SUSTAIN-6

Trial to Evaluate CV and Other Long-term Outcomes with Semaglutide

Patient / Population Intervention / Exposure Comparison Outcome

In 3,297 patients with T2DM at high CV risk, subcutaneous semaglutide 0.5 or 1.0 mg weekly reduced CV death, non-fatal MI or non-fatal stroke versus placebo.

N
3,297
Design
Double-blind RCT, median 2.1 yr
Endpoint
3-point MACE
Relevance
2
Result6.6 % vs 8.9 %; HR 0.74 (p=0.02). Non-fatal stroke −39 %. Retinopathy complications increased (HR 1.76; p=0.02).
Marso SP, et al. N Engl J Med. 2016;375(19):1834-1844. 10.1056/NEJMoa1607141
Discussion & critique

Confirmed the GLP-1 RA class effect on MACE; the retinopathy signal remains debated and probably reflects rapid glycaemic improvement.