Umeclidinium/Vilanterol Efficacy Assessed in Elderly COPD Patients
Umeclidinium/vilanterol provides clinically significant lung function benefits for both younger and older patients with chronic obstructive pulmonary disease (COPD) compared with placebo, according to a study published in the journal Drugs & Aging.
Study authors performed a post hoc pooled analysis of data from 10 trials to assess the safety and efficacy of umeclidinium/vilanterol in elderly symptomatic patients with COPD. Specifically, they evaluated the change from baseline in trough FEV1, proportion of FEV1 responders, and safety outcomes among patients aged <65, ≥65, and ≥75 years.
The intent-to-treat (ITT) populations included 2246 patients in the 12-week parallel-group, 1296 patients in the 24-week parallel-group, and 472 patients in the 12-week crossover analysis group. The placebo ITT populations included 528, 280, and 505 patients, respectively.
Results showed significant improvements in trough FEV1 in the umeclidinium/vilanterol group vs placebo in patients aged <65 or ≥65 years of age across all analyses and at all timepoints considered (P <.001). Among patients aged ≥75 years, a statistically significant difference was seen in both parallel study datasets with umeclidinium/vilanterol vs placebo at all timepoints (P <.001). While a significant difference in trough FEV1 was seen in the crossover analysis between the two arms in the ≥75-year group on day 2 (P <.001) and day 42 (P =.023), the difference was not statistically significant on day 84 (P =.064).
The proportion of FEV1 responders (≥100mL increase from baseline in trough FEV1) was also significantly higher in the umeclidinium/vilanterol group vs placebo regardless of age or analysis at all timepoints considered (P ≤.005). At day 84, the proportion of FEV1 responders were 61%, 58%, and 57% for patients aged <65, ≥65, and ≥75 years of age, respectively in the 12-week parallel-group analysis. In the 24-week parallel-group analysis, the proportion of FEV1 responders at day 169 was 56%, 55%, and 48%, respectively. In the 12-week crossover analysis, the proportion of responders at day 84 were 58% and 53% in patients aged <65 years and ≥65 years, respectively.
Regarding safety, the characteristics were similar to placebo for all age groups. Based on these findings, the authors stated, "These results indicate that dual bronchodilation with [umeclidinium/vilanterol] via the Ellipta dry powder inhaler could substantially benefit elderly patients with COPD."
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