Semaglutide Produces Positive Kidney and CV Outcomes in the Flow Trial
SOURCE: Radcliffe Cardiology, Carrie Barclay; Special Editor: Greg Guillory
PUBLISHED:

Outcomes from the FLOW trial (NCT03819153) demonstrated reduced kidney disease progression and CV events including mortality outcomes with semaglutide as compared to placebo in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). Due to the efficacy of this study, it was recommended by the independent data monitoring committee to stop the trial early.  

Methodology: 

  • FLOW was a randomised, double-blind parallel-group, placebo-controlled superiority trial.  
  • 3,533 people with type 2 diabetes and chronic kidney disease were randomly assigned to receive either once-weekly semaglutide 1mg or placebo and standard of care. The trial was conducted in 28 countries.  
  • The composite primary endpoint included an onset of 50% or greater reduction in estimated glomerular filtration rate (eGFR) compared to baseline, an onset of persistent eGFR less than 15ml/min/1.73m2 , an initiation of chronic kidney replacement therapy, death from kidney disease and death from cardiovascular disease.   
  • Secondary endpoints of the trial included annual rate of change in eGFR and major adverse cardiac events (MACE). 

Results: 

  • The trial met its primary endpoint, demonstrating a statistically significant reduction in kidney disease progression, and cardiovascular and kidney death at 24% in the group treated with semaglutide as compared to placebo.  
  • Semaglutide 1.0mg appeared safe and well-tolerated, in line with previous trials.  
  • Novo Nordisk reported that semaglutide was also found to be superior to placebo in accordance to secondary endpoints.  

Novo Nordisk are set to file for regulatory approvals of label expansion for semaglutide (Ozempic) in both the United States and the European Union in 2024, with the full results of the FLOW trial to be presented at an upcoming scientific conference.  

 

References: 

Novo Nordisk A/S: Semaglutide 1.0 mg demonstrates 24% reduction in the risk of kidney disease-related events in people with type 2 diabetes and chronic kidney disease in the FLOW trial, Novo Nordisk, 5th March, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=167028 [accessed 6th March 2024] 

 

A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW), Clinical Trials, 2024. https://clinicaltrials.gov/study/NCT03819153 [Accessed 6th March 2024] 

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