Jardiance: The First Diabetes Drug to Reduce Risk of Heart-Related Death

By Ava Runge

The FDA officially approves the new, expanded indication for people with type 2 diabetes

Six months after a close FDA advisory panel vote, the FDA has officially approved a new indication for Jardiance (empagliflozin) for the reduction of heart-related deaths in people with type 2 diabetes and established heart disease. Jardiance, an SGLT-2 inhibitor once-daily pill made by Lilly/BI, is currently used to improve glucose control by causing the kidneys to urinate out excess glucose.

This FDA decision allows Jardiance’s label to be updated to reflect results from a major heart safety clinical trial (EMPA-REG OUTCOME) that showed reduction in death from heart disease in people taking Jardiance. The label update makes Jardiance the first-ever diabetes medication to be approved for reducing heart-related death. As diaTribe contributors Helen Gao and Emily Regier remarked in speeches bringing the patient perspective to the FDA Advisory Committee, the label update will also help spread awareness to healthcare providers and their patients about both heart-related complications associated with diabetes and the groundbreaking EMPA-REG OUTCOME findings.

What did the EMPA-REG OUTCOME trial find?

The EMPA-REG OUTCOME trial observed over 7,020 adults with: type 2 diabetes; an established history of heart disease; standard treatment 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); plus, treatment with Jardiance. Results from EMPA-REG OUTCOME, first announced in September 2015, showed that compared to placebo, Jardiance led to the following over a nearly-four-year period:

• a 14% reduction in total “cardiovascular events” (heart attacks, strokes, heart-related deaths)

• a 38% reduction in risk of heart-related death

• a 32% reduction in overall death

• a 35% reduction in hospitalizations from heart failure

In addition to the very meaningful 32% reduction in overall death in trial participants on Jardiance, new data from the trial just released in June 2016 showed – surprisingly – that Jardiance also lowered the risk of kidney disease by 39% in people with type 2 diabetes and an established history of heart disease – a big deal! The trial did also reveal a slightly higher rate of strokes in people treated with Jardiance, though this was “non-statistically significant,” meaning it may have been due to chance.

These results are very relevant for those with type 2 diabetes and established heart disease, though they cannot necessarily be applied to all people with type 2 diabetes (e.g., those just diagnosed). For more details, see past diaTribe coverage from Lilly/BI’s initial announcement about the groundbreaking EMPA-REG trial and its results.