Umeclidinium/vilanterol outperforms monotherapies in COPD

Aug 13 2014

By Lucy Piper, Senior medwireNews Reporter

A combination of umeclidinium (UMEC) and vilanterol (VI) is more effective than each drug as monotherapy for the treatment of chronic obstructive pulmonary disease (COPD), research indicates.

The results also suggest that the long-acting muscarinic antagonist/β₂-agonist combination UMEC/VI 62.5/25 µg has a similar tolerability and safety profile over 24 weeks to that of UMEC 62.5 µg and VI 25 µg when given individually.

“The study findings confirm the rationale for the development of a combination long-acting bronchodilator therapy utilising medications with distinct and complementary mechanisms of action,” say lead researcher James Donohue (University of North Carolina College of Medicine, Chapel Hill, USA) and colleagues.

They add that the “convenience of a once-daily dosing regimen further supports UMEC/VI 62.5/25 [µg] as a maintenance treatment for COPD.”

The researchers found that for 413 patients with COPD treated with UMEC/VI 62.5/25 µg via dry powder inhaler, trough forced expiratory volume in one second (FEV₁) improved by 0.167 L compared with placebo-treated patients.

UMEC and VI monotherapies, taken by 418 and 421 patients, respectively, also outperformed placebo with regard to improvements in trough FEV₁, but the increases with combined treatment were significantly superior to both monotherapies at day 168, at between 0.052 L and 0.095 L.

Combined UMEC/VI was also associated with a 0.242 L greater increase in 0–6 h weighted mean FEV₁ between baseline and day 168, compared with placebo. And increases were 0.092 L and 0.120 L greater when compared with UMEC and VI monotherapies.

“Overall, the lung function findings demonstrate that both UMEC 62.5 [µg] and VI 25 [µg] are efficacious compared with placebo and that both contribute to the bronchodilator efficacy of UMEC/VI 62.5/25 [µg] over the entire 24-h dosing interval, showing that both are effective bronchodilators suitable for once-daily dosing”, the researchers report.

The benefits of UMEC/VI also extended to other symptom and health-related quality of life measures “that were noticeable to the study participants”, says the team. It improved dyspnoea throughout the study compared with placebo, with differences in Transition Dyspnoea Index score exceeding the minimum clinically important difference of 1.0 unit.

This finding was consistent with superior improvements in patients’ ability to carry out daily activities, as measured on the Shortness of Breath with Daily Activity questionnaire and the St. George’s Respiratory Questionnaire and the fact that patients taking UMEC/VI needed 0.8 fewer puffs per day of rescue salbutamol than those taking placebo.

The researchers also note in Respiratory Medicine that adverse effects associated with higher doses of long-acting β₂-agonists, such as tremor, blood pressure changes, tachycardia, arrhythmias and palpitations were no more likely to occur with UMEC/VI treatment than with placebo.

Indeed, the incidence of treatment-related adverse events was similar across treatment groups, and serious adverse events and events leading to withdrawal were infrequent.

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