A groundbreaking study presented at the 61st ERA Congress in Stockholm has revealed that
semaglutide significantly lowers the risk of severe
kidney events, cardiovascular outcomes, and overall mortality in patients with
type 2 diabetes and
chronic kidney disease. This pivotal research, known as the FLOW (Evaluate Renal Function with
Semaglutide Once Weekly) study, has provided compelling evidence supporting the efficacy and safety of semaglutide, a weekly administered
GLP-1 (glucagon-like peptide 1) receptor agonist.
The FLOW study was a robust, double-blind, randomized, placebo-controlled international trial, which included 3,533 participants and had a median follow-up period of 3.4 years. The primary objective of the trial was to evaluate semaglutide's ability to prevent major kidney-related outcomes such as
kidney failure, significant loss of kidney function, and death from kidney or cardiovascular causes in patients suffering from both type 2 diabetes and chronic kidney disease. Participants were assigned to receive either a 1.0 mg dose of semaglutide once weekly or a placebo.
The findings from the study were remarkable. Participants who were administered semaglutide experienced a 24% reduction in the risk of the composite primary endpoint, which included kidney outcomes and death due to cardiovascular and kidney causes, compared to the placebo group. This risk reduction was consistent across both kidney-specific and cardiovascular death outcomes, underscoring the broad benefits of semaglutide.
Secondary outcomes of the study also highlighted the efficacy of semaglutide. The annual decline in eGFR (estimated glomerular filtration rate), a critical measure of kidney function, was slower by 1.16 ml/min/1.73m2/year in the semaglutide group compared to the placebo group. Additionally, the risk of major cardiovascular events was reduced by 18%, and all-cause mortality was lowered by 20% in those receiving semaglutide.
Professor Vlado Perkovic, a key figure in the study, remarked on the profound clinical impact of these findings. He stated, "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. Additionally, the reassuring safety findings further support the strong potential value of semaglutide in this population."
Chronic kidney disease, which affects over 800 million people globally, is particularly common among individuals with type 2 diabetes. The condition significantly increases the risk of kidney failure, cardiovascular events, and death, making research into its prevention and treatment crucial.
The FLOW trial was overseen by an academic-led Steering Committee in collaboration with
Novo Nordisk, the study sponsor who also managed the trial operations. The study's results are being published today in the New England Journal of Medicine and were presented at the 61st ERA Congress in Stockholm, Sweden. With the compelling evidence from this study, semaglutide stands out as a promising treatment option for patients grappling with the dual burdens of type 2 diabetes and chronic kidney disease.
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