Table 2

Number of patients with adjudicated cardiovascular events in treatment groups*

On-treatment adjudicated first cardiovascular eventPlacebo
n=4111
Fluticasone furoate
n=4135
Vilanterol
n=4118
Combination therapy
n=4121
Patients with composite cardiovascular outcome173 (4.2%)161 (3.9%)180 (4.4%)174 (4.2%)
Myocardial infarction 38 (0.9%)45 (1.1%)44 (1.1%)46 (1.1%)
 Type 133383639
 Type 25636
 Other/indeterminate0151
Unstable angina 26 (0.6%)16 (0.4%)22 (0.5%)19 (0.5%)
Stroke 33 (0.8%)33 (0.8%)30 (0.7%)31 (0.8%)
 Ischaemic24292024
 Haemorrhagic6384
 Indeterminate3123
Transient ischaemic attack8 (0.2%)7 (0.2%)12 (0.3%)7 (0.2%)
Sudden death62 (1.5%)53 (1.3%)62 (1.5%)63 (1.5%)
Cardiac surgery death1 (<0.1%)1 (<0.1%)00
Other cardiovascular death5 (0.1%)6 (0.1%)10 (0.2%)8 (0.2%)
 Heart failure2545
 Peripheral vascular disease3153
 Heart valve0010
  • Data are number of patients (%).

  • *There was no statistically significant difference in the number of patients with a composite cardiovascular event between treatment groups.

  • †Events may be fatal or non-fatal. Note that these are the first cardiovascular (CV) event—patients may have gone on to experience another CV event later.