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Breo Ellipta Fails to Meet Primary Endpoint in Study

A reduction in mortality was not statistically significant in initial results

GlaxoSmithKline and Theravance have announced initial results from the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) for Breo Ellipta 100/25 mcg (fluticasone furoate/ vilanterol [FF/VI]). Breo Ellipta is indicated for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations.

The study involved 16,485 patients from 43 countries who had COPD with moderate airflow limitation (FEV1 50%–70% predicted) and either a history or increased risk of cardiovascular disease (CVD). It is a placebo-controlled, double-blind, randomized, parallel-group, multicenter trial. Patients were randomized 1:1:1:1 to one of four treatment groups: FF/VI 100/25 mcg, FF 100 mcg, VI  25 mcg, or placebo. All treatments were administered once daily via the Ellipta dry powder inhaler. All comparisons for the primary, secondary, and other endpoints were performed at the two-sided 5% level of significance.

For the primary endpoint of the study, the risk of dying on FF/VI 100/25 mcg was 12.2% lower than on placebo over the study period; this was not statistically significant (P = 0.137).

The study also analyzed additional COPD endpoints assessing the efficacy of FF/VI relative to placebo, which included FEV1 (post-bronchodilator), rate of moderate/severe exacerbations, time to first moderate/severe exacerbation, time to first severe (hospitalized) exacerbation, rate of severe (hospitalized) exacerbation, health-related quality of life (as measured by the St George’s Respiratory Questionnaire-COPD total score at 12 months), and health status as measured using the COPD Assessment Tool (CAT) at 12 months. Against these endpoints, FF/VI demonstrated an improvement compared to placebo with a nominal P value of less than 0.002 for each. As the primary endpoint was not met, statistical significance cannot be inferred from these results.

SUMMIT in COPD is the first prospective study that aims to understand the effect of respiratory treatments in patients with COPD and a history or risk of CVD.

COPD mortality is increasing and is the third leading cause of death globally. COPD often coexists with other chronic diseases, and epidemiological data suggest that CVD or its risk occurs in nearly half of all patients with COPD. CVD is the number one killer of mild-to-moderate COPD patients, and patients with both COPD and CVD or its risk were observed to have a mortality rate double that of COPD patients without CVD in studies of up to 15 years in duration.

Source: GSK; September 8, 2015.

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