medwireNews: The latest analyses from the LEADER trial show that liraglutide is effective against recurrent cardiovascular disease (CVD) and renal events in patients with type 2 diabetes.
Addressing attendees at the American Diabetes Association scientific sessions in San Diego, California, Richard Pratley (Florida Hospital Diabetes Institute, Orlando, USA) reported that the rate of recurrent CVD events was 13.0% in 4668 patients taking liraglutide (1.8 mg), compared with 14.9% among the 4672 patients in the placebo group, equating to a significant 14% risk reduction.
Returning to the primary outcome, reported a year ago, Pratley revealed that further analysis found the benefits with liraglutide persisted after accounting for use of CV drugs, such as beta blockers and statins, and for other diabetes medications.
“The main message is that liraglutide worked across a wide range of background medications,” said Pratley.
The researchers also attempted to ascertain what factors accounted for the CV benefits of liraglutide. However, they found no evidence of an association between CVD outcomes and liraglutide’s effect on glycated hemoglobin reduction, bodyweight, systolic blood pressure, or lipid levels.
Pratley listed other mechanisms by which a glucagon-like peptide-1 receptor agonist might be cardioprotective, such as through effects on beta or alpha cells, or on inflammation or coagulation, or even through direct effects on the heart.
“But the bottom line is that, in humans, we don’t actually know what the mechanism is for liraglutide’s benefit,” he concluded.
Stephen Bain (Swansea University, UK) then reported further details of microvascular and glycemic outcomes. Being a high-risk population, around 20% of patients had moderate renal impairment at baseline and 2% severe impairment; 26% had microalbuminuria and 10% macroalbuminuria.
Liraglutide significantly reduced the risk for renal events, with the hazard ratio for time to first event being a significant 0.78, driven mostly by reduced progression of proteinuria, and still significant after adjusting for use of renin angiotensin aldosterone system inhibitors. There was a moderate decline in estimated glomerular filtration rate in both groups, which was slightly but significantly – “by a whisker” – less in the liraglutide group than the placebo group.
“With all the caveats of multiple chopping of results and data, I think at least we can say that there doesn’t seem to be any renal harm in this group of patients,” said Bain.
Moving onto glycemic outcomes, he noted that more patients achieved glycated hemoglobin targets with liraglutide than placebo “despite attempts at glycemic equipoise,” with the researchers encouraged to add antidiabetic medications as needed. Patients taking liraglutide were 48% less likely than placebo-treated patients to receive insulin, and 37% less likely to initiate any new antidiabetic medication.
Finally, Bain reported that quality of life scores in a subset of patients who completed the EQ-5D questionnaire fell over time, as expected for a chronic disease, but the decline was smaller in the liraglutide group, “which I think is another positive benefit of the study.”
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