Placebo | FF | VI | FF/VI | p-value# | |
Mortality | 275 (6.7%) | 251 (6.1%) | 265 (6.4%) | 246 (6.0%) | 0.137 |
FEV1 decline mL·year−1 mean±se | 46±2.5 | 38±2.4 | 47±2.4 | 38±2.4 | 0.019 |
Cardiovascular endpoint¶ | 173 (4.2%) | 161 (3.9%) | 180 (4.4%) | 174 (4.2%) | 0.478 |
Moderate and severe exacerbations per year | 0.35 | 0.31 | 0.31 | 0.25 | <0.0001 |
Severe exacerbations per year | 0.07 | 0.06 | 0.06 | 0.05 | 0.0004 |
Pneumonia cases per 100 person-years | 3.8 | 4.2 | 2.8 | 3.9 | >0.05 |
SUMMIT: Study to Understand Mortality and Morbidity in COPD; FF: fluticasone furoate; VI: vilanterol; FEV1: forced expiratory volume in 1 s. #: FF/VI compared to placebo; ¶: on-treatment cardiovascular death, myocardial infarction, stroke, unstable angina and transient ischaemic attack.