Novo Nordisk: cardiovascular outcomes study

(CercleFinance.com) - Novo Nordisk has announced the main results of the SOUL cardiovascular outcomes study.


This randomised, double-blind trial compared oral semaglutide to placebo as an adjunct to usual care for the prevention of major adverse cardiovascular events (MACE).

The trial involved 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

As part of standard care, 49% of patients received SGLT2i at some point during the trial.

The trial met its primary objective by demonstrating a statistically significant and superior reduction in MACE of 14% for those treated with oral semaglutide versus placebo.

The company is pleased that the results of the SOUL trial demonstrate that oral semaglutide reduces the risk of cardiovascular events, and that the benefits of oral semaglutide are additional to standard of care.

Novo Nordisk expects to file for regulatory approval for Rybelsus label extension in the US and EU towards the end of the year.


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