Albiglutide reduces cardiovascular risk in patients with type 2 diabetes
medwireNews: Results of the Harmony Outcomes trial indicate that adding the glucagon-like peptide (GLP)-1 receptor agonist albiglutide to standard care may reduce cardiovascular risk among patients with type 2 diabetes and existing cardiovascular disease (CVD).
As reported at the 54th EASD Annual Meeting in Berlin, Germany, and published simultaneously in The Lancet, the composite cardiovascular outcome of myocardial infarction, stroke, or death from cardiovascular causes occurred over a median follow-up of 1.6 years in 7% of the 4731 participants who were randomly assigned to receive subcutaneous albiglutide 30 mg once weekly (with intensification to 50 mg once weekly if additional glucose lowering was needed) in addition to standard diabetes and CVD treatment.
By comparison, 9% of 4732 patients given add-on placebo experienced the composite outcome, translating into corresponding event rates of 4.57 versus 5.87 per 100 person–years and a significant 22% risk reduction for those in the albiglutide group.
“The number of patients needed to treat with albiglutide […] to prevent one major adverse cardiovascular event was 50,” John McMurray (University of Glasgow, UK) explained in his presentation at the EASD conference.
When the components of the composite outcome were analyzed separately, albiglutide reduced the risk for myocardial infarction by a nominally significant 25% relative to placebo, but the hazard ratios for death from cardiovascular causes and stroke were not statistically significant between the two groups.
Compared with previously published trials testing other GLP-1 receptor agonists, “the effects that we observed [with albiglutide] were consistent with the benefits of liraglutide and semaglutide, but they appear greater than those of lixisenatide and exenatide,” write the study authors. They note, however, that “[w]hether there are real differences among the findings of these trials is uncertain” because a number of factors – including the specific drug and dose, different study participants, and treatment adherence – could explain the variation in results.
Patients in the albiglutide group were significantly more likely to experience injection site reactions than those given placebo (1.8 vs 0.6%), but had lower rates of severe hypoglycemia (0.7 vs 1.2%). The incidence of serious adverse events, including acute pancreatic cancer, and medullary thyroid carcinoma, was comparable between the two study arms.
“These findings provide more evidence that certain GLP-1-receptor agonists can improve cardiovascular outcomes in patients with type 2 diabetes,” write the researchers.
The authors of an accompanying commentary, Marion Mafham and David Preiss, both from the University of Oxford in the UK, agree, emphasizing that the “clear” results are “an important step in the emerging story of GLP-1 receptor agonists.”
They note that clinical development of albiglutide was stopped for commercial reasons in 2017, but believe that “given the clear cardiovascular benefit” shown in the Harmony Outcomes trial, the sponsor “should reconsider making it available to patients.”
Indeed, Lawrence Leiter (University of Toronto, Ontario, Canada) told EASD delegates that GlaxoSmithKline (Brentford, UK) has announced its intention to make albiglutide available to patients through another company.
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