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FDA Approves Heart Protective Benefits of Ozempic and Confirms Safety of Rybelsus

By Jimmy McDermott and Eliza Skoler

Ozempic, a once weekly injectable GLP-1 agonist drug, is now approved to reduce the risk of heart attack and stroke. Rybelsus (a pill version of Ozempic) is confirmed to be safe for the heart

The FDA approved Ozempic, a once weekly injectable GLP-1 agonist medication, in December 2017 to be taken by people with type 2 diabetes. Just last week, the FDA approved what’s called a “label update” – now, Ozempic is approved not just to improve diabetes management but is also formally approved to reduce the risk of stroke, heart attack, and other major adverse cardiovascular events (MACE) in adults with type 2 diabetes and heart disease. This is a big deal – it’s a big reduction!

This approval was based on results from the SUSTAIN 6 and PIONEER 6 trials. The combined data from these trial show that Ozempic, compared to placebo (a nothing pill), reduced the risk of heart attack, stroke, and heart-related death by a whopping 24%. While there was no meaningful difference in the number of heart attacks or heart-related deaths, there was a significant 35% reduction in stroke. In the combined results, 169 people had a negative heart-related event when taking Ozempic, versus 222 people when taking a placebo. There were about 3,240 participants in each group.

Ozempic is the second GLP-1 agonist medication to be approved to reduce the risk of negative heart-related events (after Victoza). Trulicity may see the same heart health approval in the coming months – the REWIND results from FDA’s opinion on cardiovascular risk will be particularly important since REWIND had many people in the trial who did not already have cardiovascular disease. With that in mind, the REWIND results will be seen to be more “generalizable.”

The kidney health benefits of Ozempic are currently being studied in the FLOW trial, which is expected to complete in 2024. This is the first study of GLP-1 agonists and kidney health.

The FDA also added data to the label for Rybelsus (a pill version of Ozempic), confirming that it is safe for the heart. This decision was based on results from the PIONEER 6 trial. In a population of people with type 2 diabetes and heart disease or risk factors for heart disease, compared to placebo, Rybelsus reduced the risk of heart-related death by 51% but did not have a meaningful difference on the risk of heart attack or stroke.

This past September, Rybelsus was approved, bringing much excitement to the diabetes community. While the trial data do not yet prove the heart protection benefits of Rybelsus, we expect that Rybelsus will eventually have a similar “cardioprotection” label over time. An ongoing trial – SOUL – is investigating the heart health effects of Rybelsus. The manufacturer is seeking risk reduction indication for the pill as a result of this trial. Based on the fact that Rybelsus is the same as Ozempic in pill form, many doctors and researchers expect that to be positive as well in reducing the risk of negative heart events (mainly stroke).

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