Abstract | BACKGROUND: OBJECTIVE: To further investigate moxifloxacin's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study. METHODS: A total of 18,409 outpatients with suspected bacterial episodes of acute sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia of mild to moderate severity were enrolled at 3377 community practice sites. Patients with sinusitis or pneumonia received once-daily oral moxifloxacin 400 mg for 10 days; those with bronchitis received 5 days' treatment. At follow-up, within 48 hours after the end of treatment, adverse event information was collected. An external safety committee assessed possible cardiac-related events. Efficacy was also evaluated at follow-up via the degree of resolution of clinical signs and symptoms. RESULTS: Of 18,374 safety-valid patients, 17.7% experienced adverse events and 14.3% experienced drug-related adverse events. The most common drug-related adverse events were nausea (5.3%), diarrhea (2.2%), and dizziness (2.0%). There was no clinical evidence of increased risk of cardiac arrhythmias with moxifloxacin treatment. Of 17,137 patients included in the efficacy analysis, 92.9% overall experienced clinical cure or improvement (92.8% with sinusitis, 92.9% with bronchitis, 94.1% with pneumonia). CONCLUSIONS:
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Authors | Gerald A Faich, Joel Morganroth, Alan B Whitehouse, Jugroop S Brar, Peter Arcuri, Steven F Kowalsky, Daniel C Haverstock, Roger A Celesk, Deborah A Church |
Journal | The Annals of pharmacotherapy
(Ann Pharmacother)
Vol. 38
Issue 5
Pg. 749-54
(May 2004)
ISSN: 1060-0280 [Print] United States |
PMID | 15026565
(Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Aza Compounds
- Fluoroquinolones
- Quinolines
- Moxifloxacin
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Aza Compounds
(adverse effects, therapeutic use)
- Child
- Female
- Fluoroquinolones
- Humans
- Male
- Middle Aged
- Moxifloxacin
- Quinolines
(adverse effects, therapeutic use)
- Respiratory Tract Infections
(drug therapy)
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