Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial

摘要: Abstract Rationale Pneumonia risk with inhaled corticosteroid use in chronic obstructive pulmonary disease (COPD) has not been thoroughly assessed patients moderate airflow limitation. Objectives To determine the incidence of pneumonia and factors COPD limitation who had, or were at high for cardiovascular disease. Methods In Study to Understand Mortality MorbidITy (SUMMIT), 16,590 subjects (50% ≤ FEV 1  ≤ 70% predicted) heightened randomized double-blind 1:1:1:1 once-daily vilanterol 25 μg (VI), fluticasone furoate 100 μg (FF), combined (FF/VI), matched placebo. a pre-specified analysis, we investigator-reported adverse events, independently-adjudicated fatal events. Measurements main results The safety population comprised 16,568 actually received study medication. There 1017 events reported from 842 subjects. For placebo, FF, VI FF/VI, was 5%, 4% 6%, respectively. When adjusted time on treatment, event rates similar FF FF/VI containing arms (3.84, 4.24 3.95/100 treatment years, respectively) but lower group (2.77/100 years). Risk included: greater degree (i.e. FEV 2 . Conclusions contrast previous studies severe disease, increased evident risk.