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New results about Novo Nordisk’s Ozempic

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Ozempic consistently reduced the risk of the composite outcome of time to first occurrence of non-fatal heart attack, non-fatal stroke or cardiovascular death (i.e. 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.

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, organized by the European Society of Cardiology, in Munich, Germany.

“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 in people with type 2 diabetes, with varying profiles of cardiovascular risk at baseline.”

SUSTAIN 6

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 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. 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.

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. 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.