Umeclidinium and vilanterol

(Anoro Ellipta®)

Umeclidinium and vilanterol

Drug updated on 11/1/2024

Dosage FormPowder (oral Inhalation; 62.5 mcg umeclidinium and 25 mcg vilanterol)
Drug ClassAnticholinergics and beta-2 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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  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Umeclidinium/vilanterol (UMEC/VI) demonstrated strong effectiveness in improving FEV1, ranking second with a SUCRA (surface under cumulative rankings) score of 93.5%, and showed statistically significant greater improvements in FEV1 at 24 weeks compared to all dual and mono-bronchodilator comparators, with an E(max) of 0.185 L.
  • In patients with stable COPD (chronic obstructive pulmonary disease), UMEC/VI provided similar improvements in the St. George's Respiratory Questionnaire (SGRQ) total score compared to other long-acting muscarinic antagonists (LAMAs) / long-acting beta2-agonists (LABAs) combinations and significantly greater improvements compared to several monotherapies, while also reducing rescue medication use and improving outcomes in annualized moderate/severe exacerbation rates.
  • For patients with moderate-to-severe COPD, LABA/LAMA combinations, including UMEC/VI, were found to be more effective than ICS/LABA fixed-dose combinations in improving FEV1.
  • The rate of adverse events (AEs) between umeclidinium/vilanterol (UMEC/VI) and tiotropium (TIO) was not significant, indicating comparable safety profiles, while different LABA/LAMA fixed-dose combinations (FDCs) and placebo showed similar outcomes regarding mortality, serious adverse events (SAEs), and withdrawals due to AEs.
  • There were no significant differences among LAMA/LABA combinations, including UMEC/VI, in terms of moderate to severe exacerbations, all-cause mortality, major adverse cardiovascular events, or pneumonia.
  • The population types studied included symptomatic patients with COPD from the Chinese National Healthcare System, stable COPD patients followed for 48 weeks, and moderate-to-severe COPD patients, with findings indicating that UMEC/VI was cost-effective and clinically efficacious in symptomatic COPD patients, while LABA/LAMA combinations, including UMEC/VI, were more effective than ICS/LABA fixed-dose combinations in improving FEV1 for moderate-to-severe COPD patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Anoro Ellipta (umeclidinium and vilanterol) Prescribing Information.2023GlaxoSmithKline, Philadelphia, PA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines