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Efficacy and Tolerability of Moxifloxacin in Patients with Respiratory Tract Infections Treated in General Practice

Results of a Post-Marketing Surveillance Study

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Abstract

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.

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Acknowledgements

The authors would like to thank all the physicians who participated in this surveillance study. This research was funded in part by an unrestricted grant from Bayer, who, other than providing financial support, were not involved in any way with the design, execution, data analysis or manuscript preparation. Weiqiang Chen has previously received research funds from Bayer. Harald Landen is responsible for PMS studies at Bayer Healthcare.

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Authors and Affiliations

  1. Department of Respiratory Disease, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, 710032, P.R. China

    Weiqiang Chen,  Changgui Wu, Zhikui Li & Chongqing Bai

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  1. Weiqiang Chen
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  2. Changgui Wu
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  4. Chongqing Bai
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Correspondence to Changgui Wu.

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Chen, W., Wu, C., Li, Z. et al. Efficacy and Tolerability of Moxifloxacin in Patients with Respiratory Tract Infections Treated in General Practice. Clin. Drug Investig. 26, 501–509 (2006). https://doi.org/10.2165/00044011-200626090-00003

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  • DOI: https://doi.org/10.2165/00044011-200626090-00003

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