ALBIGLUTIDE AND ATRIAL FIBRILLATION/ATRIAL FLUTTER IN PATIENTS WITH TYPE 2 DIABETES AND ESTABLISHED CARDIOVASCULAR DISEASE - A SECONDARY ANALYSIS OF THE HARMONY OUTCOMES TRIAL

AIMS:Atrial fibrillation and flutter (AF) are common in patients with Type 2 diabetes and are associated with worse outcomes. METHODS AND RESULTS:Harmony Outcomes was a multi-centre, event-driven, double-blind, placebo-controlled trial comparing the effects of albiglutide, a glucagon-like peptide-1 receptor agonist, with placebo on a composite of major adverse cardiac events (MACEs; non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in 9463 patients aged >40 years with Type 2 diabetes and established cardiovascular disease. Herein, the cardiovascular effects of albiglutide in patients with and without AF, as well as the effects on AF events during follow-up, were analysed. Patients with a history of AF (8.9%) exhibited a higher event rate for the primary composite MACE endpoint during 1.6 years of follow-up {12.7 vs. 6.3 events/100 person-years, adjusted hazard ratio [aHR] 1.41 [95% confidence interval (CI) 1.14-1.74], P = 0.001}. Treatment with albiglutide reduced the occurrence of the primary endpoint irrespective of history of AF at baseline (history of AF: aHR 0.83 [0.58-1.19], no history of AF: aHR 0.77 [0.66-0.90]; Pinteraction = 0.71). During follow-up, 239 patients (2.5%) experienced an AF event. Overall, albiglutide was associated with numerically fewer AF events [108 vs. 131; hazard ratio 0.82 (0.63-1.06), P = 0.12], irrespective of baseline history of AF (Pinteraction = 0.92). CONCLUSION:In patients with Type 2 diabetes, treatment with albiglutide, compared with placebo, reduced the risk of cardiovascular events irrespective of history of AF. Further, albiglutide treatment did not increase AF adverse events but was associated with a trend to a lower rate of AF events during follow-up without reaching statistical significance.