Study finds Ozempic reduces risk of serious illness and death in people with diabetes and kidney disease

CNN
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A weekly injection of semaglutide medication such as Ozempic significantly reduces the risk of serious kidney disease, major cardiovascular events and death in people with type 2 diabetes and chronic kidney disease, according to a new study.

Diabetes is a significant risk factor for kidney disease, a leading cause of death in the United States and around the world, and about one in three people with diabetes also has chronic kidney disease, according to the U.S. Centers for Disease Control and Prevention.

But new research shows that weekly injections of semaglutide reduce the risk of serious outcomes from diabetic kidney disease by about 24%.

These serious outcomes, including a significant decline in kidney function, kidney failure and death from kidney or cardiovascular disease, occurred 331 times in study participants who received semaglutide compared to 410 times in those who received placebo. Scaled by the number of years each person was in the study, participants who received semaglutide experienced 5.8 events per 100 years of follow-up compared to 7.5 events per 100 years of follow-up in participants who received placebo.

High blood sugar levels in people with diabetes can damage blood vessels in the kidneys and put strain on the heart, and a new study has found a more far-reaching associated effect of semaglutide treatment for people with diabetic kidney disease.

The decline in kidney function was slower overall, and the risk of major cardiovascular events such as heart attack was reduced by 18%, and the risk of death from any cause was reduced by 20%. The study compared people who received semaglutide with people who received a placebo.

The study, published Friday in the New England Journal of Medicine and presented at the European Society of Nephrology, was based on results from a drug trial of nearly 3,500 people in 28 countries with both type 2 diabetes and kidney disease. About half of the participants received weekly injections of 1 milligram of semaglutide — the dose approved in the United States under the brand name Ozempic to treat type 2 diabetes — and the rest received a placebo.

Overall, study participants were followed for an average of about three and a half years. The trial was originally expected to last four to five years, but results from mid-term check-ins were so promising that an independent monitoring committee recommended ending the trial early.

“This trial has shown the benefit of semaglutide, demonstrating how it can make a difference for people with diabetes and kidney disease,” said Dr Vlado Perkovic, a nephrologist and chair of the department at the University of New South Wales, Sydney, who was chair of the trial steering committee and lead author of the new study.

“The effect size was a little bit larger than expected, so the results were highly statistically significant. So it's highly unlikely that this is a chance finding, and I think we can be confident that the results are robust and real.”

Three other drug treatments have been shown to be effective for patients with diabetic kidney disease, and the researchers note in the new study that “clinicians and patients need to consider the sequence and priority of semaglutide's use.”

Combinations of treatments can be important, and many of the study participants were also receiving other types of treatment for their diabetes.

“Semaglutide showed several benefits over and above what is currently considered the standard of care,” said Martin-Horst Lange, executive vice president of development at Novo Nordisk. The Danish company is the only drugmaker that makes semaglutide products approved for use in the U.S. — Ozempic for treating diabetes and Wegovy for obesity — and funded the new study.

Similar benefits were seen across all levels of starting kidney function, with a particular focus on those at highest risk: According to risk calculations outlined in global clinical practice, more than two-thirds of study participants were considered at very high risk of serious outcomes, including kidney failure, cardiovascular events, or death. Guidelines.

Focusing on this high-risk group could help doctors understand the benefits of treatment more clearly. But experts say many people don't realize they have kidney disease until it's advanced, and many don't realize how dangerous it can be. Over the course of the study's first year, about 8% of participants developed serious kidney problems and about 5% died.

“Diabetes-related kidney disease, or diabetic kidney disease, is one of the most common and deadliest complications of diabetes, yet unfortunately, awareness of the disease is very low,” says Dr. Katherine Tuttle, chair of the American Society of Nephrology's Diabetic Kidney Disease Collaborative. Dr. Tuttle is also executive director of research at Providence Inland Northwest Health, a research fellow at the Translational Health Sciences Institute, and a professor of medicine at the University of Washington.

“Part of the problem is that doctors and patients have to be very vigilant about identifying kidney disease because the disease is asymptomatic until the late stages.”

People with diabetes are recommended to get tested for kidney disease with blood or urine tests every six months, but this is not always done and some people wait until they experience symptoms such as fatigue, swelling or changes in urination frequency.

Diabetes medications are in high demand because it's such a common disease, said Tuttle, who also participated in the new study. But semaglutide is promising because it appears to help with several complications that can arise from diabetes. In addition to lowering blood sugar levels, semaglutide products have also been shown to aid in weight loss. heart failure and potentially inhibiting Addictive behavior.

“I think these drugs that act on multiple final common pathways are very effective because if you try to treat just one risk factor, it's like putting your finger in a dyke – you can't plug all the holes. To me, the real benefit of semaglutide is that it addresses a broad range of risk,” she said. “It helps you lose weight, it helps lower your blood sugar, it helps lower your blood pressure a little bit, and then it has a direct effect on the kidneys. It's really a holistic effect.”

There are large disparities in the prevalence of diabetes and kidney disease in the U.S. According to the CDC, black, Hispanic and Native American adults are nearly twice as likely to have diabetes as white adults. dataAnd black Americans are about three times more likely to develop kidney failure than white adults.

However, most participants in the semaglutide trial were white, and the results could not be assessed across important subgroups.

“Once we find effective treatments, we have to look at getting them to patients,” Tuttle says. But many of the most at-risk people who could benefit most from treatment don't have access to it.

“We now have highly effective treatments that alleviate the issues that really matter to patients, families and communities: preserving kidney function, preserving life and reducing the incidence of cardiovascular events. But that's great once people have the treatment,” she said. “So the challenge that we all face now is to go from evidence generation to implementation much more quickly.”