The risk for pneumonia does not increase with inhaled corticosteroid (ICS) use in patients with chronic obstructive pulmonary disease (COPD) with moderate airflow limitation and increased cardiovascular risk, according to study results published in Respiratory Medicine.
These findings are in contrast to results from studies that examined ICS use in patients with COPD who had severe disease, where the risk for pneumonia was increased.
SUMMIT (Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease; ClinicalTrial.gov identifier: NCT01313676) trial investigators randomly assigned more than 16,500 patients with moderate airflow limitation (defined as ≥50% forced expiratory volume in 1 second [FEV1] ≤70% predicted) and increased cardiovascular risk to either inhaled vilanterol, fluticasone furoate, vilanterol combined with fluticasone furoate, or matched placebo. Of 16,568 patients in the safety population who received medication, 842 patients experienced 1017 pneumonia events.
The rates of pneumonia were 5% for those receiving placebo or fluticasone furoate, 4% for vilanterol, and 6% for those receiving the combination of fluticasone furoate and vilanterol. When adjusted for time on medication, the event rates were similar for all groups except the vilanterol group (3.84, 4.24, 3.95 per 100 treatment years in the placebo, fluticasone furoate, and combination groups, respectively vs 2.77 per 100 treatment years in the vilanterol group).
The risk for a severe COPD exacerbation or serious pneumonia was reduced by 20.2% with fluticasone furoate/vilanterol and by 16.1% with vilanterol monotherapy compared with placebo. Risk factors for pneumonia included greater degree of airflow limitation, history of prior exacerbations, and body mass index <25 kg/m2.
The researchers concluded that based on these data, ICS-containing regimens are effective as maintenance therapy in patients with COPD, particularly patients with a history of exacerbations, and may decrease the rate of exacerbations and delay the time to first event.
Disclosures: The SUMMIT trial was funded by GlaxoSmithKline.
Crim C, Calverley PMA, Anderson JA, et al. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: the SUMMIT trial. Respir Med. 2017;131:27-34.