On-treatment adjudicated first cardiovascular event | Placebo n=4111 | Fluticasone furoate n=4135 | Vilanterol n=4118 | Combination therapy n=4121 |
Patients with composite cardiovascular outcome | 173 (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 1 | 33 | 38 | 36 | 39 |
Type 2 | 5 | 6 | 3 | 6 |
Other/indeterminate | 0 | 1 | 5 | 1 |
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%) |
Ischaemic | 24 | 29 | 20 | 24 |
Haemorrhagic | 6 | 3 | 8 | 4 |
Indeterminate | 3 | 1 | 2 | 3 |
Transient ischaemic attack | 8 (0.2%) | 7 (0.2%) | 12 (0.3%) | 7 (0.2%) |
Sudden death | 62 (1.5%) | 53 (1.3%) | 62 (1.5%) | 63 (1.5%) |
Cardiac surgery death | 1 (<0.1%) | 1 (<0.1%) | 0 | 0 |
Other cardiovascular death | 5 (0.1%) | 6 (0.1%) | 10 (0.2%) | 8 (0.2%) |
Heart failure | 2 | 5 | 4 | 5 |
Peripheral vascular disease | 3 | 1 | 5 | 3 |
Heart valve | 0 | 0 | 1 | 0 |
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.