The once-daily pill offers new oral cardiovascular risk-reduction option for plan members with diabetes
Heart disease is still the second leading cause of death in Canada, and most Canadians have at least one risk factor – now a once‑daily GLP‑1 pill adds a new option for adults with type 2 diabetes and cardiovascular risk.
Health Canada has approved RYBELSUS (semaglutide tablets) to reduce major adverse cardiovascular events – cardiovascular death, non‑fatal myocardial infarction or non‑fatal stroke – in adults with type 2 diabetes who have established cardiovascular disease or are at high risk for these events.
The company says the decision is based on the SOUL trial, which showed that RYBELSUS lowered the risk of these events compared with placebo when added to standard diabetes and cardiovascular care.
RYBELSUS is a glucagon‑like peptide‑1 (GLP‑1) drug, the same class as Ozempic and Wegovy, but in pill form.
Global News reports that this is the first GLP‑1 pill approved in Canada and that all other GLP‑1 therapies available in the country to date are injectables.
According to the RYBELSUS website, the pill works along with diet and exercise to improve blood sugar in adults with type 2 diabetes and can “reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus who are at high risk for these events.”
At the same time, the durability of GLP‑1 benefits depends on ongoing use.
A review of 63 trials involving more than 9,000 people, published in the British Medical Journal and cited by Global News, found that patients on weight‑loss drugs regained weight at an average of 0.4 kilograms per month after stopping treatment.
It also found that when patients regained the lost weight, the cardiovascular benefits of GLP‑1 therapy disappeared.
Global News also reports that the US Food and Drug Administration has approved a once‑daily Wegovy pill for weight loss, with Novo Nordisk applying to bring an oral Wegovy formulation to Canada.
For now, the Canadian approval for RYBELSUS applies only to adults with type 2 diabetes who also have cardiovascular disease or are at high risk of heart disease.
Commenting on oral GLP‑1 therapy more broadly, Fahad Razak of St. Michael’s Hospital and the University of Toronto told Global News that while “the oral pill offers convenience, that may come at the expense of effectiveness.”
Novo Nordisk advises patients to speak with their doctor about potential side effects before starting RYBELSUS and positions the drug as part of a broader regimen that includes diet, exercise and standard cardiovascular and diabetes care.
