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Respir Med. 2006 Sep;100(9):1566-72. Epub 2006 Feb 15.

Long-term moxifloxacin in complicated tuberculosis patients with adverse reactions or resistance to first line drugs.

Author information

1
TB Unit, Villa Marelli Inst., Niguarda Hospital, Regional Reference Centre for TB, Viale Zara 81, 20159 Milan, Italy. luigiruffo.codecasa@fastwebnet.it

Abstract

STUDY OBJECTIVES:

To test safety and tolerability of long-term moxifloxacin in resistant tuberculosis (TB) patients and patients with intolerance to first line anti-TB drugs.

DESIGN:

Clinical evaluation of adverse events (AEs) during prolonged moxifloxacin treatment.

SETTING:

TB Unit of the Regional TB Reference Center, Villa Marelli Institute, Niguarda Ca'Granda Hospital, Milan, Italy

PATIENTS AND INTERVENTIONS:

Patients treated with moxifloxacin, 400 mg orally once daily for TB in the Villa Marelli Institute from January 2001 to December 2003 were enrolled.

RESULTS:

Thirty-eight patients were treated with moxifloxacin at the Villa Marelli Institute in the study period, for multidrug resistant (MDR) TB (14, 36.8%), for intolerance to first line anti-TB drugs (9, 23.7%), for combined resistance and intolerance to first line anti-TB drugs (12, 31.6%), other reasons (3, 7.9%). The mean duration of moxifloxacin treatment was 6.3 +/- 5.2 months. Twelve (31.6%) patients reported at least an AE due to moxifloxacin, mostly gastrointestinal (8, 21.0%), general (5, 13.2%) and central nervous system (3, 7.9%) AEs. In 4 (10.5%) patients the drug was withdrawn for major AEs; no irreversible or fatal events were recorded. Most of the patients (31, 81.6%) reported a treatment success, even if the success rate was lower in MDR TB patients (8/14, 51.7%).

CONCLUSIONS:

Despite the fact that a large proportion of patients experienced at least an AE due to moxifloxacin, the drug resulted safe in the long-term administration for complicated TB cases.

PMID:
16469488
DOI:
10.1016/j.rmed.2006.01.002
[Indexed for MEDLINE]
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