Health Canada has approved Ozempic to help reduce the risk of kidney deterioration in adults with Type 2 diabetes. This decision comes as studies indicate that between 30% and 50% of individuals with Type 2 diabetes develop chronic kidney disease.
The approval is based on findings from an international clinical trial known as FLOW. This study revealed that patients taking Ozempic had a 24% lower risk of significant kidney decline or failure compared to those receiving a placebo. Additionally, those on Ozempic were less likely to die from cardiovascular disease, a common concern among diabetes patients.
Dr. David Cherney, a nephrologist at Toronto General Hospital, played a key role in the Canadian segment of the trial. He emphasized the importance of these results, stating, "What my patients are scared of is dialysis — dialysis or a transplant. I can reasonably reduce that risk and thereby reduce their anxiety and fear of serious, serious complications."
Dr. Ehud Ur, an endocrinologist at the University of British Columbia, praised the approval as "great news" for diabetes management. He noted, "The prevention of kidney disease is a very important goal in the management of patients with Type 2 diabetes and this is another tool."
Ozempic, which is an injectable form of semaglutide, was initially approved in Canada as a diabetes medication due to its ability to lower blood sugar levels. It also aids in weight loss and is marketed under the name Wegovy for obesity treatment at higher doses.
Health Canada confirmed that the approval, granted on August 13, allows 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. The eGFR is a critical measure of kidney function, indicating how effectively the kidneys filter waste and excess water.
Ozempic is the first GLP-1 drug approved in Canada that offers protection for both the kidneys and the heart in Type 2 diabetes patients. Dr. Ur highlighted the dual benefits, stating, "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."
While some patients may experience gastrointestinal side effects such as nausea, vomiting, constipation, and diarrhea, Dr. Ur noted that most side effects are minor. He believes that the advantages of slowing or halting kidney disease progression outweigh the risks associated with these side effects.
The FLOW trial involved 3,533 participants from 28 countries, including Canada. Researchers monitored these individuals for an average of 3.4 years to assess major kidney disease events, including kidney failure requiring dialysis or transplantation, a 50% reduction in kidney function, or death from kidney-related or cardiovascular causes. Participants received either Ozempic or a placebo alongside their existing medications for blood pressure and blood sugar control.
Dr. Cherney remarked on the significance of Ozempic, stating, "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."
Dr. Ur suggested that Ozempic might also help reduce inflammation in the kidneys, which could explain its beneficial effects. He emphasized the importance of using the drug early in the disease process to minimize kidney damage in individuals with Type 2 diabetes.