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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.