AT ACC 16
CHICAGO (FRONTLINE MEDICAL NEWS) – Using an inhaled long-acting beta agonist and corticosteroid to treat patients with moderate chronic obstructive pulmonary disease who have known cardiovascular disease had no impact on the cardiovascular event rate in the landmark SUMMIT trial, Dr. David E. Newby reported at the annual meeting of the American College of Cardiology.
SUMMIT (the Study to Understand Mortality and Morbidity) was a randomized, double-blind, placebo-controlled, 43-country, four-arm clinical trial in which 16,485 patients with moderate COPD were placed on once-daily inhaled fluticasone furoate/vilanterol 100/25 mcg by dry powder inhaler (Breo Ellipta), either drug alone, or placebo for an average of 2 years. Two-thirds of participants had overt cardiovascular disease; the rest were at high risk as defined by age greater than 60 years plus the presence of two or more cardiovascular risk factors.
This was the first large prospective clinical trial to investigate the impact of respiratory therapy on survival in patients with two commonly comorbid conditions. The incidence of major adverse cardiovascular events – a prespecified secondary endpoint – was of major interest because some other long-acting beta agonists have been linked to increased cardiovascular risk, explained Dr. Newby of the University of Edinburgh.
The primary endpoint in SUMMIT was all-cause mortality. The 12.2% relative risk reduction in the fluticasone furoate/vilanterol group, compared with placebo, didn’t achieve statistical significance. Neither did the 7.4% reduction in the secondary composite endpoint of cardiovascular death, MI, stroke, unstable angina, or TIA seen in the corticosteroid/LABA group, which is reassuring from a safety standpoint, he noted.
A positive result was seen for another secondary endpoint: the rate of lung function decline as measured by forced expiratory volume in 1 second. The rate of decline was 8 mL/year less with fluticasone furoate/vilanterol, compared with placebo.
The Breo Ellipta group also had significantly lower rates of moderate or severe COPD exacerbations, hospitalization for exacerbations, and improved quality of life as measured by the St. George’s Respiratory Questionnaire – COPD total score at 12 months.
The SUMMIT trial was sponsored by GlaxoSmithKline. The presenter is a consultant to GSK and eight other pharmaceutical companies.