The FINANCIAL -- Ozempic (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.
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.
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.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.
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.