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. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01313676.
|Journal||American Journal of Respiratory and Critical Care Medicine|
|Early online date||24 Jul 2017|
|Publication status||E-pub ahead of print - 24 Jul 2017|
- Journal Article