Drug updated on 11/1/2024
| Dosage Form | Powder (oral Inhalation; 62.5 mcg umeclidinium and 25 mcg vilanterol) |
| Drug Class | Anticholinergics 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
- 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 Title | Year | Source |
|---|---|---|
| Anoro Ellipta (umeclidinium and vilanterol) Prescribing Information. | 2023 | GlaxoSmithKline, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients with Stable COPD. | 2023 | Canadian Journal of Respiratory, Critical Care, and Sleep Medicine |
| 2022 GINA Report, global strategy for asthma management and prevention. | 2022 | Global Initiative for Asthma |
| LABA/LAMA as First-Line Therapy for COPD: A Summary of the Evidence and Guideline Recommendations. | 2022 | Journal of Clinical Medicine |
| Spanish COPD guidelines (GesEPOC) 2021: Updated pharmacological treatment of stable COPD. | 2021 | Archivos de Bronconeumologia |
| 2020 Gold pocket guide to COPD diagnosis, management, and prevention. | 2020 | Global Initiative for Chronic Obstructive Lung Disease |
| COPD-X Concise Guide. | 2020 | Lung Foundation Australia |
| Canadian Thoracic Society Clinical Practice Guideline on pharmacotherapy in patients with COPD – 2019 update of evidence. | 2019 | Canadian Journal of Respiratory, Critical Care, and Sleep Medicine |