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Table 4 On-treatment MACE (ITT population)

From: Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial

 

FF/UMEC/VI

(N = 4151)

FF/VI

(N = 4134)

UMEC/VI

(N = 2070)

Total duration at risk (patient-years)

3714.9

3457.9

1698.3

 

n (%)

Rate [#]

n (%)

Rate [#]

n (%)

Rate [#]

Narrow definition

Any MACE

80 (2)

22.3 [83]

60 (1)

18.8 [65]

37 (2)

22.4 [38]

 Adjudicated CV death

20 (< 1)

5.4 [20]

27 (< 1)

7.8 [27]

16 (< 1)

9.4 [16]

 Non-fatal CNS hemorrhages and cerebrovascular conditions (SMQ)

38 (< 1)

10.8 [40]

21 (< 1)

7.2 [25]

10 (< 1)

5.9 [10]

 Non-fatal MI (PT)

9 (< 1)

2.4 [9]

6 (< 1)

1.7 [6]

5 (< 1)

2.9 [5]

 Non-fatal acute MI (PT)

13 (< 1)

3.8 [14]

7 (< 1)

2.0 [7]

7 (< 1)

4.1 [7]

Broad definition

Any MACE

133 (3)

44.7 [166]

100 (2)

35.3 [122]

66 (3)

44.8 [76]

 Adjudicated CV death

20 (< 1)

5.4 [20]

27 (< 1)

7.8 [27]

16 (< 1)

9.4 [16]

 Non-fatal CNS hemorrhages and cerebrovascular conditions (SMQ)

38 (< 1)

10.8 [40]

21 (< 1)

7.2 [25]

10 (< 1)

5.9 [10]

 Non-fatal MI (SMQ)

49 (1)

14.0 [52]

29 (< 1)

9.3 [32]

24 (1)

14.7 [25]

 Non-fatal other ischemic heart disease (SMQ)

41 (< 1)

14.5 [54]

32 (< 1)

11.0 [38]

25 (1)

14.7 [25]

  1. #, number of events. Rates are reported as number of events per 1000 patient-years, calculated as the number of events × 1000, divided by the total duration at risk
  2. CNS Central nervous system; CV Cardiovascular; FF Fluticasone furoate; ITT Intent-to-treat; MACE Major adverse cardiac event; MedDRA Medical Dictionary for Regulatory Activities; MI Myocardial infarction; n, number of patients; PT Preferred Term; SMQ Standardized MedDRA Query; UMEC Umeclidinium; VI Vilanterol