Umeclidinium bromide and vilanterol trifenatate

(Anoro Ellipta®)

Anoro Ellipta®

Drug updated on 9/5/2024

Dosage FormPowder (oral Inhalation; 62.5 mcg umeclidinium and 25 mcg vilanterol)
Drug ClassAnticholinergics and long-acting beta2-adrenergic agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

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Summary
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  • Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • UMEC/VI demonstrated significant improvements in FEV1, ranking second highest in overall efficacy (SUCRA 93.5%) and showing the highest efficacy in trough FEV1 improvement (Emax 0.185 L).
  • UMEC/VI provided greater FEV1 improvement compared to monotherapies and placebo, with a 58% reduction in exacerbation risk.
  • UMEC/VI consistently improved SGRQ scores and TDI focal scores across various studies, with improvements comparable to or greater than other LAMA/LABA combinations.
  • UMEC/VI also reduced the need for rescue medication and demonstrated significant reductions in COPD exacerbations.
  • UMEC/VI significantly reduced the annualized rate of moderate/severe exacerbations and showed a 58% reduction in exacerbation risk compared to placebo.
  • The drug also exhibited a lower overall risk of exacerbations in a network meta-analysis compared to other LAMA/LABA combinations.
  • No significant differences were observed in all-cause mortality and serious adverse cardiovascular events among LABA/LAMA FDCs.
  • UMEC/VI demonstrated a similar safety profile to other LABA/LAMA combinations, showing no significant differences in major adverse cardiovascular events or pneumonia.
  • UMEC/VI was well-tolerated and safe in general COPD populations and across different medication subgroups, including maintenance-naïve and ICS-free patients.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate) Prescribing Information.2023GlaxoSmithKline, Research Triangle Park, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Network meta-analysis of the efficacy and safety of monoclonal antibodies and traditional conventional dichotomous agents for chronic obstructive pulmonary disease.2024Frontiers in Medicine
LABA/LAMA versus LABA/ICS fixed-dose combinations in the prevention of COPD exacerbations: a modeling analysis of literature aggregate data.2023European Journal of Clinical Pharmacology
Quantitative analysis of efficacy and safety of LABA/LAMA fixed-dose combinations in the treatment of stable COPD. 2022Therapeutic Advances in Respiratory Disease
Efficacy and safety of LAMA/LABA fixed-dose combination therapies in chronic obstructive pulmonary disease: a systematic review of direct and indirect treatment comparisons.2022International Journal of Chronic Obstructive Pulmonary Disease
Comparative Efficacy of Umeclidinium/Vilanterol Versus Other Bronchodilators for the Treatment of Chronic Obstructive Pulmonary Disease: A Network Meta-Analysis.2022Advances in Therapy
Comparisons of exacerbations and mortality among LAMA/LABA combinations in stable chronic obstructive pulmonary disease: systematic review and Bayesian network meta-analysis.2020Respiratory Research
Efficacy and cardiovascular safety profile of dual bronchodilation therapy in chronic obstructive pulmonary disease: a bidimensional comparative analysis across fixed-dose combinations.2019Pulmonary Pharmacology and Therapeutics
Once daily long-acting beta2-agonists and long-acting muscarinic antagonists in a combined inhaler versus placebo for chronic obstructive pulmonary disease.2019Cochrane Database of Systematic Reviews
Fixed-dose combination of umeclidinium and vilanterol for patients with chronic obstructive pulmonary disease: a systematic review.2019The Clinical Respiratory Journal
Impact of ICS/LABA and LABA/LAMA FDCs on functional and clinical outcomes in COPD: A network meta-analysis.2019Pulmonary Pharmacology & Therapeutics
Impact of prior and concurrent medication on exacerbation risk with long-acting bronchodilators in chronic obstructive pulmonary disease: a post hoc analysis.2019Respiratory research
Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.2019International Journal of Chronic Obstructive Pulmonary Disease

Clinical Practice Guidelines