Albiglutide and atrial fibrillation in patients with type 2 diabetes and established cardiovascular disease - insights from the Harmony Outcomes trial.

Abstract

Introduction: Atrial fibrillation and flutter (AF) are common in patients with type 2 diabetes and are associated with worse outcomes.

Methods: Harmony Outcomes was a multicenter, event-driven, double-blind, placebo-controlled trial comparing the effects of albiglutide, a glucagon-like peptide-1 (GLP1) receptor agonist, with placebo on a composite of major adverse cardiac events (MACE; non-fatal myocardial infarction; non-fatal stroke and cardiovascular death) in 9,463 patients aged >40years 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 analyzed.

Results: 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: aHR0.83 (0.58-1.19), no history of AF: aHR0.77 (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; HR 0.82 (0.63-1.06, p=0.12), irrespective of baseline history of AF (pinteraction=0.92).

Conclusions: In patients with type 2 diabetes, treatment with albiglutide, compared to 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.