Abstract
Rationale: Many patients with chronic obstructive pulmonary disease (COPD) have an accelerated loss of lung function. It is unclear whether drug treatment can modify this in moderately severe disease.
Objectives: In a pre-specified analysis of the key secondary outcome in the Study to Understand Mortality and MorbidITy (SUMMIT), we investigated whether the inhaled corticosteroid fluticasone furoate 100 μg (FF), the long-acting beta-agonist vilanterol 25 µg (VI) or the combination (FF/VI) modified the rate of decline in FEV1 compared with placebo. We also investigated how baseline co-variates affected this decline.
Methods: Spirometry was measured every 12 weeks in this event-driven randomized, placebo controlled trial of 16,485 patients with moderate COPD and heightened cardiovascular risk. An average of 7 spirometry assessments per subject in the 15,457 patients with at least one on-treatment measurement were used in the rate of FEV1 decline analysis. All statistical comparisons are considered nominal.
Main results: The adjusted rate of FEV1 decline was -46 mL/year (-3.0% of baseline) with placebo, -47 mL/year (-3.1%) with VI, -38 mL/year (-2.5%) with FF and -38 mL/year (-2.3 %) with FF/VI. FF-containing regimes had lower rates of decline than placebo (p<0.03) and FF/VI had lower rate of decline than VI alone (p<0.005). The FEV1 decline was faster in current smokers, those with a lower body-mass index, males and patients with established cardiovascular disease.
Conclusions:
In patients with moderate COPD and heightened cardiovascular risk, FF alone or in combination with VI appears to reduce the rate of FEV1 decline.
Original language | English |
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Journal | American Journal of Respiratory and Critical Care Medicine |
Early online date | 24 Jul 2017 |
DOIs | |
Publication status | Published - 2017 |
Keywords
- COPD
- Cardiovascular disease
- Fluticasone Furoate
- Vilanterol
- combination therapy
- rate of decline in FEV1