In Depth | Anoro Ellipta: first LABA/LAMA combination inhaler for COPD

Anoro Ellipta (vilanterol/umeclidinium) is a dry powder inhaler licensed for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD).

NICE recommends considering a LAMA in addition to a LABA if an inhaled corticosteroid is declined or not tolerated.
NICE recommends considering a LAMA in addition to a LABA if an inhaled corticosteroid is declined or not tolerated.

PHARMACOLOGY

Vilanterol is a long-acting beta2 agonist (LABA). Its bronchodilatory action is complemented by that of umeclidinium, a long-acting muscarinic receptor antagonist (LAMA) which exerts its effects by competitively inhibiting the binding of acetylcholine to muscarinic receptors on airway smooth muscle.1 

CLINICAL STUDIES

The clinical efficacy of once-daily vilanterol/umeclidinium was evaluated in eight phase III studies involving 6,835 adults with COPD.1

Lung function

In one six-month study (n=1,532) significant improvements in lung function (as defined by change from baseline in trough FEV1) at week 24 were observed for vilanterol/umeclidinium compared with placebo (p<0.001) and with each monotherapy treatment arm (p<0.001 vs vilanterol, p=0.004 vs umeclidinium).1

Vilanterol/umeclidinium was also shown to produce significantly greater improvements in lung function than tiotropium in two of three six-month active comparator studies (n=905, p<0.001 and n=410, p<0.001) and numerically greater improvements in the third (n=432, p=0.018).1

Breathlessness

At week 24, a clinically meaningful increase in transition dyspnoea index (TDI) focal score (key secondary endpoint) was observed with vilanterol/umeclidinium compared with placebo (p<0.001).1  

Quality of life

Improvements relating to health-related quality of life were also observed for vilanterol/umeclidinium in clinical studies. In one of the three comparator studies, the combination was associated with a statistically significant reduction in total score on the St. George’s Respiratory Questionnaire compared with tiotropium monotherapy.1 

Rescue medication

Three six-month trials (total n=1747) showed that vilanterol/umeclidinium reduced the use of rescue medication compared with tiotropium. Similar outcomes were also observed with placebo and umeclidinium montherapy.1

COPD exacerbations

COPD exacerbations were reduced by 50% with vilanterol/umeclidinium compared with placebo (HR 0.5, p=0.004), by 20% compared with umeclidinium (HR 0.8, p=0.391) and by 30% compared with vilanterol (HR 0.7, p=0.121).1

Safety

The most frequently reported adverse effect in patients receiving vilanterol/umeclidinium was nasopharyngitis. Other commonly reported adverse effects included UTI, sinusitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation and dry mouth.1

References

  1. Anoro Ellipta Summary of Product Characteristics, May 2014.

View Anoro Ellipta drug record

Further information: GlaxoSmithKline

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