Efficacy and Tolerability of Moxifloxacin in Patients With Sinusitis Treated in General Practice

W. Elies; H. Landen; K. Stauch


Clin Drug Invest. 2004;24(8) 

In This Article


Antibiotic therapy with moxifloxacin in this large-scale PMS study resulted in rapid improvement in symptoms of acute sinusitis. Moxifloxacin was remarkably well tolerated in the examined patient population, with only a small proportion of patients experiencing adverse events.

Diagnosis of bacterial sinusitis was left largely to the physician's discretion. Although no specific information was collected on the establishment of bacterial aetiology, the results are supportive of evidence from controlled clinical trials of moxifloxacin in the treatment of bacterial sinusitis in more rigidly defined environments.

In a double-blind, comparative clinical study, moxifloxacin therapy showed a significantly higher response rate than cefuroxime axetil 250mg twice daily, even though the latter was administered for 10 days (96.7% vs 90.7%).[22] It also produced higher bacteriological eradication rates than cefuroxime axetil (94.5% vs 83.5%) in this study. In an open study in the primary-care setting, 475 adult patients with acute sinusitis received either moxifloxacin 400mg once daily or amoxicillin/clavulanic acid 875mg twice daily for 10 days.[23] Moxifloxacin was as effective and safe as twice-daily amoxicillin/clavulanic acid, with the advantage of producing significantly more rapid relief of symptoms.

Moxifloxacin has also demonstrated a high degree of effectiveness in the treatment of other common RTIs.[37-39] Clinical response rates of >95% have been reported in patients with AECB treated with moxifloxacin 400 mg/day for 5–7 days.[33,35,39] In the MOSAIC study, a 5-day course of moxifloxacin was shown to have significant superiority over standard therapy for AECB (cefuroxime, clarithromycin or amoxicillin for 7 days).[40] Similar to the experience in patients with sinusitis, moxifloxacin tended to produce more rapid improvement in symptoms in patients with AECB.[25,26]

In patients with CAP, moxifloxacin is associated with eradication rates of up to 97% for all commonly encountered respiratory tract pathogens, and has demonstrated superiority to β-lactam therapy with or without macrolide therapy for CAP.[30,38,41,42,43] In a PMS study, moxifloxacin produced improvement in approximately 60% of patients after 3 days' treatment and in 90% of patients after 5 days.[38] Similar results were reported in CAP patients treated in a primary-care setting.[33]

The particular suitability of moxifloxacin for treating patients with bacterial sinusitis is underlined by findings that effective sinus tissue levels are rapidly achieved.[19] Following oral administration in patients with chronic sinusitis, moxifloxacin reached a mean plasma concentration of 2.32 mg/L at 2 hours, increasing to a maximum of 3.37 mg/L at 4 hours post-dose. The concentration of moxifloxacin in sinus mucosa was consistently greater than in plasma and exceeded the minimum inhibitory concentration at which 90% of bacteria are inhibited (MIC90) of all pathogens commonly encountered in acute sinusitis.[19]

The emergence of macrolide- and penicillin-resistant strains of S. pneumoniae in recent years has focused attention on providing antibiotic cover that is both highly active and reliable. The prevalence of resistant strains of S. pneumoniae has risen dramatically in the past decade and now typically exceeds 10%, and is ≥20% in some instances.[44,45,46,47,48,49,50,51,52] Despite this development, fluoroquinolones and especially moxifloxacin retain their activity against macrolide- or penicillin-resistant strains of S. pneumoniae and β-lactamase-producing H. influenzae and M. catarrhalis.[21,53]

In this study, very few patients (<0.4%) reported AEs during treatment with moxifloxacin. In most cases these consisted of gastrointestinal symptoms. To date, about 30 million patients have been treated with moxifloxacin worldwide and the overall tolerability profile is very good. No significant cardiac disorders were reported in the present study and moxifloxacin is not associated with clinically significant changes in renal, hepatic or cardiovascular function.[54]