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

G. B. Migliori, B. Eker, M. D. Richardson, G. Sotgiu, J-P. Zellweger, A. Skrahina, J. Ortmann, E. Girardi, H. Hoffmann, G. Besozzi, N. Bevilacqua, D. Kirsten, R. Centis, C. Lange
European Respiratory Journal 2009 34: 387-393; DOI: 10.1183/09031936.00009509
G. B. Migliori
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B. Eker
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M. D. Richardson
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G. Sotgiu
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J-P. Zellweger
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A. Skrahina
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J. Ortmann
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E. Girardi
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H. Hoffmann
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G. Besozzi
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N. Bevilacqua
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D. Kirsten
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R. Centis
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C. Lange
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    Fig. 1—

    Frequency of adverse effects attributed to linezolid during combined treatment against multidrug-resistant/extensively drug-resistant tuberculosis at different time-points after treatment initiation with a 600 mg q.d. or a 600 mg b.i.d. regimen (denominator is the total number of individuals per group). □: 600 mg q.d., n = 28; ▓: 600 mg b.i.d., n = 57.

Tables

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  • Table 1—

    Safety and tolerability of linezolid in patients treated for multidrug-resistant/extensively drug-resistant tuberculosis in Belarus, Germany, Italy and Switzerland, 2001–2007

    Total600 mg q.d.600 mg b.i.d.p-value#
    Patients
     Total n852857
     No adverse event50 (58.8)24 (85.7)26 (45.6)0.0004
     Any adverse event35 (41.2)4 (14.3)31 (54.4)0.0004
      Minor8 (9.4)08 (14)
      Major27 (31.8)4 (14.3)23 (40.4)0.01
    Episodes
     Total n52547
     Anaemia23 (44.2)3 (60)20 (42.5)0.44
     Thrombocytopenia7 (13.5)0 (0)7 (14.9)
     Nausea/vomiting4 (7.7)1 (20)3 (6.4)0.25
     Polyneuropathy3 (5.8)1 (20)2 (4.3)0.13
     Others15 (28.8)0 (0)15 (31.9)
    • Data are presented as n (%), unless otherwise stated. #: comparison between 600 mg q.d. group and 600 mg b.i.d. group.

  • Table 2—

    Comparison of efficacy end-points for the treatment of multidrug-resistant/extensively drug-resistant tuberculosis with or without linezolid in cases with known outcome

    LinezolidNo linezolidp-value
    Patients n45110
    Sputum smear conversion time days
     Mean±sd102.9±7465.4±80.10.007
     n (%)31 (69)59 (54)
    Culture conversion time days
     Mean±sd109±7169±630.0007
     n (%)39 (87)86 (78)
    Treatment outcome
     Success36 (80.0)90 (81.8)0.88
      Cured23 (51.1)75 (68.2)0.04
      Completed13 (28.9)15 (13.6)0.02
     Failure1 (0.9)
     Death9 (20)19 (17.3)0.65
    • Data are presented as n (%), unless otherwise stated.

  • Table 3—

    Proportion of converters, according to the number of antituberculous drugs to which isolates were resistant, among patients treated with and without linezolid(LZD) in Belarus, Germany, Italy and Switzerland, 2001–2007

    Drug resistance nSputum smear conversionCulture conversion
    LZD treatedNo LZDp-valueLZD treatedNo LZDp-value
    <56/9 (66.7)35/59 (59.3)0.688/9 (88.9)50/59 (84.7)0.75
    5–716/26 (61.5)23/43 (53.5)0.5122/26 (84.6)34/43 (79.1)0.6
    >79/10 (90)1/8 (12.5)0.00099/10 (90)2/8 (25)0.004
    Total31/45 (68.9)59/110 (53.6)0.0739/45 (86.7)86/110 (78.2)0.22
    • Data are presented as n/n (%), unless otherwise stated.

  • Table 4—

    Logistic regression analysis of potential independent variables associated with adverse treatment outcome(failure or death) in multidrug-resistant/extensively drug-resistant tuberculosis (XDR-TB) cases

    VariablesCrude odds ratiop-valueAdjusted odds ratiop-value
    Sex male1.11 (0.43–2.85)0.821.8 (0.56–5.78)0.32
    Increasing age yrs1.03 (1.008–1.06)0.011.03 (1.003–1.07)0.03
    Previous treatment >30 days1.8 (0.76–4.27)0.181.01 (0.38–2.65)0.98
    Resistance to >5 drugs2.67 (1.17–6.1)0.011.78 (0.59–5.34)0.29
    Linezolid treatment0.88 (0.36–2.13)0.791.1 (0.39–3.1)0.85
    XDR-TB11.6 (3.2–42.05)<0.00018.3 (1.74–40.28)0.008
    • Data are presented as odds ratio (95% confidence interval), unless otherwise stated.

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A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis
G. B. Migliori, B. Eker, M. D. Richardson, G. Sotgiu, J-P. Zellweger, A. Skrahina, J. Ortmann, E. Girardi, H. Hoffmann, G. Besozzi, N. Bevilacqua, D. Kirsten, R. Centis, C. Lange
European Respiratory Journal Aug 2009, 34 (2) 387-393; DOI: 10.1183/09031936.00009509

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A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis
G. B. Migliori, B. Eker, M. D. Richardson, G. Sotgiu, J-P. Zellweger, A. Skrahina, J. Ortmann, E. Girardi, H. Hoffmann, G. Besozzi, N. Bevilacqua, D. Kirsten, R. Centis, C. Lange
European Respiratory Journal Aug 2009, 34 (2) 387-393; DOI: 10.1183/09031936.00009509
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