The primary outcome was the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1.30, closed testing for superiority was prespecified. The researchers suggest from their findings that evidence-based glucagon-like peptide 1 receptor agonists should be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes.
A commentary notes that in 2017, GlaxoSmithKline announced its intention to withdraw albiglutide for commercial reasons. This announcement came before the emergence of definitive evidence regarding the cardiovascular safety and efficacy of albiglutide. It suggests that international guidelines should reflect the increasing weight of evidence that supports the use of GLP-1 receptor agonists in patients with diabetes and cardiovascular disease. It calls for further studies investigating their effects in people with diabetes but without known vascular disease are now a priority to better inform the clinical community in the selection of glucose-lowering drugs in such patients. It adds that since the beneficial cardiovascular effects of these drugs might not be mediated through control of glycaemia, clinical trials of GLP-1 receptor agonists in people with cardiovascular disease but without diabetes are warranted and such trials are underway. It concludes that given the clear cardiovascular benefit observed with albiglutide in the Harmony Outcomes trial, GlaxoSmithKline should reconsider making it available to patients.