The Scottish Medicines Consortium (SMC) has accepted semaglutide (Wegovy, Novo Nordisk) for use in NHS Scotland to reduce cardiovascular risk in adults with established cardiovascular disease who are overweight or obese.
The weekly subcutaneous injection was accepted as an adjunct to a reduced-calorie diet and increased physical activity. It is indicated specifically to lower the risk for major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, in patients with a BMI of 27 or higher.
The decision gives clinicians in Scotland another option for secondary prevention in a population already at high cardiovascular risk, extending semaglutide’s role beyond weight management alone. In the SMC’s June decisions release, SMC Chair Dr Rob Peel said semaglutide would provide “a useful treatment option” to help reduce major cardiovascular events in patients who are overweight and have cardiovascular disease.
A New Role in Cardiovascular Prevention
Cardiovascular disease causes more than one quarter of all deaths in Scotland and is the second most common cause of mortality after cancer. Individuals with BMI greater than 30 face a markedly elevated risk for diabetes and two- to threefold higher risk for coronary heart disease and stroke compared with those with normal BMI.
Current cardiovascular risk reduction strategies include lifestyle interventions, such as physical activity, dietary modification, weight management, smoking cessation, and reduced alcohol intake, as well as pharmacological treatments, including antihypertensives, statins, and antiplatelet agents.
Semaglutide previously received SMC acceptance for weight management in adults with BMI of 30 or higher and at least one weight-related comorbidity, requiring treatment within specialist weight management services. This new indication extends its use specifically for cardiovascular protection in patients with established cardiovascular disease.
Semaglutide is a GLP-1 receptor agonist, targeting appetite-regulating brain receptors while modulating insulin and glucagon secretion based on blood glucose levels. The precise mechanism underlying its cardiovascular benefit remains under investigation and may extend beyond weight loss alone.
Evidence From SELECT
The decision was supported by evidence from the phase 3 SELECT trial, which enrolled 17,604 patients aged 45 years or older with established cardiovascular disease and a BMI of 27 or higher. Eligible patients had a history of myocardial infarction, stroke, or symptomatic peripheral arterial disease, but no diabetes.
Patients received once-weekly subcutaneous semaglutide 2.4 mg or placebo, in addition to standard cardiovascular care, for a mean duration of 33 months.
The primary cardiovascular endpoint — a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke — occurred in 6.5% of patients receiving semaglutide and 8.0% of those receiving placebo. This represented a 20% relative risk reduction (hazard ratio, 0.80; P < .001) over a mean follow-up of 39.8 months.
Patients receiving semaglutide also had greater weight loss than those receiving placebo. At 2 years, mean body weight had fallen by 9.4% in the semaglutide group, compared with 0.9% in the placebo group.
Safety Considerations
No unexpected safety signals were reported when semaglutide was added to standard cardiovascular care. Treatment-emergent adverse events occurred in 71% of patients receiving semaglutide and 67% of those receiving placebo.
Permanent discontinuation due to adverse events was more common with semaglutide (17%) than with placebo (8.2%). Gastrointestinal disorders were the main reason for discontinuation, accounting for 10% of treatment stops in the semaglutide group and 2.0% in the placebo group.
These findings reinforce the need for careful dose escalation and counselling about gastrointestinal adverse effects, particularly in patients who are already receiving multiple cardiovascular medicines.
Dosing, Cost, and Implementation
Semaglutide is administered once weekly by subcutaneous injection. Treatment is started at 0.25 mg weekly and gradually escalated over 16 weeks to the maintenance dose of 2.4 mg, a schedule intended to reduce gastrointestinal symptoms during initiation.
The drug will be distributed as Wegovy in pre-filled subcutaneous injection pens. The list price in the UK is £1926 for the first year of treatment and £2285 in subsequent years, although additional discounts apply through a confidential national patient access scheme.
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