Health Canada backs broader Ozempic use as trials link the drug to fewer heart attacks and strokes in type 2 diabetes
Heart attacks and strokes account for about 40 percent of heart attacks and 30 percent of strokes in people with type 2 diabetes in Canada, underscoring the cardiovascular burden of the disease.
Health Canada has approved a new indication for Ozempic (semaglutide injection) to reduce the risk of major adverse cardiovascular (CV) events – CV death, non-fatal myocardial infarction or non-fatal stroke – in adults with type 2 diabetes mellitus and established cardiovascular disease and/or chronic kidney disease.
Health Canada based this decision on a pooled analysis of SUSTAIN 6, PIONEER 6, FLOW and SOUL, which showed that treatment with Ozempic reduced the risk of major adverse cardiovascular events (MACE) compared to placebo when added to standard of care.
Lawrence Leiter, professor of medicine at the University of Toronto and co-author of the SUSTAIN 6 trial, said “adults with type 2 diabetes face a substantially higher risk of heart attacks and other major cardiovascular events than the general population.”
He said trials like SUSTAIN 6 have “fundamentally changed the management of diabetes,” showing that semaglutide can “meaningfully reduce the risk of major cardiovascular events, including heart attacks and non-fatal strokes.”
He called this “an important advance for persons living with diabetes and their families.”
In SUSTAIN 6, a 104-week, randomised, double-blind, placebo-controlled cardiovascular outcomes trial, 3,297 adults with type 2 diabetes and high cardiovascular risk received once-weekly Ozempic 0.5 mg or 1 mg, or placebo, in addition to standard of care.
The primary objective was to confirm that semaglutide does not result in any unacceptable increase in cardiovascular risk compared to placebo, assessed as time to first MACE (CV death, non-fatal myocardial infarction or non-fatal stroke).
FLOW was a multi-centre, multi-national, randomised, placebo-controlled, double-blind, parallel-group, event driven trial in adults with type 2 diabetes and chronic kidney disease.
In this study, 3,533 patients received Ozempic 1 mg once weekly or placebo and were followed for a median of 40.9 months.
The primary objective was to demonstrate that Ozempic delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo, both added to standard-of-care, in subjects with type 2 diabetes and chronic kidney disease.
SOUL, a randomised, double-blind, parallel-group, placebo-controlled trial in 9,650 patients with type 2 diabetes mellitus and established cardiovascular disease and/or chronic kidney disease, compared the risk of MACE between oral semaglutide 14 mg once daily and placebo when both were used with standard of care.
Ozempic, first approved by Health Canada in 2018, is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycaemic control.
It can be used with metformin, sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) and basal insulin with metformin.
Ozempic is also indicated as an adjunct to diet, exercise and standard of care to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease, and to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
