Jardiance Becomes First Modern-Era Diabetes Drug to Improve Heart Health

By Kelly Close, Alexander Wolf, and Emily Regier

Twitter Summary: Jardiance becomes 1st-ever #type2 #diabetes drug to reduce risk for heart attack + stroke

Today, Lilly/BI announced first-ever news in diabetes: a major clinical trial on Jardiance, an SGLT-2 inhibitor pill for type 2 diabetes, has been proven to improve heart safety in patients at high risk for heart problems. In other words, taking Jardiance has been shown to reduce the risk of serious and often fatal heart complications, like heart attacks and strokes. This is big news for patients, as no other diabetes drug has ever shown to actually improve heart health (all others have so far only shown to be neutral in regards to heart health). The full data from this trial won’t be known until this year’s EASD Conference next month, so it’s unclear to what extent Jardiance actually reduces heart risk (i.e., does it lower heart disease risk by 5%? 10%? 25%?). While it’s likely that Jardiance has a relatively smaller effect on heart disease compared to drugs that directly target heart health (e.g., statins), even a minor reduction could be really meaningful and potentially prevent many cases of heart attacks and strokes, given the millions of people with diabetes at risk for heart disease.

The clinical trial observed over 7,000 adults with type 2 diabetes at high risk for cardiovascular (heart) problems taking Jardiance in addition to the "standard of care" for heart disease risk reduction (e.g., statins, blood pressure lowering drugs, aspirin, etc.) and diabetes care (most participants were taking other diabetes medications as well). This study – referred to as a “cardiovascular outcomes trial,” or CVOT (learn more here) – was designed specifically to study patients on Jardiance over a long period of time to understand its impact on heart safety. These heart studies became a mandatory part of the FDA drug approval process back in 2008. Following concerns that Avandia increased the risk of heart attacks (that were subsequently overturned), the FDA decided that all diabetes drugs should prove they are heart safe.

So what could this all mean?

1. "These results could potentially change the standard of care for type 2 diabetes," says Kelly Close. "While there are many drugs used to treat type 2 diabetes (sulfonylureas, DPP-4 inhibitors, SGLT-2 inhibitors, TZDs, GLP-1 agonists, etc.), these results may make Jardiance or other SGLT-2 inhibitors the standard second-line therapy (after metformin) used to treat type 2 diabetes (or potentially first-line therapy if the magnitude is really meaningful – we won’t know anything about that for a month, when the specifics on the results are disclosed). Much more information would be needed before this happens, but we think the question is an important one to raise."

2. While it’s possible that other SGLT-2 inhibitor drugs (Invokana and Farxiga) may also show similar results in their own CVOTs in the future, this trial can only validate that Jardiance specifically is heart healthy.

3. This news could mean major health improvements for patients – heart disease is the largest complication of diabetes, with as high as 65% of people with diabetes dying from heart disease or stroke.

4. Not only does this news mean Jardiance could potentially prevent heart attacks and strokes, but it could also significantly reduce healthcare costs spent on the treatment of heart disease. 

As Dr. John Buse succinctly summed it up, “This is great news for people with diabetes; I cannot wait to see the full results.” Us too!