In patients with type 2 diabetes and kidney disease, Ozempic (semaglutide) reduced kidney disease progression, major adverse cardiovascular events (MACE) and death by 24%, according to topline results from the FLOW trial.1 The trial was stopped early on the recommendation from an independent data monitoring committee because an interim analysis found the study met the criteria for efficacy.
In the trial, which enrolled 3533 people with type 2 diabetes and chronic kidney disease, patients were randomized to receive Ozempic 1.0 mg with placebo or placebo, along with standard of care for kidney disease.
Key Takeaways
- The FLOW trial, which was stopped early based on an interim analysis that found that it had met the criteria for efficacy, demonstrated that Ozempic reduced kidney disease progression and MACE by 24%.
- Ozempic is a (GLP-1 receptor agonist, which belongs to a class of drugs that work in the pancreas to enhance insulin release.
- Positive results from the FLOW trial demonstrate the potential for Ozempic to become the first GLP-1 treatment option for people living with T2D and chronic kidney disease.
Secondary endpoints—including annual rate of change in eGFR1 and non-fatal myocardial infarction, non-fatal stroke, cardiovascular death—also confirmed the positive impact on slowing kidney disease and cardiovascular events.
Ozempic, which was developed by Novo Nordisk, is available in 0.5 mg, 1.0 mg and 2.0 mg doses. It is a glucagon-like peptide-1 (GLP-1) inhibitor, a class of drugs that work in pancreas to enhance insulin release. The list price for Ozempic 1.0 mg is $935.77 for one pen.
A higher dose of semaglutide is also marketed as Wegovy with a weight loss indication. Wegovy has a list price of $1,349.02 per package, which is a 28-day supply.
READ MORE: FDA Review Finds No Association Between GLP-1 Drugs and Suicidal Ideation
“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,” Martin Holst Lange, executive vice president for Development at Novo Nordisk, said in a press release.2
Company officials said that full results will be presented at a conference this year.
This follows the results of a separate trial, SELECT, announced last year. In that trial, the semaglutide product Wegovy 2.4 mg reduced the risk of major adverse cardiovascular events by 20% in adults who were overweight who had obesity.2 The trial enrolled 17,604 adults aged 45 years or older with obesity and established cardiovascular disease with no prior history of diabetes. These results were released at the American Heart Association Scientific Session meeting in November 2023.
Novo Nordisk has filed for a label update of Wegovy in both the United States and the Europea Union based on the SELECT study findings, and a decision is expected in 2024.
READ MORE: Diabetes Resource Center
This article originally appeared in Managed Healthcare Executive.
References
1. 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. News release. Novo Nordisk. 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 says Ozempic reduced risk of kidney problems by 24% in patients with type 2 diabetes. News release. Novo Nordisk. March 5, 2024. Accessed March 5, 2024. https://www.morningstar.com/news/marketwatch/20240305181/novo-nordisk-says-ozempic-reduced-risk-of-kidney-problems-by-24-in-patients-with-type-2-diabetes
