Best Evidence Analyses and Commentary

A Novel COPD Medication
Keith Sawh, PharmD Candidate; Marcus Campbell, PharmD, BC-ADM
November 2013

Presently, no pharmacological treatment is shown to modify the rate of decline in lung function or disease progression.  Patients are commonly treated with bronchodilators to improve symptoms and reduce exacerbations: long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs). LAMAs and LABAs can be used as monotherapy or in combination depending on the severity of the disease. 

A growing body of evidence shows that LAMA and LABA co-administration is more effective than using either drug class alone. Co-administration has been shown to improve lung function (FEV1), symptoms, resting and dynamic hyperinflation, exercise capacity, and reduce exacerbations.3 

Other potential benefits of co-administration include reduced need for rescue medication compared with monotherapy, and decreased risk of adverse effects compared with increasing the dose of a single bronchodilator.

Recently, an FDA committee voted to recommend approval of a new combination product containing a LAMA (umeclidinium) and a LABA (vilanterol). The committee determined that the efficacy and safety data provided substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25 mcg dose) for the long-acting, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.4 Anoro Ellipta is the proprietary name for UMEC/VI, administered using the Ellipta inhaler. GlaxoSmithKline and Theravance, Inc. will be marketing this novel product.4 

Phase 3 studies of UMEC/VI in patients with chronic COPD included two 24-week efficacy studies that compared the combination, its components and placebo as well as two 24-week active comparator studies that compared the combination to tiotropium for the maintenance treatment of COPD.  For all 4 studies, the primary outcome was trough FEV1 at the end of 24 weeks, and inclusion criteria consisted of post bronchodilator  FEV1/FVC ration <0.70, post bronchodilator FEV1 70% predicted, and modified Medical Research Council (mMRC) dyspnea scores 2.  Two doses of UMEC/VI, 62.5/25 and 125/25 mcg were evaluated, and both doses were found to be similar with regard to efficacy and safety in the overall Phase 3 study population.

These UMEC/VI clinical trials involved over 4500 COPD patients. The most frequently reported adverse events across all treatment arms (including placebo) were headache, nasopharyngitis, cough, upper respiratory tract infection, and back pain. COPD exacerbation was the most common serious adverse event reported.

While Anoro Ellipta is not yet approved, it is the first product that delivers dual long-acting bronchodilators (LAMA AND LABA) via single inhaler device administered once daily.  If the FDA follows the recommendation of their advisory committee and the product gains approval, it may offer a simplified therapeutic option for patients that require dual long-acting bronchodilator therapy for control of their COPD.

 

References:

1. Gregory J. Feldman and Anton . “Current evidence and future prospects The combination of umeclidinium bromide and vilanterol in the management of chronic obstructive pulmonary disease.” Ther Adv Respir Dis published online 3 September 2013. DOI: 10.1177/1753465813499789.

2.  Gregory Feldman, Robert R. Walker, Jean Brooks, Rashmi Mehta and Glenn Crater. “28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: A randomized placebo-controlled trial.” Pulmonary Pharmacology & Therapeutics 25 (2012) 465-471. 

3.  Mario Cazzola, Clive P. Page, Luigino Calzetta, and M. Gabriella Matera.  Pharmacology and Therapeutics of Bronchodilators.” Pharmacol Rev 64 (2012):450–504.

4.   FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD.  Issued: 10th September 2013, London UK and South San Francisco, CA, USA.

 

 

 

 

 


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