Umeclidinium/Vilanterol Efficacy Assessed in Elderly COPD Patients

Regarding safety, the characteristics were similar to placebo for all age groups
Regarding safety, the characteristics were similar to placebo for all age groups

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. 

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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."

For more information visit springer.com.