RT Journal Article
SR Electronic
T1 A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 387
OP 393
DO 10.1183/09031936.00009509
VO 34
IS 2
A1 G. B. Migliori
A1 B. Eker
A1 M. D. Richardson
A1 G. Sotgiu
A1 J-P. Zellweger
A1 A. Skrahina
A1 J. Ortmann
A1 E. Girardi
A1 H. Hoffmann
A1 G. Besozzi
A1 N. Bevilacqua
A1 D. Kirsten
A1 R. Centis
A1 C. Lange
A1 for the TBNET Study Group
YR 2009
UL http://erj.ersjournals.com/content/34/2/387.abstract
AB Linezolid is used to treat patients with multidrug-resistant (MDR)/extensively drug-resistant (XDR)-tuberculosis (TB) cases, although clinical data on its safety, tolerability and efficacy are lacking. We performed a retrospective, nonrandomised, unblinded observational study evaluating the safety and tolerability of linezolid at 600 mg q.d. or b.i.d. in MDR/XDR-TB treatment in four European countries. Efficacy evaluation compared end-points of 45 linezolid-treated against 110 linezolid-nontreated cases. Out of 195 MDR/XDR-TB patients, 85 were treated with linezolid for a mean of 221 days. Of these, 35 (41.2%) out of 85 experienced major side-effects attributed to linezolid (anaemia, thrombocytopenia and/or polyneuropathy), requiring discontinuation in 27 (77%) cases. Most side-effects occurred after 60 days of treatment. Twice-daily administration produced more major side-effects than once-daily dosing (p = 0.0004), with no difference in efficacy found. Outcomes were similar in patients treated with/without linezolid (p = 0.8), although linezolid-treated cases had more first-line (p = 0.002) and second-line (p = 0.02) drug resistance and a higher number of previous treatment regimens (4.5 versus 2.3; p = 0.07). Linezolid 600 mg q.d. added to an individualised multidrug regimen may improve the chance of bacteriological conversion, providing a better chance of treatment success in only the most complicated MDR/XDR-TB cases. Its safety profile does not warrant use in cases for which there are other, safer, alternatives.