Figures
- 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.—
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.—
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 (
) and ipratropium (□) groups during the 1-yr study. *: p<0.05; **: p<0.01; ***: p<0.001. - 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 (
) and ipratropium (□) groups during the 1-yr study. *: p<0.05; **: p<0.001. - 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
- Table 1—
Patients randomized and reason for withdrawal from the tiotropium and ipratropium groups
Tiotropium n (%) Ipratropium n (%) Randomized 356 (100) 179 (100) Completed trial 302 (84.8) 141 (78.8) Withdrawn due to adverse events 36 (10.1) 23 (12.8) Worsening of COPD 11 (3.1) 11 (6.1) Worsening of other pre-existing disease 2 (0.6) 4 (2.2) Other adverse event 23 (6.5) 8 (4.5) Withdrawn due to lack of efficacy 3 (0.8) 3 (1.7) Withdrawn for other reasons 15 (4.2) 12 (6.7) Noncompliant with protocol 3 (0.8) 3 (1.7) Lost to follow-up 2 (0.6) 0 (0.0) Consent withdrawn 5 (1.4) 4 (2.2) Miscellaneous 5 (1.4) 5 (2.8) -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
Tiotropium Ipratropium Subjects n 356 179 Age yrs 63.6±8.2 64.5±8.1 Sex male/femal % 84/16 86/14 Duration of COPD yrs 11.4±9.9 11.2±9.6 Smoking pack-yrs 34.3±18.6 33.2±16.7 FEV1 L 1.25±0.43 1.18±0.37 FEV1 % pred 41.9±12.7 39.4±10.7 FVC L 2.76±0.82 2.62±0.74 FEV1/FVC % 45.7±10.4 45.5±10.0 Respiratory medication use n (%) Any pulmonary medication 346 (97.2) 172 (96.1) Anticholinergic 218 (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) Theophylline 58 (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
Ipratropium Tiotropium Difference 95% CI p-value SGRQ Symptoms 50.47±1.49 47.32±1.07 −3.15±1.73 −6.55–0.26 0.070 Activities 56.21±1.17 55.07±0.84 −1.14±1.36 −3.82–1.53 0.401 Impacts 35.23±1.14 30.95±0.81 −4.28±1.32 −6.87–−1.68 0.001 Total 44.20±0.97 40.90±0.69 −3.30±1.13 −5.51–−1.09 0.004 SF-36 Physical function 52.20±1.40 54.32±1.00 2.11±1.62 −1.08–5.30 0.194 Role physical 49.46±2.88 56.62±2.05 7.16±3.34 0.59–13.73 0.033 Bodily pain 76.57±1.69 79.47±1.21 2.89±1.96 −0.96–6.75 0.141 General physical health 47.01±1.29 49.89±0.92 2.88±1.50 −0.06–5.82 0.055 Physical health summary 38.49±0.59 40.16±0.42 1.68±0.69 0.33–3.02 0.015 Vitality 57.56±1.25 60.35±0.89 2.79±1.45 −0.06–5.64 0.055 Social function 74.68±1.75 76.07±1.25 1.39±2.02 −2.59–5.37 0.493 Role emotional 63.86±2.95 70.29±2.10 6.44±3.42 −0.28–13.15 0.060 General mental health 75.40±1.17 76.12±0.84 0.71±1.36 −1.96–3.39 0.600 Mental health summary 50.90±0.70 51.82±0.50 0.93±0.82 −0.68–2.53 0.258 TDI Focal score −0.44±0.23 0.46±0.16 0.90±0.26 0.37–1.41 0.001 -
Data are presented as mean±sem or range
-
CI: confidence interval
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