The molecule reduces the risk of kidney disease by 24% in people with type 2 diabetes and chronic kidney disease
Compilation
Semaglutide 1 mg reduces the risk of kidney disease by 24% in people with type 2 diabetes and chronic kidney disease (CKD). This is confirmed by the main results of the FLOW study published in the journal. New England Journal of Medicine (NEJM) and recently presented in 61st Congress European Kidney Association (WAS).
Publication of the data follows the decision to stop the study early due to efficacy results, announced on October 10, 2023, based on the recommendation Independent data monitoring committee.
““We are very pleased with the results of the FLOW study, which show that this molecule reduces the risk of kidney disease progression.”
This is a randomized, double-blind clinical trial comparing this molecule with a placebo added to conventional treatment in preventing the progression of kidney failure and the risk of renal and cardiovascular mortality in people with type 2 diabetes. and CKD.
The study included 3533 subjects who were followed for an average of 3.4 years, of whom 93% were at high or very high risk of progression to CKD. As inclusion criteria, patients had to indicate: glomerular filtration rate and urine albumin-creatinine ratio.
The study achieved its primary goal, demonstrating that the aforementioned molecule reduced the overall renal target by 24% compared to placebo. The primary endpoint included five components measuring both CKD progression and mortality from renal and cardiovascular causes: time to sustained decline in the CKD-EPI equation from baseline; onset of persistent eGFR; initiation of chronic renal replacement therapy (dialysis or kidney transplantation); death from kidney disease or death from cardiovascular disease.
“Approximately 40% of people with type 2 diabetes have chronic kidney disease, so FLOW’s positive results demonstrate the drug’s potential to become the first GLP-1 treatment option.”
Both the renal and cardiovascular components contributed to the primary goal. Kidney benefits are also evident when analyzing data on albuminuria and annual eGFR. In this sense, the molecule, compared to placebo, is observed to provide a 32% reduction in albuminuria and minimize the annual decline in eGFR.
In addition, semaglutide 1 mg was confirmed to be superior to placebo in confirmatory secondary endpoints, reflected by an 18% reduction in major cardiovascular events (MACE) and a 20% reduction in all-cause mortality compared with placebo.
Finally, the molecule demonstrated significant reductions in glycated hemoglobin and weight, and the safety profile and tolerability were consistent with previous studies conducted.
“We are very pleased with the results of the FLOW study, which show that this molecule reduces the risk of progression of kidney disease. Approximately 40% of people with type 2 diabetes have chronic kidney disease, so FLOW’s positive results demonstrate the drug’s potential to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.“he declared Martin Holst LangeExecutive Vice President of Development at Novo Nordisk.
The company hopes to present the study results to health authorities this year.