New findings from a large-scale, international clinical trial have found a significant reduction in the first occurrence of a heart attack, stroke, or death, and a reduction in the progression of kidney disease in patients with type 2 diabetes who received a weekly injection of efpeglenatide.
“The AMPLITUDE O trial established efpeglenatide, an exendin-4 based GLP-1 RA, as an effective cardioprotective drug for [patients with] type 2 diabetes with cardiovascular and/or kidney disease,” said Hertzel C. Gerstein, MD, MSc, deputy director of the Population Health Research Institute in Ontario, Canada, in a press release.
The new data were presented at the 81st Scientific Sessions of the American Diabetes Association (ADA) and were simultaneously published in The New England Journal of Medicine. Efpeglenatide is an injectable drug with glucose- and weight-lowering effects, according to the ADA.
The vast majority of adults (98%) with type 2 diabetes have at least one comorbid chronic condition, such as cardiorenal conditions that impact the heart and kidneys. Specifically, 24% of people living with diabetes have kidney disease, 22% have cardiovascular disease, and 82% have hypertension, according to the ADA.
As a glucagon-like peptide-1 receptor agonist drug (GLP-1 RA), efpeglenatide is used to treat diabetes by reducing glucose levels, weight, and blood pressure. Earlier research has shown that GLP-1 RA drugs based on human GLP-1 reduce cardiovascular and kidney outcomes, and the AMPLITUDE O trial assessed the impacts of a GLP-1 RA based on exendin-4 either with or without a sodium-glucose co-transporter 2 (SGLT2) inhibitor drug in patients with cardiovascular or kidney disease.
The clinical trial was conducted in 28 countries and included more than 4000 patients with type 2 diabetes. Over 2 years, patients who received weekly injections of efpeglenatide versus placebo had a 27% lower risk of a heart attack, stroke, or cardiovascular death, according to the ADA. Furthermore, researchers found a 32% lower risk of kidney disease progression and a 27% lower risk of heart attack, stroke, or death from any cause in the efpeglenatide arm.
Similar effects were seen both with and without an SGLT2 inhibitor, according to the ADA.
“We are encouraged that this once-a-week injection safely and effectively reduced cardiovascular and progression of kidney disease in patients with long-standing diabetes who had a high prevalence of cardiovascular and kidney disease,” Gerstein concluded in the press release.