From the FDA Drug Label
The SUSTAIN 6 (NCT01720446) was a multi-center, multi-national, placebo-controlled, double-blind cardiovascular outcomes trial. In this trial, 3,297 patients with inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease were randomized to OZEMPIC(0. 5 mg or 1 mg) once weekly or placebo for a minimum observation time of 2 years. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke OZEMPIC significantly reduced the occurrence of MACE. The estimated hazard ratio for time to first MACE was 0.74 (95% CI: 0.58,0. 95).
The SUSTAIN-6 study demonstrated that semaglutide significantly reduced the risk of Major Adverse Cardiovascular Events (MACE) in patients with type 2 diabetes and atherosclerotic cardiovascular disease. The study showed a hazard ratio of 0.74 for time to first MACE, indicating a 26% reduction in the risk of MACE compared to placebo 1.
- Key findings include:
- Reduced risk of non-fatal myocardial infarction
- Reduced risk of non-fatal stroke
- No significant reduction in cardiovascular death The study provides evidence for the cardiovascular benefits of semaglutide in patients with type 2 diabetes and established cardiovascular disease 1.
From the Research
Semaglutide is a highly effective treatment for type 2 diabetes that significantly reduces cardiovascular risk, with the most recent and highest quality study 2 demonstrating its benefits across all age subgroups. The SUSTAIN-6 trial, a randomized, double-blind, placebo-controlled trial, evaluated 3,297 patients who received either semaglutide (0.5 mg or 1.0 mg) or placebo as weekly subcutaneous injections for 104 weeks. The primary outcome showed a 26% reduction in the composite endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke with semaglutide compared to placebo. Notably, this benefit was primarily driven by a significant 39% reduction in nonfatal stroke and a 26% reduction in nonfatal myocardial infarction, while cardiovascular death rates were similar between groups. Some key points to consider when prescribing semaglutide include:
- Its ability to reduce major adverse cardiovascular events (MACE) across all subgroups, including those with established cardiovascular disease or high cardiovascular risk 3
- Its benefits for glycemic control, with an HbA1c reduction of 0.7-1.0% and weight loss of 3.6-4.9 kg compared to placebo 3
- Its safety profile, with the most common adverse effects being gastrointestinal, including nausea, vomiting, and diarrhea 3
- Its potential to provide cardiovascular benefits in people with type 2 diabetes and at high cardiovascular risk across a broad spectrum of kidney function and damage 4
- Its consistent reduction in MACE risk across age subgroups, with no significant difference in safety profile between age groups 2
Overall, semaglutide is a valuable treatment option for type 2 diabetes patients with established cardiovascular disease or high cardiovascular risk, offering cardiovascular protection beyond glycemic control.