Health Canada approves Ozempic to reduce kidney deterioration in people with diabetes

Health Canada has approved Ozempic to reduce the risk of further kidney decline among patients with Type 2 diabetes.

Between 30 and 50 per cent of people with Type 2 diabetes develop some form of chronic kidney disease.

An international clinical trial, called FLOW, showed the risk of kidneys significantly deteriorating or failing was 24 per cent lower in patients taking Ozempic compared to those taking a placebo injection.

The patients taking the drug were also less likely to die from cardiovascular disease another condition that affects many patients with diabetes.

The study, funded by Ozempic manufacturer Novo Nordisk, was peer-reviewed and published in the New England Journal of Medicine last year and contributed to Health Canada's decision.

Dr. David Cherney, a nephrologist at Toronto General Hospital, helped lead the Canadian part of the trial and says the results show it's possible to reduce the loss of kidney function before patients need dialysis or a kidney transplant.

"What my patients are scared of is dialysis — dialysis or a transplant," said Cherney, who is also a senior scientist at the Toronto General Hospital Research Institute, in an interview.

"I can reasonably reduce that risk and thereby reduce their anxiety and fear of serious, serious complications. Not to mention all the cardiovascular disease, which patients are also extremely afraid of."

Dr. Ehud Ur, an endocrinologist in Vancouver who was not involved in the study, said the results are credible and that Health Canada's approval of Ozempic to help prevent kidney decline is "great news."

"The prevention of kidney disease is a very important goal in the management of patients with Type 2 diabetes and this is another tool," said Ur, who is a professor of endocrinology and metabolism at the University of British Columbia.

Ozempic is the brand name of an injectable dose of semaglutide, a glucagon-like peptide-1 (GLP-1) hormone. Ozempic was first approved in Canada as a diabetes medication because it reduces blood sugar. It can also decrease appetite and has been approved as a weight-loss drug for people with obesity at a higher dose under the brand name Wegovy, which is also manufactured by Novo Nordisk.

In an email, Health Canada confirmed to The Canadian Press that on Aug. 13, it had approved Ozempic "to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease and cardiovascular death in adults with Type 2 diabetes and chronic kidney disease."

Glomerular filtration rate is a measure that shows how well the kidneys are filtering out waste and excess water.

Ozempic is the firstGLP-1 drug approved in Canada to protect both kidneys and the heart in patients with Type 2 diabetes, said Ur, noting that the cardiovascular benefits of semaglutide have been extensively studied.

"The benefit of Ozempic is that you also get weight loss, which is a very important goal for most people (with Type 2 diabetes). That's a very exciting combination," he said.

Some people experience gastrointestinal side effects when they take Ozempic, Ur said, including nausea, vomiting, constipation and diarrhea.

More severe complications can include gall bladder inflammation and pancreatitis, but most side effects are minor, he said.

The benefit of slowing or stopping progressive kidney disease in people with diabetes would outweigh the risks of minor side effects, Ur said.

The FLOW trial was conducted in 28 countries, including Canada. The researchers randomized 3,533 people with diabetes and chronic kidney disease to either receive Ozempic or a placebo. The study was conducted between 2019 and early 2024.

Participants were followed for an average of 3.4 years to monitor for "major kidney disease events," including kidney failure leading to dialysis or transplantation, a 50-per-cent reduction in kidney function measured by glomerular filtration rate, or death from kidney-related or cardiovascular causes.

The Ozempic or placebo doses were given to participants on top of other medications they were taking, including drugs to control blood pressure and blood sugar.

Although reducing blood pressure and blood sugar have beneficial effects for the kidneys, Cherney said Ozempic appeared to have an additional positive impact on kidney function and future research can help pinpoint how that works.

"Another weapon against kidney disease is incredibly powerful. And these medicines will often turn patients around who are doing very poorly because it addresses so many different issues — the kidney, the cardiovascular, the metabolic, and the weight," said Cherney.

Ur said it's possible Ozempic could play a role in reducing inflammation in the kidneys and that might be one explanation for its positive effect.

Regardless of the reason for its effectiveness, he said the FLOW trial and Health Canada's approval reinforces the importance of using the drug "relatively early in the disease process" to minimize kidney damage in people with Type 2 diabetes.