Ozempic(R) Consistently Reduced the Risk of Major Cardiovascular Events Across Type 2 Diabetes Populations at High CV Risk Regardless of Prior CV Events at Baseline

PR74893

MUNICH, Aug. 26, 2018 /PRNewswire=KYODO JBN/--

Ozempic(R) Consistently Reduced the Risk of Major Cardiovascular Events Across

Type 2 Diabetes Populations at High CV Risk Regardless of Prior CV Events at

Baseline

Ozempic(R) (semaglutide) consistently reduced the risk of the composite outcome

of time to first occurrence of non-fatal heart attack, non-fatal stroke or

cardiovascular death (collectively termed major adverse cardiovascular events,

MACE) in people with type 2 diabetes at high cardiovascular risk regardless of

previously having had a cardiovascular event at the start of the trial.1

Findings from two post-hoc subgroup analyses of the SUSTAIN 6 trial and one

post-hoc meta-analysis of MACE in the SUSTAIN 1-5 trials were presented today

at the ESC Congress 2018, organised by the European Society of Cardiology, in

Munich, Germany.1

"Cardiovascular disease remains the leading cause of disability and death in

people with type 2 diabetes and there is an increasing focus on reducing

cardiovascular risk in the clinic," said Professor Stephen Bain, School of

Medicine, Swansea University, UK. "We have seen from clinical trials that

diabetes treatments confer variable effects on cardiovascular outcomes and the

results of these post-hoc analyses provide further evidence of the consistent

cardiovascular risk reduction of Ozempic(R) in people with type 2 diabetes,

with varying profiles of cardiovascular risk at baseline."

The SUSTAIN 6 post-hoc analyses found that reduction in the risk of MACE was

consistent in people at high cardiovascular risk treated with Ozempic(R)

regardless of their cardiovascular risk profile at the start of the trial,

including whether or not they had a prior heart attack or stroke, and whether

they had cardiovascular risk factors or established cardiovascular disease.1

SUSTAIN 6 was a pre-approval cardiovascular outcomes trial in 3,297 people with

type 2 diabetes and established cardiovascular disease or with at least one

cardiovascular risk factor, compared to placebo, both in addition to standard

of care.2

The post-hoc pooled meta-analysis of the SUSTAIN 1-5 efficacy trials, which

included 4,807 people, trended towards a lower risk of MACE in people taking

Ozempic(R). The comparators included in SUSTAIN 1-5 were placebo, sitagliptin,

exenatide extended release and insulin glargine U100. The overall incidence of

MACE was low across the SUSTAIN 1-5 trials and, due to the low number of

events, this reduction did not achieve statistical significance.1

About Ozempic(R)

Ozempic(R)(semaglutide) is a once-weekly analogue of human glucagon-like

peptide-1 (GLP-1) indicated for the treatment of adults with insufficiently

controlled type 2 diabetes as an adjunct to diet and exercise to improve

glycaemic control in adults with type 2 diabetes, as monotherapy when metformin

is considered inappropriate due to intolerance or contraindications, or in

addition to other medicinal products for the treatment of diabetes.3 Ozempic(R)

was approved by the U.S. Food and Drug Administration on 5 December, 2017, by

Health Canada on 4 January, 2018, by the European Commission on 9 February,

2018 and on 23 March, 2018 by the Japanese Ministry of Health, Labour and

Welfare.4-7

About the SUSTAIN clinical trial programme

The SUSTAIN global clinical development programme for Ozempic(R)comprises eight

phase 3a trials, encompassing more than 8,000 adults with type 2 diabetes. The

phase 3a programme involves a broad range of people with type 2 diabetes,

including some with high cardiovascular risk profiles.  

The primary analysis of the SUSTAIN 6 trial was published in The New England

Journal of Medicine.2 The primary outcome measure was a composite outcome of

major adverse cardiovascular events (MACE), defined as non-fatal myocardial

infarction, non-fatal stroke or cardiovascular death. Ozempic(R)-treated

patients had a significant 26% lower risk of MACE vs those receiving placebo

over 2 years (hazard ratio 0.74; 95% confidence interval 0.58-0.95).2 SUSTAIN 6

was designed to assess non-inferiority, i.e. demonstrate no increased risk of

major cardiovascular events vs placebo, when added to standard of care. Testing

for superiority was not part of the pre-specified analysis.

About Novo Nordisk:

Novo Nordisk is a global healthcare company with 95 years of innovation and

leadership in diabetes care. This heritage has given us experience and

capabilities that also enable us to help people defeat obesity, haemophilia,

growth disorders and other serious chronic diseases. Headquartered in Denmark,

Novo Nordisk employs approximately 43,100 people in 79 countries and markets

its products in more than 170 countries. For more information, visit

novonordisk.com

Facebook: https://www.facebook.com/novonordisk

Twitter: https://twitter.com/novonordisk

LinkedIn: https://www.linkedin.com/company/novo-nordisk

YouTube: https://www.youtube.com/user/novonordisk/custom

References

Bain S, Réa R, Warren ML, et al. Semaglutide consistently reduces

cardiovascular risk in patients with type 2 diabetes regardless of baseline

cardiovascular risk level: post hoc analyses of the SUSTAIN trial programme.

Abstract number P-2859. Presented at the 2018 Congress of the European Society

of Cardiology, Munich, Germany. 25-29 August.

Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in

patients with type 2 diabetes. N Engl J Med. 2016;375:1834-1844.

EMA. Ozempic(R) (semaglutide) SmPC. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004174/WC500244163.pdf.

Last accessed: July 2018.

Novo Nordisk. Ozempic(R) approved in the EU for the treatment of type 2

diabetes. Available at: https://www.novonordisk.com/bin/getPDF.2167679.pdf.

Last accessed: August 2018.

Novo Nordisk. Ozempic(R)(semaglutide) approved in the US. Available at:

https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2154210.html.

Last accessed: August 2018.

Novo Nordisk. Ozempic(R) approved in Canada for the treatment of adults with

type 2 diabetes. Available at:

http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Ozempic%20press%20release_Eng_01.08.2018_FINAL.pdf

Last accessed: August 2018.

Novo Nordisk. Ozempic(R) approved in Japan for the treatment of type 2

diabetes. Available at:

https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.html.

Last accessed: August 2018.

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com;

Asa Josefsson

+45 3079-7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com;

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com;

Valdemar Borum Svarrer

+45-3079-0301

jvls@novonordisk.com

Source: Novo Nordisk