- A large scale clinical trial, called SUMMIT, involving 16,485 subjects across 43 countries assessing the impact of GlaxoSmithKline (GSK +2%) and Theravance's (THRX) Relvar/Breo Ellipta (fluticasone/vilanterol dry powder for inhalation) on cardiovascular disease (CVD) in patients with COPD (chronic obstructive pulmonary disease) with either a history or increased risk of CVD failed to achieve its primary endpoint of a statistically significant reduction in the risk of dying compared to placebo (p=0.137) despite an observed reduction of 12.2%.
- A secondary endpoint of reducing the risk of experiencing a CV event while on treatment also failed to achieve statistical significance (p=0.475) despite an observed reduction of 7.4% versus placebo.
- Treatment with Relvar did show a statistically significant reduction in reducing the rate of lung function decline compared to placebo (p=0.019), but statistical significant cannot be inferred because the study failed to achieve its primary endpoint.
- SUMMIT was the first study of its kind with the aim of better understanding the effect of respiratory treatments on COPD patients with a risk of CVD. The company intends to present the data at future medical conferences and for publication.
- The FDA approved the product for COPD in May 2013.