GSK reports positive results from Harmony Outcomes albiglutide trial

4th October 2018 (Last Updated October 4th, 2018 00:00)

GlaxoSmithKline (GSK) has reported positive results from the Phase lV Harmony Outcomes trial evaluating the effect of albiglutide on major adverse cardiovascular (CV) events of patients with type 2 diabetes and cardiovascular disease.

GlaxoSmithKline (GSK) has reported positive results from the Phase lV Harmony Outcomes trial evaluating the effect of albiglutide on major adverse cardiovascular (CV) events of patients with type 2 diabetes and cardiovascular disease.

The randomised, double-blind, placebo-controlled trial enrolled 9,463 patients with type 2 diabetes and cardiovascular disease at 610 sites in 28 countries worldwide.

As part of the trial, patients were randomised to receive a once-weekly subcutaneous injection of albiglutide at 30mg (potentially increasing to 50mg) or placebo along with standard care.

The results demonstrated that albiglutide was better than placebo in lowering the risk of major adverse cardiovascular events (MACE) by 22% when used together with standard of care in the enrolled patients.

During the trial, albiglutide was administered subcutaneously once in a week over a median period of 1.6 years.

"This large cardiovascular outcome trial has shown impressive results for albiglutide in lowering the risk of major adverse cardiovascular events and adds important evidence that certain GLP-1 receptor agonists can improve cardiovascular outcomes."

It was also found that MACE occurred in 7.1% and 9.0% (N=428) of patients respectively treated with albiglutide and placebo in addition to standard of care.

The number of patients requiring the treatment of albiglutide to prevent one event over 1.6 years was 50.

The trial’s primary goal was the first occurrence of cardiovascular death, myocardial infarction, or stroke.

GSK conducted the trial in partnership with US-based Duke University School of Medicine unit Duke Clinical Research Institute (DCRI).

Duke University School of Medicine Clinical Research vice dean Adrian Hernandez said: “This large cardiovascular outcome trial has shown impressive results for albiglutide in lowering the risk of major adverse cardiovascular events and adds important evidence that certain GLP-1 receptor agonists can improve cardiovascular outcomes.

“Despite the need for treatments to manage these events, there was uncertainty about the cardiovascular effects of GLP-1 receptor agonists as a class due to mixed results from previous studies.”