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Semaglutide 1.0 mg (Ozempic) Reduced Kidney Events 24% in FLOW Trial

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Novo Nordisk announced topline data from the FLOW trial indicate semaglutide 1.0 mg (Ozempic) was associated with a 24% reduction in risk of kidney disease-related events among individuals with type 2 diabetes and CKD compared to placebo therapy.

Use of semaglutide 1.0 mg (Ozempic) was associated with a 24% reduction in risk of kidney disease-related events among people with type 2 diabetes and chronic kidney disease (CKD), according to topline results of the FLOW trial.

A placebo-controlled trial with more than 3500 patients with type 2 diabetes and CKD, Novo Nordisk announced FLOW had met its primary endpoint for reducing risk of a composite endpoint comprised of 5 components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. This announcement comes less than 5 months after Novo Nordisk announced they were stopping the trial early due to efficacy based on a recommendation from an Independent Data Monitoring Committee.1,2

"Ozempic has demonstrated A1c reduction, cardiovascular risk reduction and now top line FLOW results of 24% reduction in the risk of kidney disease-related events in people with type 2 diabetes and chronic kidney disease compared to placebo. This adds significantly to the options for treatments for the 40% of patients that develop diabetes-related CKD," said HCPLive advisory board member Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center. "Clinically I cannot wait to see what combination therapy with SGLT2 inhibitors and/or Kerendia will demonstrate."

A randomized, double-blind, parallel-group, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for people with type 2 diabetes and CKD, FLOW enrolled 3533 people from more than 2 dozen countries. Launched in 2019, the trial included patients with eGFR of ≥50 and ≤75mL/min/1.73 m2 and UACR >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100 and <5000 mg/g.1

The primary outcome of interest was a composite of the 5 following endpoints:1

  • Onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared with baseline,
  • Onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2
  • Initiation of chronic kidney replacement therapy (dialysis or kidney transplantation)
  • Death from kidney disease
  • Death from cardiovascular disease

In addition to the topline result demonstrating a 24% relative reduction in risk of the primary endpoint, the release from Novo Nordisk also pointed out this effect appeared to be driven by benefits on both the kidney and cardiovascular components of the composite outcome. According to their announcement, Novo Nordisk intends to file for regulatory approvals of a label expansion for Ozempic in the US and the European Union in 2024. The company also noted plans to present full results of the FLOW trial at a scientific congress in 2024.1

"We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk1. “Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.”

References:

  1. Novo Nordisk. 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 Press Releases. March 5, 2024. Accessed March 5, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=167028#.
  2. Novo Nordisk. Novo Nordisk will stop the once-weekly injectable semaglutide kidney outcomes trial, FLOW, based on interim analysis. Novo Nordisk Press Releases. March 5, 2024. Accessed March 5, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=166327.

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