Ozempic Approved for Heart Protection

Health Canada's approval on March 2, 2026, was underpinned by a pooled analysis of four major clinical trials: SUSTAIN 6, PIONEER 6, FLOW, and SOUL. These studies collectively demonstrated that semaglutide, the active ingredient in Ozempic, significantly reduces the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular or chronic kidney disease. The SUSTAIN 6 trial, a key piece of evidence, showed a 26% reduction in the risk of the primary composite outcome of cardiovascular death, non-fatal heart attack, or non-fatal stroke over two years. This was largely driven by a significant 39% decrease in the rate of non-fatal strokes. More recent evidence from the FLOW trial reinforced these findings, showing an 18% reduction in major cardiac events and a 20% lower risk of death from any cause for patients taking Ozempic. The SOUL trial, which studied an oral version of semaglutide, also showed a 14% reduction in major adverse cardiovascular events. This cardiovascular indication marks the third major approval for Ozempic in Canada. The drug was first approved in 2018 for improving glycemic control in adults with type 2 diabetes. This was followed in August 2025 by an approval to reduce the risk of kidney disease progression, based on the positive outcomes of the FLOW trial. The heart-protective benefits of semaglutide are believed to extend beyond weight loss and blood sugar control. Research suggests the drug has anti-inflammatory effects and may directly improve the function of blood vessels and the heart muscle itself. This multifaceted mechanism contributes to its effectiveness in reducing cardiovascular risk. Ozempic joins a growing class of diabetes medications with proven cardiovascular benefits. In Canada, other GLP-1 receptor agonists like Victoza (liraglutide) and Trulicity (dulaglutide) have also been approved to reduce cardiovascular risks. Health Canada approved Victoza for reducing the risk of cardiovascular death in November 2017, and Trulicity was approved in September 2020 to lower the risk of non-fatal stroke.