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Table 3 Effect of ICS based therapies on the risk of COPD exacerbation

From: Pharmacological strategies to reduce exacerbation risk in COPD: a narrative review

Treatment [Reference]

Annual exacerbation rate

Comparator

Annual exacerbation rate

Reduction in exacerbations

Exacerbation endpoint

Patient population

Exacerbation entry criteria (No./year)

FEV1 % predicted

ICS

 FP [131]

0.93

Placebo

0.73

NS

Primary

NA

<90 % (post-BD)

 FP [13]

0.93

Placebo

1.13

18 %

Secondary (moderate or severe)

NA

<60 % (pre-BD)

 FP [65]

1.05

Placebo

1.30

19 %

Secondary (any)

≥1

25–70 % (pre-BD)

 FP [132]

0.99

Placebo

1.32

25 %

Secondary (any)

NA

<85 % (post-BD)

LABA/ICS

 SFC [133]

0.44

Salmeterol

0.48

NS

Primary (severe)

≥1 (last 14 days)

<70 % (pre-BD)

 SFC [134]

1.10

Salmeterol

1.59

30.4 %

Primary (moderate or severe)

≥1

<50 %

 SFC [13]

0.85

Placebo

Salmeterol

FP

1.13

0.97

0.93

25 %

12 %

9 %

Secondary (moderate or severe)

NA

<60 % (pre-BD)

 SFC [65]

0.97

Placebo

1.30

25 %

Secondary (moderate)

≥1

25–70 % (pre-BD)

 SFC [135]

1.06

Salmeterol

1.53

30.5 %

Primary

≥1

<50 %

 SFC [61, 136]

1.28

Tiotropium

1.32

NS

Primary (moderate or severe)

NA

<50 % (post-BD)

 SFC [137]

0.92

Salmeterol

1.4

35 %

Primary (moderate or severe)

≥2

<50 % (post-BD)

 Bud/Form [80]

1.38

Placebo

Formeterol

Budesonide

1.80

1.85

1.60

23.6 %

NS

NS

Primary (all)

≥1

<50 % (pre-BD)

 Bud/Form [81]

1.42

Placebo

Formoterol

Budesonide

1.87

1.84

1.59

24 %

23 %

NS

Primary (severe)

≥1

<50 %

 Bud/Form [138]

0.70 (320/9 μg)

0.79 (160/9 μg)

Formoterol

1.07

34.6 %

25.9 %

Primary (moderate or severe)

≥1

≤50 % (pre-BD)

 Bud/Form [139]

NR

Formoterol

NR

36 %

Secondary (any)

≥1

≤50 % (pre-BD)

 FF/VI [79]

0.81

Vilanterol

1.11

30 %(Pooled data)

Primary (moderate or severe)

≥1

<70 % (post-BD)

 BDP/FOR [140]

0.80

Formoterol

1.12

28 %

Primary (moderate or severe)

≥1

<50 %

 BDP/FOR [141]

0.41

Bud/Form Formoterol

0.42

0.43

NS

Primary

≥1

30–50 % (post-BD)

Triple therapy

 Tiotropium + salmeterol + FP [64]

1.37

Tiotropium

1.61

NS

Secondary (any)

≥1

<65 % (post-BD)

  1. Studies identified using PubMed search of key terms and limited to clinical trials published in English language and including at least 100 patients. Results were manually filtered for relevance and additional studies added at the author’s discretion. Reductions in exacerbations vs comparator were statistically significant unless otherwise stated (See Additional file 1 for detailed description of term used in searchs)
  2. BD bronchodilator, BDP/FOR beclomethasone dipropionate/formoterol fumarate, FP fluticasone propionate, ICS inhaled corticosteroid, IND/GLY indacaterol/glycopyrronium, LABA long-acting β2-agonist, SFC salmeterol/fluticasone propionate, Bud/Form budesonide formoterol, FF/VI fluticasone furoate/vilanterol, NA not applicable, NR not reported, NS not significant