In patients with type 2 diabetes and high cardiovascular risk, once-weekly semaglutide significantly reduced the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) compared to placebo, though it was associated with a higher risk of diabetic retinopathy complications.
PICO Summary
Population:
Patients with type 2 diabetes (n=3297), aged ≥50 years with established cardiovascular disease or chronic kidney disease, or aged ≥60 years with additional cardiovascular risk factors.
Intervention:
Once-weekly subcutaneous semaglutide, 0.5 mg or 1.0 mg, administered over 104 weeks.
Comparison:
Placebo (once-weekly, volume-matched).
Outcome:
- Efficacy: Semaglutide reduced the primary composite cardiovascular endpoint by 26% (hazard ratio, 0.74) and specifically lowered the risk of nonfatal stroke by 39%.
- Safety and Tolerability: Higher incidence of diabetic retinopathy complications in semaglutide group (hazard ratio, 1.76), along with common gastrointestinal side effects.
Clinical Summary
Main Finding:
Semaglutide significantly lowers cardiovascular event risk in high-risk patients with type 2 diabetes.
Clinical Relevance:
This study supports semaglutide’s potential as a dual-purpose therapy for glycaemic control and cardiovascular risk reduction, although careful monitoring for diabetic retinopathy complications is advised.
Study Overview:
- Type of Study: Randomised, double-blind, placebo-controlled trial.
- Sample Size & Population: 3297 patients with type 2 diabetes at elevated cardiovascular risk.
- Intervention Duration & Doses: 104-week treatment with semaglutide (0.5 mg or 1.0 mg weekly).
- Comparison: Placebo.
Outcomes:
- Primary Measure (Cardiovascular Events): Semaglutide reduced cardiovascular event risk by 26% vs. placebo.
- Secondary Measures: Reduced nonfatal stroke risk by 39%; weight and HbA1c reductions were significantly greater in the semaglutide group.
- Safety Profile: Increased risk of retinopathy complications in semaglutide group; similar hypoglycemia rates to placebo.
Considerations:
The increased retinopathy risk warrants caution, particularly in patients with existing retinopathy. Further research could assess this association and refine patient selection criteria.
Reference:
Marso, S. P., et al. (2016). New England Journal of Medicine, 375(19), 1834-1844. doi:10.1056/NEJMoa1607141
Disclosure: This article on Hormone Insight was created with both human and AI assistance. The human expert editor reviewed the article before publication to ensure accuracy, quality, and clarity.
