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Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium

W. Vincken, J.A. van Noord, A.P.M. Greefhorst, Th.A. Bantje, S. Kesten, L. Korducki, P.J.G. Cornelissen
European Respiratory Journal 2002 19: 209-216; DOI: 10.1183/09031936.02.00238702
W. Vincken
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J.A. van Noord
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A.P.M. Greefhorst
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Th.A. Bantje
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S. Kesten
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L. Korducki
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P.J.G. Cornelissen
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  • Article
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  • Fig. 1.—
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    Fig. 1.—

    Mean forced expiratory volume in one second (FEV1) before and during the 3 h following inhalation of tiotropium (▴) or ipratropium (□) at baseline (day 1, –––– ) and after 8 (- - - - -) and 364 (– – –) days.

  • Fig. 2.—
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    Fig. 2.—

    Mean change (Δ) in trough forced expiratory volume in one second (FEV1) following inhalation of tiotropium (▴) or ipratropium (□) at baseline (═) and throughout the 1-yr trials (p<0.001 at all time points).

  • Fig. 3.—
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    Fig. 3.—

    a) Mean Transition Dyspnoea Index (TDI) focal score over 1 yr for the tiotropium (▴) and ipratropium (□) groups. b) Proportion of patients with an increase (improvement) TDI focal score of ≥1 unit for the tiotropium (Embedded Image) and ipratropium (□) groups during the 1-yr study. *: p<0.05; **: p<0.01; ***: p<0.001.

  • Fig. 4.—
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    Fig. 4.—

    a) Mean St George's Respiratory Questionnaire (SGRQ) total score over 1 yr for the tiotropium (▴) and ipratropium (□) groups (═: baseline). b) Proportion of patients with an improvement in SGRQ total score of ≥4 units for the tiotropium (Embedded Image) and ipratropium (□) groups during the 1-yr study. *: p<0.05; **: p<0.001.

  • Fig. 5.—
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    Fig. 5.—

    Kaplan-Meier estimates of the probability of: a) no exacerbation (p=0.008 for time to first exacerbation); and b) no hospitalization (p=0.048 for time to first hospitalization) due to a chronic obstructive pulmonary disease exacerbation for the tiotropium (––––) and ipratropium (═) groups during the 1-yr study.

Tables

  • Figures
  • Table 1—

    Patients randomized and reason for withdrawal from the tiotropium and ipratropium groups

    Tiotropium n (%)Ipratropium n (%)
    Randomized356 (100)179 (100)
    Completed trial302 (84.8)141 (78.8)
    Withdrawn due to adverse events36 (10.1)23 (12.8)
    Worsening of COPD11 (3.1)11 (6.1)
    Worsening of other pre-existing disease2 (0.6)4 (2.2)
    Other adverse event23 (6.5)8 (4.5)
    Withdrawn due to lack of efficacy3 (0.8)3 (1.7)
    Withdrawn for other reasons15 (4.2)12 (6.7)
    Noncompliant with protocol3 (0.8)3 (1.7)
    Lost to follow-up2 (0.6)0 (0.0)
    Consent withdrawn5 (1.4)4 (2.2)
    Miscellaneous5 (1.4)5 (2.8)
    • COPD: chronic obstructive pulmonary disease

  • Table 2—

    Demographic data and previous respiratory medication use on screening for the tiotropium and ipratropium groups

    TiotropiumIpratropium
    Subjects n356179
    Age yrs63.6±8.264.5±8.1
    Sex male/femal %84/1686/14
    Duration of COPD yrs11.4±9.911.2±9.6
    Smoking pack-yrs34.3±18.633.2±16.7
    FEV1 L1.25±0.431.18±0.37
    FEV1 % pred41.9±12.739.4±10.7
    FVC L2.76±0.822.62±0.74
    FEV1/FVC %45.7±10.445.5±10.0
    Respiratory medication use n (%)
     Any pulmonary medication346 (97.2)172 (96.1)
     Anticholinergic218 (61.2)106 (59.2)
     β-Adrenergics (inhaled)272 (76.4)135 (75.4)
     β-Adrenergics (oral)18 (5.1)8 (4.5)
     Steroid (inhaled)286 (80.3)145 (81.0)
     Steroid (oral)31 (8.7)19 (10.6)
     Theophylline58 (16.3)27 (15.1)
    • Data are presented as mean±sd or n (%)

    • COPD: chronic obstructive pulmonary disease

    • FEV1: forced expiratory volume in one second

    • FVC: forced vital capacity

    • % pred: percentage of the predicted value

  • Table 3—

    St George's Respiratory Questionnaire (SGRQ), Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Transition Dyspnea Index (TDI) focal score results at the end of the trial in the ipratropium and tiotropium groups

    IpratropiumTiotropiumDifference95% CIp-value
    SGRQ
     Symptoms50.47±1.4947.32±1.07−3.15±1.73−6.55–0.260.070
     Activities56.21±1.1755.07±0.84−1.14±1.36−3.82–1.530.401
     Impacts35.23±1.1430.95±0.81−4.28±1.32−6.87–−1.680.001
     Total44.20±0.9740.90±0.69−3.30±1.13−5.51–−1.090.004
    SF-36
     Physical function52.20±1.4054.32±1.002.11±1.62−1.08–5.300.194
     Role physical49.46±2.8856.62±2.057.16±3.340.59–13.730.033
     Bodily pain76.57±1.6979.47±1.212.89±1.96−0.96–6.750.141
     General physical health47.01±1.2949.89±0.922.88±1.50−0.06–5.820.055
     Physical health summary38.49±0.5940.16±0.421.68±0.690.33–3.020.015
     Vitality57.56±1.2560.35±0.892.79±1.45−0.06–5.640.055
     Social function74.68±1.7576.07±1.251.39±2.02−2.59–5.370.493
     Role emotional63.86±2.9570.29±2.106.44±3.42−0.28–13.150.060
     General mental health75.40±1.1776.12±0.840.71±1.36−1.96–3.390.600
     Mental health summary50.90±0.7051.82±0.500.93±0.82−0.68–2.530.258
    TDI
     Focal score−0.44±0.230.46±0.160.90±0.260.37–1.410.001
    • Data are presented as mean±sem or range

    • CI: confidence interval

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Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium
W. Vincken, J.A. van Noord, A.P.M. Greefhorst, Th.A. Bantje, S. Kesten, L. Korducki, P.J.G. Cornelissen
European Respiratory Journal Feb 2002, 19 (2) 209-216; DOI: 10.1183/09031936.02.00238702

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Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium
W. Vincken, J.A. van Noord, A.P.M. Greefhorst, Th.A. Bantje, S. Kesten, L. Korducki, P.J.G. Cornelissen
European Respiratory Journal Feb 2002, 19 (2) 209-216; DOI: 10.1183/09031936.02.00238702
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