Semaglutide, the compound in the blockbuster drugs Ozempic and Wegovy, significantly reduced the risk of kidney complications, heart problems and death in people with type 2 diabetes and chronic kidney disease in a major clinical trial whose results Results were released Friday. The findings could transform how doctors treat some of the sickest patients with chronic kidney disease, which affects more than one in seven adults in the United States but has no cure.
“Those of us who really care about kidney patients have spent our entire careers wanting something better,” said Dr. Katherine Tuttle, professor of medicine at the University of Washington School of Medicine and author of the study. “And it’s as good as it gets.” The research was presented Friday at a meeting of the European Renal Association in Stockholm and simultaneously published in the New England Journal of Medicine.
The trial, funded by Ozempic maker Novo Nordisk, was so successful that the company stopped it prematurely. Dr. Martin Holst Lange, Novo Nordisk’s executive vice president of development, said the company will ask the Food and Drug Administration to update Ozempic’s label to indicate that it can also be used for reduce the progression of chronic kidney disease or complications in people with type 2 diabetes.
Diabetes is a leading cause of chronic kidney failure, which occurs when the kidneys don’t work as well as they should. In advanced stages, the kidneys are so damaged that they cannot filter blood properly. This can cause a buildup of fluid and waste in the blood, which can exacerbate high blood pressure and increase the risk of heart disease and stroke, said Dr. Subramaniam Pennathur, head of the nephrology division of Michigan Medicine.
The study included 3,533 people with kidney disease and type 2 diabetes, about half of whom received a weekly injection of semaglutide and half of whom received a weekly injection of placebo.
The researchers followed the participants after a median period of about three and a half years and found that those who took semaglutide were 24 percent less likely to have major kidney disease, such as losing at least half of their kidney function or dialysis. or a kidney transplant. There were 331 such events in the semaglutide group, compared to 410 in the placebo group.
People who received semaglutide were much less likely to die from cardiovascular problems, or any cause, and had slower rates of kidney decline.
Kidney damage often occurs gradually, and people usually have no symptoms until the disease is in its advanced stages. Doctors try to slow the decline in kidney function with existing medications and lifestyle changes, said Dr. Melanie Hoenig, a nephrologist at Beth Israel Deaconess Medical Center, who was not involved in the study. But even with treatment, the disease can progress to the point that patients need dialysis, a treatment that removes waste and excess fluid from the blood, or a kidney transplant.
The study participants were extremely ill — the serious complications seen in some study participants are more likely to occur in people in the later stages of chronic kidney disease, said Dr. George Bakris, professor of medicine at the University of Chicago. author of the study. Most trial participants were already taking medications for chronic kidney disease.
For people with advanced kidney disease in particular, the results are promising. “We can help people live longer,” said Dr Vlado Perkovic, a nephrologist and kidney medicine researcher at the University of New South Wales in Sydney, and another author of the study.
Although the data shows clear benefits, even researchers studying drugs like Ozempic aren’t sure how they help the kidneys. One of the leading theories is that semaglutide may reduce inflammation, which would exacerbate kidney disease.
And the results come with several caveats: About two-thirds of the participants were men and about two-thirds were white — a limitation of the study, the authors noted, because chronic kidney disease disproportionately affects black patients and indigenous people. Trial participants taking semaglutide were more likely to stop the drug due to gastrointestinal problems, which are common side effects of Ozempic.
Doctors said they wanted to know whether the drug could benefit patients with kidney disease but not diabetes, and some also had questions about the potential long-term risks of taking semaglutide.
Still, the findings are the latest data showing that semaglutide may do more than treat diabetes or cause weight loss. In March, the FDA approved Wegovy to reduce the risk of cardiovascular problems in certain patients. And scientists are examining semaglutide and tirzepatide, the compound in rival drugs Mounjaro and Zepbound, for a range of other conditions, including sleep apnea and liver disease.
If the FDA approves the new use, it could lead to even more demand for Ozempic, which faces recurring shortages.
“I think it will be a game changer,” Dr. Hoenig said, “if I can offer it to my patients.”
News Source : www.nytimes.com
Gn Health
