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Table 2 Severe and moderate/severe exacerbations over 26 weeks of treatment following the 3-week stabilization period in the ITT population and patient subgroups

From: Fluticasone propionate/salmeterol 250/50 μg versus salmeterol 50 μg after chronic obstructive pulmonary disease exacerbation

  FP/SAL 250/50 μg (N = 314) SAL 50 μg (N = 325) Ratio FP/SAL:SAL (95% CI) PValue
Severe exacerbations, ITT population; n (%)
Patients having exacerbation 43 (14) 39 (12)   
Number of exacerbations 50 51   
Mean annualized exacerbation rate 0.44 0.48 0.92 (0.58, 1.45) .710
Moderate/severe exacerbations, ITT population; n (%)
Patients having exacerbation 102 (32) 115 (35)   
Number of exacerbations 156 182   
Mean annualized exacerbation rate 1.49 1.81 0.82 (0.64, 1.06) .136
Moderate/severe exacerbations, patient subgroups; n (%)
Baseline post-bronchodilator % predicted FEV1≥ 30% and prior ICS use
n 180 193   
Patients having exacerbation 49 (27) 66 (34)   
Number of exacerbations 74 106   
Mean annualized exacerbation rate 1.54 2.28 0.68 (0.47, 0.97) NA
Baseline post-bronchodilator % predicted FEV1≥ 30% and no prior ICS use
n 60 66   
Patients having exacerbation 21 (35) 24 (36)   
Number of exacerbations 38 34   
Mean annualized exacerbation rate 1.07 0.91 1.18 (0.69, 2.00) NA
Baseline post-bronchodilator % predicted FEV1≥ 30% and concurrent tiotropium use
n 88 95   
Patients having exacerbation 28 (32) 32 (34)   
Exacerbations 40 56   
Mean annualized exacerbation rate 1.00 1.48 0.67 (0.41, 1.11) NA
Baseline post-bronchodilator % predicted FEV1≥ 30% and no concurrent tiotropium use
n 152 164   
Patients having exacerbation 42 (28) 58 (35)   
Number of exacerbations 72 84   
Mean annualized exacerbation rate 1.88 2.22 0.85 (0.58, 1.24) NA
Baseline post-bronchodilator % predicted FEV1< 30%
n 72 65   
Patients using concurrent tiotropium 33 (46) 30 (46)   
Patients having exacerbation 31 (43) 25 (38)   
Number of exacerbations 43 42   
Mean annualized exacerbation rate 2.78 2.84 0.98 (0.61, 1.57) NA
  1. Annualized rate estimates, ratio, CI and P-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity and time on treatment. CI = confidence interval; FEV1= forced expiratory volume in 1 second; FP = fluticasone propionate; ICS = inhaled corticosteroid; ITT = intent-to-treat; NA = not applicable; SAL = salmeterol.