Study: Semaglutide slowed progression of CKD, cut cardiovascular events, mortality risk
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Key takeaways:
- FLOW trial results showed a 24% lower risk of kidney disease events and an 18% lower risk of cardiovascular events.
- Findings also showed a 20% difference in all-cause mortality with semaglutide vs. placebo.
Use of the drug semaglutide in patients with type 2 diabetes significantly reduced the risk of major kidney disease events, cardiovascular outcomes and all-cause mortality vs. placebo, newly published data show.
“These benefits signify a profound clinical impact saving kidneys, hearts and lives for patients with type 2 diabetes and chronic kidney disease,” Vlado Perkovic, MB, PS, PhD, from the University of New South Wales in Sydney, said in a press release after findings from the Evaluate Renal Function with Semaglutide Once Weekly (FLOW) trial were presented at the annual European Renal Association Congress in Stockholm. “Additionally, the reassuring safety findings further support the strong potential value of semaglutide in this population,” he said.
The findings from the trial, funded by Novo Nordisk, were published simultaneously in the New England Journal of Medicine.
As Healio previously reported, Novo Nordisk ended the FLOW trial in October 2023 after results from an interim analysis met certain pre-specified criteria. The trial was initiated in 2019 in 28 countries at more than 400 investigator sites and compared the use of a weekly 1 mg injection of semaglutide vs. placebo in 3,533 patients.
The company reported initial results from the study in March.
Patients in the trial were randomly assigned in a 1:1 ratio to receive either semaglutide or placebo. Adults with type 2 diabetes were eligible for the trial if they had CKD and were receiving a stable dose of renin-angiotensin system inhibitors.
Researchers looked at the following five clinical indicators among patients in the trial when evaluating the impact of semaglutide on kidney function:
- onset of persistent 50% or greater reduction in eGFR compared with baseline;
- onset of persistent eGFR less than 15 mL/min/1.73 m2;
- initiation of chronic kidney replacement therapy (dialysis or kidney transplantation);
- death from kidney disease; and
- death from cardiovascular disease in patients with type 2 diabetes and CKD.
Secondary endpoints in the trial included adverse cardiovascular events, such as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death and all-cause death.
Results showed a 24% drop in progression of CKD among patients receiving semaglutide, based on the eGFR slope.
“The mean annual slope of the eGFR was significantly less steep (indicating a slower decrease) in the semaglutide group than in the placebo group,” the researchers wrote. “The risk of major cardiovascular events was 18% lower in the semaglutide group than in the placebo group (212 vs. 254 events) ... findings for myocardial infarction and death from cardiovascular causes were consistent with those in the primary analysis, but the findings for stroke showed a numerical imbalance in favor of placebo,” the researchers wrote.
“The risk of death from any cause was 20% lower in the semaglutide group than in the placebo group (227 vs. 279 events),” they wrote.
The trial had a median follow-up of 3.4 years.
Reference:
Semaglutide significantly reduces risk of major kidney disease events, cardiovascular outcomes and mortality in patients with type 2 diabetes and chronic kidney disease, groundbreaking study reveals.https://www.era-online.org/wp-content/uploads/2024/05/ERA_Congress_Press_Release_FLOW_Perkovic.pdf#:~:text=Participants%20who%20received%20semaglutide%20had,specific%20and%20cardiovascular%20death%20outcomes. Published May 24, 2024. Accessed May 27, 2024.
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