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This Article Full Text Full Text (PDF) All Versions of this Article: 34/2/387    most recent 09031936.00009509v1 Alert me when this article is cited Alert me if a correction is posted Permissions Request Permissions Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Google Scholar Articles by Migliori, G. B. PubMed PubMed Citation Articles by Migliori, G. B.

A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis

For author affiliations and additional participating members of the Tuberculosis Network European Trials Group (TBNET) Study Group, please see the Acknowledgements section.

CORRESPONDENCE: C. Lange, Tuberculosis Network European Trials Group (TBNET), Clinical Infectious Diseases, Research Center Borstel, Parkallee 35, 23845 Borstel, Germany. E-mail: clange{at}fz-borstel.de

Keywords: Efficacy, extensively drug-resistant tuberculosis, linezolid, multidrug-resistant tuberculosis, safety, tolerability

Received: January 20, 2009
Accepted February 24, 2009

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.

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				W.-J. Koh and T. S. Shim Daily 300 mg dose of linezolid for the treatment of intractable multidrug-resistant and extensively drug-resistant tuberculosis--authors' response J. Antimicrob. Chemother., November 1, 2009; 64(5): 1119 - 1120. [Full Text] [PDF]