What the indication says
Section 1 of the US label lists the cardiovascular use first, for both Wegovy® injection and Wegovy® tablets. It covers adults who already have cardiovascular disease and who also have obesity or overweight, and aims to lower the risk of a group of serious events called MACE: death from a cardiovascular cause, a heart attack that is not fatal, or a stroke that is not fatal [1].
The Medication Guide puts it in everyday words: for adults with known heart disease, the medicine is used to reduce the risk of events such as death, heart attack or stroke. It is used with a reduced-calorie diet and more activity, not in place of other heart care, and the guide says it is not known whether it is safe and effective for this purpose in people under 18 [1].
Three regulators, one trial
The European Medicines Agency and Health Canada reviewed the same SELECT data and reached different wording. The table summarises the documents checked on 20 October 2026.
| Document | Cardiovascular wording | Where |
|---|---|---|
| Wegovy®, US prescribing information, revised 06/2026 [1] | Reduce the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease and obesity or overweight (injection and tablets) | Section 1; trial in 14.1 |
| Wegovy®, EU product information [2] | No separate indication; the weight-management indication refers to section 5.1 for cardiovascular risk-reduction results | Sections 4.1 and 5.1 |
| Wegovy®, Canadian product monograph, authorized 10 December 2025 [3] | Reduce the risk of non-fatal myocardial infarction in adults with established cardiovascular disease and a BMI of 27 or more | Section 1; trial in section 14 |
Who was in SELECT
SELECT enrolled adults aged 45 or older with a BMI of 27 or more and established cardiovascular disease, meaning a previous heart attack, a previous stroke or peripheral arterial disease. People with type 1 or type 2 diabetes were excluded [1].
In the label’s description, the average age was 62 and 72% were men. A previous heart attack was reported by 76%, a previous stroke by 23% and peripheral arterial disease by 9%; 24% had heart failure, and 10% had moderately reduced kidney function. Most were already on heart medicines: 90% on lipid-lowering treatment, 86% on platelet inhibitors, 74% on blood-pressure medicines of the ACE inhibitor or angiotensin receptor blocker type and 70% on beta blockers [1].
How the trial was run
Participants were randomly assigned to weekly semaglutide injection or placebo on top of their usual care, which included management of risk factors and healthy-lifestyle counselling. The dose was raised over 16 weeks towards 2.4 mg, and people who could not tolerate the full schedule could stay on a lower dose. Of those still on treatment at one year, 76% were taking 2.4 mg, 8% 1.7 mg and 16% a lower dose [1].
The trial counted time to the first MACE event. The published summary reports a mean follow-up of 39.8 months; the label gives a median of 41.8 months, and vital status was known for 99.4% of participants [1][4].
The main result, line by line
A first MACE event occurred in 569 of 8,803 people on semaglutide (6.5%) and 701 of 8,801 on placebo (8.0%). The hazard ratio of 0.80 means the risk of a first event was about 20% lower with semaglutide over the trial period. The label adds that the reduction was not affected by age, sex, race, ethnicity, starting BMI or level of kidney impairment [1].
The footnotes matter as much as the numbers. Only the first line was the confirmed primary result; the others were either tested in a fixed order that stopped early or were never part of the formal testing plan [1].
| Outcome | Placebo | Wegovy® injection | Hazard ratio (95% CI) | Label footnote |
|---|---|---|---|---|
| Cardiovascular death, non-fatal heart attack or non-fatal stroke [1] | 8.0% | 6.5% | 0.80 (0.72 to 0.90) | Primary endpoint, confirmed |
| Cardiovascular death | 3% | 2.5% | 0.85 (0.71 to 1.01) | Superiority not confirmed |
| Death from any cause | 5.2% | 4.3% | 0.81 (0.71 to 0.93) | Not significant under the testing order |
| Fatal or non-fatal heart attack | 3.8% | 2.8% | 0.72 (0.61 to 0.85) | Outside the testing plan |
| Fatal or non-fatal stroke | 2% | 1.8% | 0.89 (0.72 to 1.11) | Outside the testing plan |
| Heart failure hospitalisation or urgent visit | 1.4% | 1.1% | 0.79 (0.60 to 1.03) | Effect on heart failure not established |
What else changed by week 104
The label reports average changes at two years that were outside the formal testing plan. Body weight fell by 9.4% on semaglutide and 0.9% on placebo. Systolic blood pressure fell by 3.8 mmHg against 0.5 mmHg, and HbA1c, which started at 5.8%, fell by 0.3 percentage points against no change. Resting heart rate rose by 3.8 beats per minute against 0.7 [1].
Researchers have not established exactly how semaglutide lowers cardiovascular risk; the label says so directly in its mechanism section [1]. Weight loss, blood pressure and other changes may each play a part, but the trial was not designed to separate them.
Side effects and safety findings in SELECT
Safety data in SELECT were limited to serious events, events leading to stopping and events of special interest. Side effects led 16% on semaglutide and 8% on placebo to stop the study drug; counting every reason, 31% and 27% stopped permanently [1]. The published summary gives 16.6% and 8.2% for stopping because of side effects [4].
- Fractures: more hip and pelvis fractures on semaglutide in women (1% versus 0.2%) and in people aged 75 or older (2.4% versus 0.6%) [1].
- Kidney stones: reported in 1.2% versus 0.8%, with serious cases slightly more frequent on semaglutide [1].
- Low blood sugar: three serious episodes on semaglutide and one on placebo; people with a history of bariatric surgery had more [1].
- Heart rate: section 5.9 asks prescribers to check heart rate regularly and asks you to report a racing or pounding heartbeat at rest [1].
- Older adults: effectiveness did not differ by age, but people aged 75 or older reported more serious adverse reactions overall [1].
The dose, the tablets and the other labels
For cardiovascular risk reduction, section 2.2 lists a maintenance dose of the injection of 2.4 mg weekly (recommended) or 1.7 mg, chosen by response and tolerability; the higher 7.2 mg dose in the same section is described for weight reduction only. For the tablets, section 2.3 gives a maintenance dose of 25 mg once daily for both uses, and section 2.5 describes switching between the two forms [1]. Which form and dose fits you is your prescriber’s decision.
SELECT itself used the injection [1]. Ozempic® carries its own cardiovascular indication for adults with type 2 diabetes and established cardiovascular disease, based on SUSTAIN 6, and Rybelsus® and Ozempic® tablets have one for adults with type 2 diabetes at high risk [5][6]. The EU product information also describes two heart-failure trials, STEP-HFpEF and STEP-HFpEF-DM, in which symptoms and walking distance improved, and notes that people with the most severe heart failure, NYHA class IV, were not studied [2].
Wegovy®, Ozempic® and Rybelsus® are registered trademarks of Novo Nordisk A/S. PepLabo is not affiliated with or endorsed by Novo Nordisk.
When to get help
| Sign | Who to contact | How fast | Source |
|---|---|---|---|
| Chest pressure, squeezing or pain lasting more than a few minutes, or sudden shortness of breath | Emergency services (911 or your local number), even if unsure | Emergency | MedlinePlus [7] |
| Sudden weakness or numbness on one side, trouble speaking, sudden vision loss or a sudden severe headache | Emergency services (911 or your local number) | Emergency | MedlinePlus [8] |
| A racing or pounding heartbeat at rest that lasts | Your prescriber | Today | US label, sections 5.9 and 17; Medication Guide [1] |
| Questions about whether the heart indication applies to you, or how it fits with your other heart medicines | Your prescriber or cardiologist | At your next appointment | US label, section 1 [1] |
