Respiratory Medicine has published positive results from a third lung function study comparing the efficacy and safety of Anoro Ellipta (umeclidinium /vilanterol, ‘UMEC/VI’), the combination long-acting muscarinic antagonist (LAMA) / long-acting beta2-adrenergic agonist (LABA), with the LAMA tiotropium, administered in the HandiHaler® inhaler, in patients with chronic obstructive pulmonary disease (COPD).
In this study UMEC/VI 62.5/25 mcg showed a statistically significant improvement of 112mL compared with tiotropium 18mcg (95% confidence interval (CI) 81, 144, p<0.001) for the primary endpoint measurement of lung function using trough forced expiratory volume in one second (FEV1) at the end of the treatment period (day 169).
For the secondary endpoint measurement of lung function using weighted mean FEV1 0 C 6 hour, at the end of the treatment period (day 168) UMEC/VI 62.5/25mcg showed a statistically significant improvement of 105mL, (95% confidence interval (CI) 71, 140, p<0.001) compared to tiotropium 18 mcg.
The most commonly reported side effects for both UMEC/VI and tiotropium included headache (9% UMEC/VI; 7% tiotropium), nasopharyngitis (6% UMEC/VI; 7% tiotropium), cough (3% UMEC/VI; 3% tiotropium) and back pain (2% UMEC/VI; 3% tiotropium). The overall incidence of on-treatment adverse events was 44% in the UMEC/VI group and 42% in the tiotropium group. The incidence of any on-treatment serious adverse event in both treatment arms was 4%.
Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said: “We are pleased to announce the publication of these important data comparing Anoro Ellipta with tiotropium. These results support the lung function benefit of Anoro Ellipta in the treatment of appropriate patients with COPD. We hope the publication will inform physicians as they consider which treatment option is best to meet their individual patient’s needs.”
Michael W. Aguiar, President and Chief Executive Officer of Theravance, said: “We believe the results from this positive study will provide physicians with additional useful data regarding the potential benefits of Anoro Ellipta as a treatment option for appropriate patients with COPD.”
UMEC/VI previously demonstrated statistically significant improvements in trough FEV1 compared with tiotropium in an earlier six-month active-comparator study (DB2113360), and numerically greater (although not statistically significant) improvements from tiotropium in another. These data were previously announced in July 2012.
Date: October 17, 2014
Source: GSK
Filed Under: Drug Discovery
