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Randomized controlled trial

SUSTAIN-6: semaglutide (Ozempic) and heart outcomes in diabetes

With subcutaneous semaglutide (0.5 or 1 mg once weekly) over a median of 2.1 years, a major cardiovascular event occurred in 6.6% of patients, compared with 8.9% on placebo (hazard ratio 0.74; 95% CI, 0.58 to 0.95; p < 0.001 for noninferiority).

Marso SP et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. New England Journal of Medicine, 2016. DOI: 10.1056/NEJMoa1607141

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Key facts

Drug
semaglutide
Design
Randomized controlled trial
Participants
3,297
Duration
104 weeks
Funding
Novo Nordisk
Registry
NCT01720446
Population
3,297 adults with type 2 diabetes and high cardiovascular risk; 83% had established cardiovascular disease, chronic kidney disease or both.
Primary outcome
First major cardiovascular event (cardiovascular death, nonfatal heart attack or nonfatal stroke), with a primary noninferiority hypothesis versus placebo.

What it found

With subcutaneous semaglutide (0.5 or 1 mg once weekly) over a median of 2.1 years, a major cardiovascular event occurred in 6.6% of patients, compared with 8.9% on placebo (hazard ratio 0.74; 95% CI, 0.58 to 0.95; p < 0.001 for noninferiority). Nonfatal stroke was less frequent (1.6% versus 2.7%; HR 0.61; 95% CI, 0.38 to 0.99), while cardiovascular death was similar in both groups. Diabetic retinopathy complications were more frequent with semaglutide (HR 1.76; 95% CI, 1.11 to 2.78). More patients stopped treatment because of adverse effects, mainly digestive ones.

Limitations

Funded by Novo Nordisk. Designed to show noninferiority, not superiority; the number of events was relatively small. The retinopathy signal prompted later studies (FOCUS). It studied the diabetes doses, not the 2.4 mg dose.

What it means for you

In people with type 2 diabetes and high cardiovascular risk, semaglutide at the Ozempic doses did not increase cardiovascular events and was associated with fewer events than placebo. There were also more diabetic retinopathy complications. If you have diabetes, your doctor can explain whether any of this applies to you.

Further reading

Related trials

  • semaglutideEvent-driven

    SOUL

    Over a mean follow-up of 47.5 months, a major cardiovascular event occurred in 12.0% of participants on oral semaglutide and 13.8% on placebo.

  • semaglutideEvent-driven

    SELECT

    With a mean follow-up of 39.8 months, a major cardiovascular event occurred in 6.5% of patients on semaglutide 2.4 mg once weekly and in 8.0% on placebo.

  • semaglutide104 weeks

    evoke and evoke+

    At 104 weeks, CDR-SB worsened by 2.3 and 2.2 points on semaglutide in evoke and evoke+ and by 2.3 and 2.1 on placebo, with no significant differences.

  • semaglutide72 weeks

    ESSENCE

    At 72 weeks, steatohepatitis resolved without worsening of fibrosis in 62.9% on semaglutide and 34.3% on placebo, and fibrosis was reduced without worsening of steatohepatitis in 36.8% versus 22.4%.

Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. New England Journal of Medicine.Marso SP, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834-1844.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 27633186 (abstract).accessed .