PMID- 16469488 OWN - NLM STAT- MEDLINE DCOM- 20070612 LR - 20220409 IS - 0954-6111 (Print) IS - 0954-6111 (Linking) VI - 100 IP - 9 DP - 2006 Sep TI - Long-term moxifloxacin in complicated tuberculosis patients with adverse reactions or resistance to first line drugs. PG - 1566-72 AB - 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 In 4 (10.5%) patients the drug was withdrawn for major AEs; no irreversible or fatal events were recorded.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. FAU - Codecasa, Luigi Ruffo AU - Codecasa LR AD - TB Unit, Villa Marelli Inst., Niguarda Hospital, Regional Reference Centre for TB, Viale Zara 81, 20159 Milan, Italy. luigiruffo.codecasa@fastwebnet.it FAU - Ferrara, Giovanni AU - Ferrara G FAU - Ferrarese, Maurizio AU - Ferrarese M FAU - Morandi, Maria Antonietta AU - Morandi MA FAU - Penati, Valeria AU - Penati V FAU - Lacchini, Carla AU - Lacchini C FAU - Vaccarino, Patrizia AU - Vaccarino P FAU - Migliori, Giovanni Battista AU - Migliori GB LA - eng PT - Journal Article DEP - 20060215 PL - England TA - Respir Med JT - Respiratory medicine JID - 8908438 RN - 0 (Antitubercular Agents) RN - 0 (Aza Compounds) RN - 0 (Fluoroquinolones) RN - 0 (Quinolines) RN - U188XYD42P (Moxifloxacin) SB - IM MH - Adult MH - Antitubercular Agents/adverse effects/*therapeutic use MH - Aza Compounds/adverse effects/*therapeutic use MH - Drug Administration Schedule MH - Drug Resistance, Multiple, Bacterial/drug effects MH - Female MH - Fluoroquinolones MH - Humans MH - Italy MH - Male MH - Moxifloxacin MH - Quinolines/adverse effects/*therapeutic use MH - Treatment Outcome MH - Tuberculosis, Multidrug-Resistant/*drug therapy EDAT- 2006/02/14 09:00 MHDA- 2007/06/15 09:00 CRDT- 2006/02/14 09:00 PHST- 2005/09/24 00:00 [received] PHST- 2005/12/11 00:00 [revised] PHST- 2006/01/02 00:00 [accepted] PHST- 2006/02/14 09:00 [pubmed] PHST- 2007/06/15 09:00 [medline] PHST- 2006/02/14 09:00 [entrez] AID - S0954-6111(06)00007-2 [pii] AID - 10.1016/j.rmed.2006.01.002 [doi] PST - ppublish SO - Respir Med. 2006 Sep;100(9):1566-72. doi: 10.1016/j.rmed.2006.01.002. Epub 2006 Feb 15.