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


In this PMS study a total of 9036 patients were documented, of whom 2405 had acute sinusitis. 1022 (42.5%) patients with sinusitis were male and 1367 (56.8%) were female. Information regarding gender was missing for 16 patients. Nearly all patients (96.1%) were >20 years of age, with 13.9% aged ≥60 years. The majority of patients were of White/Caucasian ethnicity. An overview of patients' characteristics at baseline is presented in Table I . Male and female patients did not differ markedly in any demographic variable at baseline, the main differences being greater mean height and weight for male patients.

The severity of the current episode of sinusitis was rated by physicians as mild in 93 patients (3.9%), moderate in 1703 patients (70.8%), and severe in 602 patients (25.0%). For 19 patients no data on severity of infection was available. Approximately one-third of patients (32.8%) had at least one concomitant disease in addition to sinusitis. The most common category of concomitant disease was cardiovascular disease (11.2%), followed by other respiratory disorders (5.9%), musculoskeletal disorders (4.9%), and type 2 diabetes mellitus (4.5%); 9.8% of patients had multiple co-morbidities (≥2).

One hundred and eighty-seven of 2405 patients (7.8%) had received pretreatment with one or more antibiotic agents within the current bacterial infection. The most commonly used agents were macro-lides (2.4%), penicillin (2.2%) or tetracyclines (2.0%). Only nine patients received another anti-biotic concomitantly with moxifloxacin during the study period. Other medications taken by patients concomitantly were principally antitussives/expectorants (25.8% of patients), rhinological treatments (25.4%) and analgesics/antirheumatic agents (13.2%).

Moxifloxacin therapy was taken by 92.9% of patients (2233/2405) for either 5 days (46.2%) or 7 days (46.7%). A small proportion of patients (6.9%; 165/2405) were treated with moxifloxacin for 10 days. Patients with more severe sinusitis tended to receive moxifloxacin therapy for a longer period of time. The majority of patients (95.6%; 2299/2405) received the recommended 400mg dose of moxifloxacin once daily.

Two follow-up visits were attended by 53.1% of patients, and occurred after a mean of 5.7 ± 4.9 days and 9.6 ± 5.3 days, respectively. According to physicians' evaluations, at least 92% of patients with specific individual symptoms of sinusitis of at least mild severity experienced improvement in or complete relief from these symptoms between baseline and the follow-up visit (figure 2). Symptoms such as fever, cough, purulent sputum, nasal secretions and obstruction completely resolved for the majority of patients. Improvements were generally evident after only a few days; 71.6% of patients improved after 3 days' and 96.2% after 5 days' treatment with moxifloxacin. The mean time for patients to recovery was 6.3 ± 2.0 days, with the vast majority (89.5%) recovered by day 8 after the start of treatment and 97.3% recovered by day 10.

Course of individual sinusitis symptoms from baseline to last follow-up.

Physicians' general assessments of the efficacy of moxifloxacin treatment was 'very good' or 'good' in 96.6% of patients (figure 3). Patients' acceptance of moxifloxacin therapy was assessed by the physicians and rated as 'very good' in 76.1% and 'good' in 21.6% of patients; 95% of physicians stated that they would prescribe moxifloxacin again.

Physicians' general assessments of efficacy for moxifloxacin therapy in patients with sinusitis (n = 2405).

In nine patients (<0.4%) a total of 12 AEs were reported that had a possible or probable relationship to moxifloxacin treatment ( Table II ). In most patients (7/9) these symptoms were reversible and in one patient the outcome was improved. The most frequently reported AEs were gastrointestinal disturbances (diarrhoea, nausea, vomiting and abdominal pain). Only one patient, a 72-year-old woman, experienced serious adverse drug reactions during the PMS, which consisted of sensory disturbance, vertigo and tachycardia, and required hospitalisation. The outcome of this case was 'resolved'. Overall, the tolerability of moxifloxacin therapy was rated by physicians as 'very good' or 'good' in 97.5% of cases (figure 4). No death was reported during the study.

Physicians' general assessments of tolerability for moxifloxacin therapy in patients with sinusitis (n = 2405).