterial infections, please consult your local country specific prescribing information.
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