Efpeglenatide lowers CV and kidney disease risk in high-risk diabetes patients: Study
The cardiovascular and renal benefits occurred independently of the baseline use of SGLT2 inhibitors, the baseline use of metformin, and the baseline estimated glomerular filtration rate.
Canada: Weekly injections of efpeglenatide lowered the risk of cardiovascular (CV) and renal events in type 2 diabetes (T2D) patients having either a history of CVD or current kidney disease with at least one CV factor, show findings from the AMPLITUDE-O trial. AMPLITUDE-O is a randomized, placebo-controlled trial conducted at 344 sites across 28 countries.
The findings of the study were presented at the 81st Scientific Sessions of the American Diabetes Association (ADA) and subsequently published in the New England Journal of Medicine.
Efpeglenatide is a long-acting exendin-4–based glucagon-like peptide-1 receptor agonist (GLP-1 RA). Hertzel C. Gerstein, professor at McMaster University and Hamilton Health Sciences, Ontario, Canada, and colleagues aimed to determine the effect of efpeglenatide on cardiovascular and renal outcomes in patients with type 2 diabetes and either a history of cardiovascular disease or current kidney disease (defined as an estimated glomerular filtration rate of 25.0 to 59.9 ml per minute per 1.73 m2 of body-surface area) plus at least one other cardiovascular risk factor.
People (n=4076) were randomly assigned in a ratio of 1:1:1 to receive weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg (n=2717) or placebo (n=1359). Randomization was stratified according to the use of sodium-glucose cotransporter 2 inhibitors.
The primary outcome was the first major adverse cardiovascular event (MACE; a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or undetermined causes).
During a median follow-up of 1.81 years, the researchers found that:
- Incident MACE occurred in 7.0% participants assigned to receive efpeglenatide (3.9 events per 100 person-years) and 125 participants (9.2%) assigned to receive placebo (5.3 events per 100 person-years) (hazard ratio, 0.73).
- A composite renal outcome event (a decrease in kidney function or macroalbuminuria) occurred in 13.0% participants assigned to receive efpeglenatide and in 18.4% assigned to receive placebo (hazard ratio, 0.68).
- Diarrhea, constipation, nausea, vomiting, or bloating occurred more frequently with efpeglenatide than with placebo.
"In this trial involving people with type 2 diabetes who had either a history of cardiovascular disease or current kidney disease plus at least one other cardiovascular risk factor, the risk of cardiovascular events was lower among those who received weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg than among those who received placebo," wrote the authors.
The study titled, "Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes," is published in the New England Journal of Medicine.