Game Changing Research Results
What is Semaglutide?
Semaglutide is a medication primarily used to treat type 2 diabetes and obesity. Semaglutide has been shown to reduce heart attacks and strokes in type 2 diabetes. It belongs to a class of drugs known as GLP-1 agonists, which work by mimicking the action of the incretin hormones the body naturally produces.
When blood sugar levels are high, semaglutide stimulates the pancreas to release insulin, which helps move sugar from the blood into the tissues where it is used for energy. It also lowers the amount of glucagon released, delays gastric emptying, and reduces appetite, contributing to weight loss. Semaglutide is available under brand names like Ozempic and Wegovy and is given by injection.
It is contraindicated for people at risk of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2, and type 1 diabetes. It can trigger diabetic ketoacidosis, pancreatitis, or heart failure.
What is the SELECT Trial?
The Select Trial randomized 17,604 patients from 41 countries who were overweight or obese with established cardiovascular disease and no history of diabetes. The patient received either weekly subcutaneous semaglutide (2.4 mg) or placebo.
The primary endpoint was a composite of death from cardiovascular causes, nonfatal MI or nonfatal stroke.
The primary endpoint occurred in 6.5% in the semaglutide group versus 8.0% with placebo (P<0.001), over a mean follow-up of 39.8 months. Death from Cardiovascular Causes, Death from All Causes and Heart Failure all tended to be less with semaglutide. Semaglutide reduced blood pressure, cholesterol, triglyceride, body weight and waist circumference compared with placebo.
A greater percentage of patients discontinued semaglutide, 16.6% vs. placebo, 8.2% (P<0.001), largely due to gastrointestinal symptoms.
The benefits of semaglutide were observed early. The event curves were separating in the first 6 months of treatment.
In Canada semaglutide is supplied in “pens” with 1.34 mg/mL concentration, designed for doses of 0.25, 0.5, or 1 mg. The largest capacity pens are 4 mg, approximately $250 PER PEN. The SELECT Trial used 2.4 mg. If one rounds the dose to 2 mg and uses the 4 mg pen – that would be around $125 per week, or $500 per month. The MB Health/Pharmacare criteria for coverage are quite restrictive, “For the treatment of type 2 diabetes in combination with metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and sulfonylurea do not achieve adequate glycemic control”. NIHB is more reasonable, however, coverage is uncertain if the patient is non-diabetic.
For many years weight loss was recommended to reduce risk of a secondary cardiovascular event including death, without any actual clinical trial proof or effective medication to achieve weight loss. The results of the SELECT Trial have finally provided the proof we need and a reliable method to achieve this goal.
There are three problems healthcare providers will be confronted by when considering the use of semaglutide for secondary prevention of cardiovascular events: the high cost of this proven therapy, the reluctance of patients to employ an injectable drug and the issue of adverse events. We will explore the latter in a future issue of The Pulse.
