Albiglutide Beats Placebo for Cardiovascular Events in T2DM
Despite having been withdrawn, albiglutide is superior to placebo for reducing cardiovascular events
(HealthDay News) -- For patients with type 2 diabetes and existing cardiovascular disease, albiglutide results in fewer cardiovascular events, according to a study published online Oct 2 in The Lancet to coincide with the annual meeting of the European Association for the Study of Diabetes, held from Oct. 1 to 5 in Berlin.
Noting that in 2017, GlaxoSmithKline withdrew the glucagon-like peptide 1 (GLP-1) receptor agonist albiglutide for commercial reasons, Adrian F. Hernandez, MD, from the Duke University School of Medicine in Durham, NC, and colleagues presented the results from a randomized multicenter international trial involving albiglutide. Patients aged 40 years and older with type 2 diabetes and cardiovascular disease were randomly assigned to receive a subcutaneous injection of albiglutide or a matched volume of placebo (4731 and 4732 patients, respectively).
The intention-to-treat population was followed for a median of 1.6 years for the primary outcome. The researchers found that the primary composite outcome (first occurrence of cardiovascular death, myocardial infarction, or stroke) occurred in 7 and 9% of patients in the albiglutide and placebo groups, respectively (hazard ratio, 0.78), indicating that albiglutide was superior to placebo (P<0.0001 for noninferiority; P=0.0006 for superiority).
"Harmony-Outcomes was an important study for us to complete to generate new data and insights about the role of the GLP-1 receptor agonist class in the management of patients with diabetes and cardiovascular disease," John Lepore, MD, from GlaxoSmithKline, said in a statement. "We continue to explore opportunities to divest this medicine to a company with the right expertise and resources to realize its full potential for patients."
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which funded the study.
Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. (published online Oct 2, 2018.)
Mafham M and Preiss D. HARMONY or discord in cardiovascular outcome trials of GLP-1 receptor agonists? Lancet.