Ozempic Now FDA-Approved for Kidney Disease—Here's What to Know

Yahoo

13-02-2025

GLP-1 medications are renowned for their ability to treat type 2 diabetes and aid weight loss. Now, there's a new benefit to taking Ozempic: It may help manage chronic kidney disease (CKD). On January 28, the U.S. Food and Drug Administration (FDA) approved the GLP-1 drug to reduce the risk of kidney disease worsening into kidney failure after the success of a clinical trial. To learn more about the effects of Ozempic on chronic kidney disease, keep scrolling.
The FLOW phase 3b kidney outcomes trial, which was published in The New England Journal of Medicine, was trying to solve the problem of diabetes being a risk factor for kidney disease by using semaglutide.
According to Richard E. Pratley, MD, medical director at the AdventHealth Diabetes Institute in Orlando, FL, and co-chair of the FLOW clinical trial, there have been new classes of medications released in the last several years to slow down kidney disease progression. While he says these have been helpful, many people still progress to kidney failure.
Before the FLOW trial, various studies demonstrated that 'drugs like liraglutide, semaglutide and dulaglutide were effective at reducing the risk for cardiovascular events such as heart attacks, strokes and cardiovascular death,' says Dr. Pratley, 'But they also seem to indicate that there is a benefit on kidney disease progression.'
Those studies weren't meant for kidney disease and had very few patients with the condition. However, they jump-started the need to look into the effects of those drugs as a way to help treat CKD.
The FLOW trial began in 2019 as a global study with about 3,500 participants from 28 countries who had a median age of 65. 'Everyone was randomized to semaglutide or a placebo, all had chronic kidney disease or specific criteria and all had type 2 diabetes,' says Dr. Pratley. In addition to taking Ozempic, patients were also being treated with medication to manage high blood pressure, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs).
After more than three years, 'There was about a 24 percent reduction in progression of chronic kidney disease,' says Dr. Pratley. That includes 'kidney failure, progression of the EGFR decline and also cardiovascular death.'
How else did Ozempic help people with diabetes and kidney disease? Kidney failure, a decline in kidney function and incidences of death were significantly reduced. Dr. Pratley adds that the risk for major adverse cardiovascular events also decreased significantly.
Before Ozempic was developed, Dr. Pratley explains that other studies used SGLT 2 inhibitors for CKD and showed benefits in patients who didn't have diabetes. However, 'there is no comparable data with the semaglutide. At the moment, the label is just for people with type 2 diabetes and chronic kidney disease,' he says. That means Ozempic is not FDA-approved to treat chronic kidney disease on its own. Dr. Pratley advises talking to your doctor about treatment options but hopes that more studies will demonstrate the benefits of Ozempic for those with CKD.
Results of the FLOW trial showed a reduction in glucose and A1C levels, as well as some evidence for reductions in lipid values, LDL, total cholesterol and blood pressure. But Dr. Pratley says that none of these things are able to fully explain the benefit of GLP-1 drugs for CKD. 'We think it's more likely to be a direct mechanism that perhaps has something to do with inflammation,' he explains. 'There is evidence for decreased inflammation following treatment, and the C-reactive protein levels are about 50 percent lower.'
While semaglutide has shown promise in treating patients with chronic kidney disease and type 2 diabetes, Novo Nordisk is continuing its research. The drug manufacturer is currently conducting a different study to understand the exact ways that GLP-1 drugs can reduce CKD risks.
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