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

Abstract and Introduction

Objective: To assess the efficacy, safety and tolerability of moxifloxacin, an 8-methoxy fluoroquinolone, in patients with respiratory tract infections (RTIs) treated in general practice in Germany. Different RTIs were analysed separately, and this paper focuses on patients with acute sinusitis.
Methods, design and patients: This was an open-label, prospective, uncontrolled, post-marketing surveillance study undertaken between October 2001 and June 2002. Symptoms of sinusitis (fever, cough, nasal obstruction, nasal secretion and headache) were assessed at baseline and at follow-up visits, and classified as 'absent', 'mild' or 'severe' by the attending physician.
Results: Altogether 9036 patients were treated with moxifloxacin, of whom 2405 adult men and women had sinusitis. Sinusitis symptoms were improved or cured in at least 92% of patients. Moxifloxacin produced significant improvements after only 3 days (71.6% of patients); 96.2% of patients were improved after 5 days. Most patients (89.5%) had recovered by day 8 and 97.3% by day 10. Physicians rated moxifloxacin therapy as 'good' or 'very good' in 96.6% of patients and almost all favoured prescribing moxifloxacin in the future. Very few adverse events were reported with moxifloxacin (<0.4%), and were mostly gastrointestinal disturbances.
Conclusions: Moxifloxacin is a very effective and safe treatment for patients with acute sinusitis in general practice and is highly regarded by both physicians and patients because of rapid symptom improvement and good tolerability.

Acute respiratory tract infections (RTIs) acquired in the community are a common and persistent source of morbidity, disability and mortality, and account for around two-thirds of prescriptions for antibiotics for community-acquired infections.[1] Acute bacterial sinusitis has been estimated to affect up to 2% of the 252 million people per year who experience acute viral sinusitis in the US alone.[2,3] Other important RTIs, such as bacterial acute exacerbations of chronic bronchitis (AECB) and community-acquired pneumonia (CAP), are associated with significant mortality, particularly in the elderly.[4,5,6]

The treatment of RTIs in general practice requires effective empirical broad-spectrum antimicrobial therapy, with attention to the growing problem of emergent resistant strains of commonly encountered bacteria to commonly used antibiotics. In acute bacterial sinusitis, the organisms most frequently isolated in samples obtained by sinus aspiration are Streptococcus pneumoniae (31%) and Haemophilus influenzae (21%). Other pathogens include Gram-negative bacteria (9%), anaerobes (6%), Staphylococcus aureus (4%), Moraxella catarrhalis (2%), other streptococci including S. pyogenes (2%), and various anaerobic bacteria (6%) found in maxillary sinusitis of dental origin.[3] Although bacterial sinusitis is estimated to resolve spontaneously in approximately 47% of patients, empirical antibiotic therapy is usually indicated to avoid complications and to influence the course of disease in a beneficial way.[7] Amoxicillin, amoxi-cillin-clavulanic acid, cefpodoxime or cefuroxime axetil are recommended for patients with mild to moderate acute bacterial sinusitis, and who have had antibiotic therapy in the past 4–6 weeks. For patients who are β-lactam allergic or who have moderate disease and have had prior antibiotic therapy, the recommended therapy is with a fluoroquinolone (moxifloxacin, gatifloxacin or levofloxacin). Macrolides or cotrimoxazole may also be considered for β-lactam-allergic patients; however, bacteriological failure rates of 20–25% are possible.[7] Sinus specimen isolates of S. pneumoniae from three consecutive respiratory seasons in the US had susceptibility rates of only 51.6% for penicillin and 59.7% for macrolides.[8]

Moxifloxacin is an 8-methoxy fluoroquinolone with potent bactericidal activity against a wide range of pathogens and favourable pharmacokinetic properties.[9,10] It has a broad spectrum of activity against the most relevant pathogens commonly found in RTIs.[11,12,13,14,15,16,17,18] Moxifloxacin has demonstrated rapid bactericidal activity against both Gram-positive and Gram-negative organisms and a high degree of penetration into sinus mucosa and respiratory tract tissues.[19,20] The substance is also active against penicillin- and macrolide-resistant strains of S. pneumoniae and β-lactamase-producing Haemophilus strains, as well as against atypical pathogens.[21]

Moxifloxacin has demonstrated superior clinical outcomes compared with cefuroxime axetil and amoxicillin/clavulanic acid in patients with acute sinusitis, and shows a rapid onset of action. It is well tolerated and has a convenient administration schedule.[22,23] Moxifloxacin has been reported to provide improvement in symptoms within 3 days in patients with RTIs.[24,25,26,27,28,29,30,31,32,33,34,35] Furthermore, rapid bacteriological eradication has been reported with moxifloxacin, with an overall eradication rate of 96% reported at days 3–4 in one recent study examining treatment of acute maxillary sinusitis in patients with first-line antibiotic failure or with a high risk of complications.[36]

The aim of the present post-marketing surveillance (PMS) study was to investigate the efficacy and tolerability of moxifloxacin in RTIs. In this paper, we report the results for 2405 patients with acute sinusitis under routine treatment conditions.