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FDA Approves Heart Protective Benefits of Trulicity

By Jimmy McDermott

Trulicity can now be prescribed to reduce the risk of stroke and heart attack in adults with type 2 diabetes and with heart disease or those who at risk for heart disease

Trulicity is the first diabetes drug to receive this heart health approval for people with and without existing heart disease. Trulicity was already approved to lower blood sugar in type 2 people with type 2 diabetes. The FDA approval of this “label update” means that Trulicity can now be formally prescribed to reduce the risk of cardiovascular events.

This approval was based on the results of the REWIND trial. REWIND showed that Trulicity resulted in a 12% reduced risk of combined non-fatal stroke, non-fatal heart attack, and heart-related death compared to placebo (a “nothing” pill). 2.4% of people taking Trulicity experienced these events, compared to 2.7% of people taking placebo. Importantly, Trulicity’s heart benefits were seen in both people with and without established heart disease. As such, REWIND offers the first evidence that GLP-1 agonists may prevent strokes and heart attacks in people without diagnosed heart disease.

Trulicity is now the third GLP-1 agonist to gain an FDA approval for reducing risk of major cardiovascular events. Earlier this year, Ozempic was approved to reduce the risk of stroke, heart attack, and other major adverse cardiovascular events  in adults with type 2 diabetes and heart disease. In 2017, Victoza received this same approval. Many diabetes experts now believe that the heart protective benefit of GLP-1 agonists is a “class effect,” meaning that all GLP-1 agonist drugs can help improve heart health.

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