Efficacy and tolerability of moxifloxacin in patients with respiratory tract infections treated in general practice: Results of a post-marketing surveillance study.

OBJECTIVE

This study aimed to assess the efficacy, safety and tolerability of oral moxifloxacin in patients with respiratory tract infections (RTIs) treated by attending physicians in routine clinical practice in China.

METHODS

This was an open-label, prospective, uncontrolled, post-marketing surveillance study that was undertaken between November 2002 and July 2003. Altogether, 855 patients with RTIs were treated with moxifloxacin. Data were collected by 257 physicians throughout China. Symptoms of RTI (fever, cough, purulent sputum, dyspnoea, thoracic pain, nasal obstruction, nasal secretion and headache), together with auscultatory findings, were assessed at baseline and at follow-up visits, and classified as 'absent', 'mild' or 'severe' by the attending physician.

RESULTS

Moxifloxacin produced significant improvements in 70.7% of patients after only 3 days of treatment. In 91.7% of patients, symptoms were improved after 5 days of treatment; 76.1% of patients recovered after 7 days and 84.7% recovered after 10 days of treatment. The mean +/- SD time until recovery was 5.1 +/- 2.6 days. Assessment of treatment efficacy by the physicians was 'good' or 'very good' for 89.2% of patients. In 87.3% of cases, physicians rated patients' acceptance of therapy with moxifloxacin as 'good' or 'very good'. The tolerability of moxifloxacin therapy was rated as 'good' or 'very good' for 88.8% of patients. Very few adverse events (4.1% of patients) were reported with moxifloxacin; most of them involved mild CNS disorders and gastrointestinal disturbances.

CONCLUSIONS

Moxifloxacin was shown to be an effective and well tolerated treatment for this group of patients with RTIs and was highly rated by both physicians and patients because of rapid symptom improvement and good tolerability.