Heart. 2017 Apr 17. pii: heartjnl-2016-310897. doi: 10.1136/heartjnl-2016-310897. [Epub ahead of print]
Brook RD1, Anderson JA2, Calverley PM3,4, Celli BR5, Crim C6, Denvir MA7, Magder S8, Martinez FJ9, Rajagopalan S10, Vestbo J11, Yates J6, Newby DE12; SUMMIT Investigators.
1 Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA [email protected].
2 Research & Development, GlaxoSmithKline, Uxbridge, UK.
3 Department of Medicine, University of Liverpool, Liverpool, UK.
4 Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK.
5 Pulmonary and Critical Care Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA.
6 Research & Development, GSK, Research Triangle Park, North Carolina, USA.
7 Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
8 Research Institute of the McGill University Health Centre, McGill University, Montreal, Canada.
9 Joan and Sandy Weill Department of Medicine, Weill Cornell Medicine, New York, New York, USA.
10 Cardiovascular Medicine, University of Maryland, College Park, Maryland, USA.
11 Centre for Respiratory Medicine and Allergy, Manchester Academic Health Science Centre, The University of Manchester and South Manchester University Hospital NHS Foundation Trust, Manchester, UK.
12 British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
Cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) often coexist. We assessed the effect of inhaled COPD treatments on CVD outcomes and safety in patients with COPD and at heightened CVD risk.
The SUMMIT (Study to Understand Mortality and MorbidITy) was a multicentre, randomised, double-blind, placebo-controlled, event-driven trial in 16 485 patients with moderate COPD who had or were at high risk of CVD. Here, we assessed the prespecified secondary endpoint of time to first on-treatment composite CVD event (CVD death, myocardial infarction, stroke, unstable angina or transient ischaemic attack (TIA)) by Cox regression and by clinician-reported CVD adverse events across the four groups: once-daily inhaled placebo (n=4111), long-acting beta2-agonist (vilanterol (VI) 25 µg; n=4118), corticosteroid (fluticasone furoate (FF) 100 µg; n=4135) and combination therapy (FF/VI; n=4121).
Participants were predominantly middle-aged (mean 65 (SD 8) years) men (75%) with overt CVD (66%). The composite CVD endpoint occurred in 688 patients (first event: sudden death (35%), acute coronary syndrome (37%) and stroke or TIA (23%)), and was not reduced in any treatment group versus placebo: VI (HR 0.99, 95% CI 0.80 to 1.22), FF (HR 0.90, 95% CI 0.72 to 1.11) and their combination (HR 0.93, 95% CI 0.75 to 1.14). Outcomes were similar among all subgroups. Adverse events, including palpitations and arrhythmias, did not differ by treatment.
In patients with COPD with moderate airflow limitation and heightened CVD risk, treatment with inhaled VI, FF or their combination has an excellent safety profile and does not impact CVD outcomes.
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