- Home
- Product Information
- Indications
- Administration
- In Vitro Activity and Mechanism of Action
- Clinical Efficacy
- Community Acquired Pneumonia
- Acute Exacerbation of Chronic Bronchitis
- Acute Bacterial Sinusitis
- Mild to Moderate Pelvic Inflammatory Disease
- Complicated Skin and Skin Structure Infections
- Complicated Intra-Abdominal Infections
- Safety
- FAQs
- Disease Area Information
Clinical Data for Avelox® in Acute Bacterial Sinusitis
In five studies of patients with acute bacterial sinusitis (ABS), Avelox® (moxifloxacin) use showed clinical success rates from 86.0% to 96.7%. When Avelox® was compared with cefuroxime-axetil it conferred significantly higher clinical cure rates with a slightly higher incidence of adverse events.
Table 1. Summary of Selection of Clinical Trials of Avelox® in Acute Bacterial Sinusitis
Study
(Author)
(Author)
- SIEGERT1
(SIEGERT et al.) - RAKKAR2
(RAKKAR et al.) - ARRIETA3
(ARRIETA et al.) - SPEED4
(ARIZA et al.) - GEHANNO5
(GEHANNO et al.)
| Study/Auth | SIEGERT1 (SIEGERT et al.) |
| Study Design | Prospective, multinational, multicentre, randomised, double-blind study |
| Avelox® Regimen | Dose: PO 400mg od Duration:7 days |
| Comparator | Drug/dose: Cefuroxime-axetil PO 250mg bd Duration:10 days |
| No. of patients (n) † |
436 |
| Primary Endpoint | Clinical cure at day 14 post start of therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 96.7% (Avelox® 400mg) vs 90.7% (cefuroxime-axetil) (95% CI: 1.5, 10.6) superiority in favour of Avelox® See Figure 1 |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 31.0% (Avelox® 400mg) vs 22.0% (cefuroxime-axetil) |
| RAKKAR2 (RAKKAR et al.) | |
| Study Design | Prospective, multinational, multicentre, randomised, open-label study |
| Avelox® Regimen | Dose:PO 400mg od Duration:10 days |
| Comparator | Drug/dose: Amoxicillin/clavulanate PO 875/125mg bd Duration:10 days |
| No. of patients (n) † |
341 |
| Primary Endpoint | Clinical resolution (cure or clinical improvement) 14-21 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 86.0% (Avelox® 400mg) vs 84.0% (amoxicillin/clavulanate) (95% CI: -7.0, 13.0) non-inferiority between treatment groups  |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 30.0% (Avelox® 400mg) vs 25.0% (amoxicillin/clavulanate) |
| ARRIETA3 (ARRIETA et al.) | |
| Study Design | Prospective, multinational, multicentre, randomised, open-label study |
| Avelox® Regimen | Dose:PO 400mg Duration:7 days |
| Comparator | Drug/dose: Amoxicillin/clavulanate PO 500/125mg tds Duration:10 days |
| No. of patients (n) † |
459 |
| Primary Endpoint | Clinical cure at 7-14 days after therapy |
| Efficacy Results (Avelox® vs Comparator) |
Percentage of patients achieving primary endpoint: 93.4% (Avelox® 400mg) vs 92.7% (amoxicillin/clavulanate) (95% CI: -3.93, 5.36) non-inferiority between treatment groups |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 32.2% (Avelox® 400mg) vs 29.7% (amoxicillin/clavulanate) |
| SPEED4 (ARIZA et al.) | |
| Study Design | Prospective, multicentre, single-arm, open-label study |
| Avelox® Regimen | Dose:PO 400mg od Duration:10 days |
| Comparator | None |
| No. of patients (n) † |
42 |
| Primary Endpoint | Proportion of patients with bacteriologic eradication of pre-therapy pathogens on Days 2, 3, and 4 |
| Efficacy Results |
Percentage of patients achieving primary endpoint: By Day 2: 83.3% (Avelox® 400mg) (95% CI: 68.6, 93.0) By Day 3: 100.0% (Avelox® 400mg) (95% CI: 91.6, 100.0) By Day 4: 97.6% (Avelox® 400mg) (95% CI: 87.4, 99.9) |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 16.0% (Avelox® 400mg) |
| GEHANNO5 (GEHANNO et al.) | |
| Study Design | Prospective, multicentre, single arm study in patients with maxillary sinusitis who failed previous therapy or had a higher risk of complications, such as frontal, sphenoidal sinusitis or pansinusitis |
| Avelox® Regimen | Dose:PO 400mg od Duration:10 days |
| Comparator | None |
| No. of patients (n) † |
216 |
| Primary Endpoint | Clinical cure at 7-10 days after therapy |
| Efficacy Results |
Percentage of patients (overall population) achieving primary endpoint: 92.6% (Avelox® 400mg) Percentage of patients with acute sinusitis after first-line treatment failure achieving clinical success: 94.9% (Avelox® 400mg) Percentage of patients with sinusitis with risk of complications achieving clinical success: 82.9% (Avelox® 400mg) |
| Safety Results (Avelox® vs Comparator)* | Percentage of patients experiencing a drug-related adverse event: 12.2% (Avelox® 400mg) |
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
PO Per oral
Data for Figure 1 was taken from SIEGERT, a prospective, randomised, double-blind, Phase III clinical trial (n=436) comparing moxifloxacin 400mg PO od for 7 days with cefuroxime-axetil 250mg bd, 10 days1.
All patient numbers are the per protocol population.
Figure 1. Avelox® : Significantly Higher Clinical Success Rates Than Comparator Therapy1
References
- Siegert I, et al. Respir Med 2000; 94: 337-344.
- Rakkar S, et al. Int J Clin Pract 2001; 55: 309-315.
- Arrieta JR, et al. Am J Otolaryngol 2007; 28: 78-82.
- Ariza H, et al. BMC Ear, Nose and Throat Disorders 2006, 6:8.
- Gehanno P, et al. J Int Med Res 2003; 31: 434 – 447.
