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. .

View Anoro Ellipta drug record

Further information: GlaxoSmithKline


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