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Type 2

Type 2 Diabetes Therapy Invokana Approved to Reduce Risk of Heart Attack, Stroke, and Heart-Related Death

By Emma Ryan and Peter Rentzepis

FDA updates Invokana label – the type 2 diabetes therapy now improves heart health in type 2’s with established heart disease in addition to glucose lowering

For people with type 2 diabetes and existing heart disease, Invokana has been officially approved by the FDA to reduce the risk of heart attack, stroke, and heart-related death. This comes in addition to Invokana’s already-approved “indication,” or use, for lowering glucose.

Invokana is a once-daily pill for people with type 2; the new heart indication will be beneficial for people with diabetes and their healthcare providers, who can now openly discuss Invokana’s heart benefits. It will also apply to combination medications Invokamet (canagliflozin/metformin) and Invokamet XR (canagliflozin/metformin extended-release). For those interested in asking their healthcare provider about how they can watch out for heart health, check out this discussion guide put together by the ADA and AHA.

Results from the CANVAS trial, which enrolled over 10,000 people with type 2 diabetes at high risk of heart problems, showed that use of Invokana led to:

  • A 14% lower risk of heart-related death, heart attack, and stroke;

  • A 33% lower risk of hospitalization due to heart failure;

  • A 40% lower risk of developing kidney problems, like kidney-related death or needing dialysis;

  • And a nearly doubled risk for needing a lower limb amputation, regardless of pre-existing risk factors for amputation. The “absolute” risk of an amputation was 2% in the control group vs. 4% in the Invokana group.

Said another way: For every 1,000 people with diabetes who are treated with Invokana over five years, the study results indicate that on average, there will be:

  • 23 fewer to experience a negative heart outcome;

  • 17 fewer to experience hospitalization for heart failure;

  • 16 fewer to experience one of the kidney problems measured;

  • And 15 more to experience a lower-limb amputation (including 10 toe or forefoot amputations and five above-the-ankle amputations).

In addition to Invokana, there are additional type 2 diabetes medications approved by the FDA for heart protection. Jardiance, another SGLT-2 inhibitor, is approved to reduce heart-related death but not heart attacks or strokes, and Victoza, a once-weekly injectable GLP-1 agonist, has been approved for the same heart-protective benefits as Invokana.