The trial was presented recently at the 61st European Renal Association Congress. The FLOW (Evaluate Renal Function with Semaglutide Once Weekly) study is a double-blind, randomized, placebo-controlled, international trial involving 3,533 participants, with a median follow-up period of 3.4 years.
The industry-sponsored study was published simultaneously in the New England Journal of Medicine.
FLOW was designed to assess the efficacy and safety of semaglutide, a once-weekly SC GLP-1 receptor agonist, in preventing major kidney outcomes, such as kidney failure, substantial loss of kidney function, and death from kidney or cardiovascular causes, in patients with T2D and CKD. The participants received either semaglutide 1.0 mg once weekly or placebo.
The researchers reported that those who received semaglutide had a 24% risk reduction for the composite primary endpoint, including kidney outcomes and death due to cardiovascular and kidney causes, compared with those who received placebo.
Significant improvements with semaglutide were also shown with secondary endpoints: The total estimated glomerular filtration rate (eGFR) slope was 1.16 mL/min/1.73 m2/year slower, the risk of major cardiovascular events was decreased by 18%, and the risk of all-cause mortality was reduced by 20%.
“The use of semaglutide in people with type 2 diabetes and chronic kidney disease can lower the risk of major kidney outcomes and reduce the risk of cardiovascular events, cardiovascular death and all-cause death. These benefits signify a profound clinical impact saving kidneys, hearts and lives, for patients with type 2 diabetes and chronic kidney disease,” noted presenter Vlado Perkovic, MBBS, PhD, of the University of New South Wales. “Additionally, the reassuring safety findings further support the strong potential value of semaglutide in this population.”
For the study, patients with T2D and CKD (defined by an eGFR rate of 50 to 75 mL/min/1.73 m2 and a urinary albumin-to-creatinine ratio [with albumin measured in mg and creatinine measured in g] of >300 and <5,000 or an eGFR of 25 to <50 mL/min/1.73 m2 and a urinary albumin-to-creatinine ratio of >100 and <5,000) to receive SC semaglutide at a dose of 1.0 mg weekly or placebo.
Among the participants who underwent randomization—1,767 in the semaglutide group and 1,766 in the placebo group—median follow-up was 3.4 years, after early trial cessation was recommended at a prespecified interim analysis. The risk of a primary-outcome event was found to be 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, 0.76; 95% CI, 0.66-0.88; P = .0003).
“Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney disease,” the researchers concluded.
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