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Semaglutide shows cardiovascular benefits in type 2 diabetes

Semaglutide shows cardiovascular benefits in type 2 diabetes

Publication date: Thursday, 27 October 2016
Contributor(s): Jeremy Bray

Results from the SUSTAIN 6 study show that semaglutide, an investigational human glucagon-like peptide-1 (GLP-1) analogue, significantly reduced the risk of the primary composite endpoint of time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction or non-fatal stroke by 26% vs placebo, when added to standard of care in adults with type 2 diabetes at high CV risk.
Semaglutide is a once-weekly GLP-1 analogue that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, while decreasing appetite and food intake. This study randomised 3297 patients with type 2 diabetes to treatment with semaglutide or placebo.

The main results from the SUSTAIN 6 study were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016 and published in the New England Journal of Medicine. The study showed a significant 39% decrease in non-fatal stroke and a non-significant 26% decrease in non-fatal myocardial infarction and a neutral outcome (2% decrease) in CV death after two years of treatment.

Lead author Dr Steven Marso said, “The reduction in cardiovascular events observed with semaglutide in SUSTAIN 6 is notable given the small study population and the short trial duration”. He added,   “These findings are clinically relevant, as cardiovascular disease is the leading cause of death in people with type 2 diabetes and new treatment options that can also reduce the risk of cardiovascular events are needed.”

When added to standard of care, semaglutide lowered the overall baseline HbA1c  of 8.7% over 104 weeks’ treatment (see table). In addition, from a mean baseline of 92.1 kg, adults treated with semaglutide 0.5 mg and 1.0 mg experienced superior and sustained weight loss of -3.6 kg and -4.9 kg, vs -0.7 kg for placebo 0.5 mg and -0.5 kg for placebo 1.0 mg.

Treatment

Reduction in HbA1c

Semaglutide 0.5 mg

-1.1%

Semaglutide 1.0 mg

-1.4%

Placebo

-0.4% 

Table: Reduction in HbA1c  after 104 weeks treatment.

ACTION
Cardiovascular effects of semaglutide are significantly lower than with placebo, and the SUSTAIN 6 study results suggest a role for the drug in the treatment of type 2 diabetes. Regulatory submission will begin in the near future and semaglutide may be available to prescribers in due course following further studies to prove benefits and clarify side-effects.

Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016, published online 15 September.  www.nejm.org/doi/full/10.1056/NEJMoa1607141

Topics covered:
Category: Evidence in Practice
Edition: Volume 1 Number 10 PCCJ Online 2016
Contributor(s): Jeremy Bray

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