FDA Approves Type 2 Diabetes Drug Jardiance for Heart Failure
Key takeaways:
In August 2021, Jardiance (empagliflozin) was FDA-approved to treat heart failure with reduced ejection fraction (HFrEF) in people with or without diabetes.
Jardiance is a once-daily oral tablet. Common side effects include genital yeast infections and urinary tract infections (UTIs).
There are many ways to save on Jardiance. If you’re eligible, a manufacturer savings card can help you access Jardiance for as little as $10 per month. A patient assistance program is also available.
Table of contents
In August 2021, the pharmaceutical manufacturer Boehringer Ingelheim announced the FDA approval of a new use for Jardiance (empagliflozin). This type 2 diabetes medication is now also approved to treat a type of heart failure — heart failure with reduced ejection fraction (HFrEF).
Jardiance is now the second medication in its class to be FDA-approved for both type 2 diabetes and heart failure — the other being Farxiga (dapagliflozin). However, people can take these medications to treat heart failure even if they don’t have diabetes. This gives healthcare providers more options for treating heart failure — a heart condition that affects over 6 million adults in the United States.
Here, we’ll discuss what Jardiance is, the type of heart failure it’s FDA-approved to treat, and what to expect if your healthcare provider prescribes it for you.
What is Jardiance?
Jardiance is a once-daily oral tablet known as a sodium-glucose co-transporter-2 (SGLT2) inhibitor. It works by removing extra blood sugar (glucose) from your body through the kidneys. Other medications in this class include Farxiga, Invokana (canagliflozin), and Steglatro (ertugliflozin).
What was Jardiance previously approved for?
Jardicane has two previous FDA approvals. In 2014, this medication was initially approved to treat type 2 diabetes along with proper diet and exercise. Based on results from a 2015 clinical trial, the FDA also approved Jardiance in 2016 to lower the risk of heart-related death in adults with type 2 diabetes — one of the potential complications of this condition.
What is heart failure?
Heart failure is a condition where the heart cannot efficiently pump blood out of the heart. This can cause extra fluid to build up throughout your body. People with heart failure often experience swelling in the feet and legs, shortness of breath, and tiredness. However, this condition can cause fluid to back up into your lungs in more severe cases — sometimes referred to as congestive heart failure.
Heart failure is common, with 1 in 5 adults over age 40 estimated to develop it during their lifetime. There are multiple risk factors for this condition, including a history of heart attacks, high blood pressure, and lung problems like COPD. While there are a few forms of heart failure, the two most common are HFrEF and heart failure with preserved ejection fraction (HFpEF). HFrEF is sometimes called systolic failure, and HFpEF is sometimes called diastolic failure.
What is reduced ejection fraction?
Ejection fraction (EF) is a measurement that tells your healthcare provider how efficiently your heart is pumping blood to the rest of your body. Typically, your EF is represented by a percentage. Your EF is considered normal if it’s at or above 50%.
HFrEF is when your EF is at or below 40%. This means that your heart has pumped out no more than 40% of the oxygen-rich blood to your body. The other 60% or more is still inside your heart. This can leave you feeling tired because your body isn’t receiving the oxygen it needs.
How does Jardiance treat heart failure?
A clinical trial compared Jardiance to placebo — a pill with no medication in it — in over 3,700 people with HFrEF for roughly 16 months. At the end of the study, participants who took Jardiance experienced fewer hospital stays related to heart failure and had a lower risk of death due to heart failure than those taking the placebo. These results were similar to those seen with Farxiga in its heart failure study.
At this time, experts are unsure exactly how Jardiance and other SGLT2 inhibitors treat heart failure. So far, it’s believed that these medications remove extra fluid from the bloodstream through the kidneys and help take stress off the heart. However, it’s thought that Jardiance’s benefits may also be due to its abilities to lower blood pressure, lower heart inflammation, and prevent the heart from changing shape over time.
Researchers are continuing to investigate SGLT2 inhibitors, as it seems their benefits may extend beyond diabetes and heart failure.
Does Jardiance only treat heart failure in people with type 2 diabetes?
No. During the clinical trial that earned Jardiance its HFrEF approval, about half of the participants had type 2 diabetes, and half did not. People experienced similar results with Jardiance regardless of whether they had diabetes. This is why the FDA approved Jardiance for HFrEF in adults with or without diabetes.
What are the side effects of Jardiance for heart failure?
Side effects of Jardiance, when taken for heart failure, are similar to those seen when people take the medication for type 2 diabetes. A common side effect of this medication is genital yeast infections, which can happen to people of all genders. However, it is more common for people with female genitalia.
Other common side effects of Jardiance include:
Urinary tract infections (UTIs)
Upper respiratory infections (e.g., runny nose, sneezing)
Having to urinate more often than usual
It’s possible to experience dehydration while taking Jardiance. Your risk of this side effect goes up if you are also taking certain diuretics (“water pills”), like furosemide (Lasix). Your healthcare provider may ask you to have regular blood tests done while taking Jardiance to watch for signs of dehydration.
How to save on Jardiance
There are ways to save on Jardiance, which is only available as a brand-name medication. GoodRx can help you navigate between patient assistance programs and copay savings cards to save money on your prescription.
Save with patient assistance programs. If you’re uninsured or underinsured, you may be eligible for Jardiance’s patient assistance program, which offers the medication free of cost.
Save with a copay savings card. If you have commercial insurance, you may be eligible to pay as little as $10 for Jardiance using a savings card from the manufacturer.
The bottom line
In August 2021, the FDA approved Jardiance to treat HFrEF in people with or without diabetes. This medication has been shown to lower the risk of complications and death due to this type of heart failure. Jardiance is generally well-tolerated, but it can lead to dehydration — especially if you take water pills. If you have HFrEF, be sure to discuss Jardiance with your healthcare provider at your next appointment.
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References
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American Heart Association. (2017). Types of heart failure.
Boehringer Ingelheim. (n.d.). Boehringer Ingelheim Cares Foundation.
Boehringer Ingelheim. (2021). U.S. FDA approves Jardiance® (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
Boehringer Ingelheim Pharmaceuticals, Inc. (2022). Jardiance [package insert].
Bozkurt, B., et al. (2021). 2021 ACC/AHA key data elements and definitions for heart failure: A report of the American College of Cardiology/American Heart Association task force on clinical data standards (writing committee to develop clinical data standards for heart failure). Circulation: Cardiovascular Quality and Outcomes.
Centers for Disease Control and Prevention. (2020). Heart failure.
Clegg, L. E., et al. (2019). Reduction of cardiovascular risk and improved estimated glomerular filtration rate by SGLT2 inhibitors, including dapagliflozin, is consistent across the class: An analysis of the placebo arm of EXSCEL. Diabetes Care.
Eli Lilly and Company. (2014). FDA approves Jardiance® (empagliflozin) tablets for adults with type 2 diabetes.
Eli Lilly and Company. (2016). U.S. FDA approves Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
Lopaschuk, G. D., et al. (2020). Mechanisms of cardiovascular benefits of sodium glucose co-transporter 2 (SGLT2) inhibitors: A state-of-the-art review. JACC: Basic to Translational Science.
McMurray, J. J. V., et al. (2019). Dapagliflozin in patients with heart failure and reduced ejection fraction. The New England Journal of Medicine.
Packer, M., et al. (2020). Cardiovascular and renal outcomes with empagliflozin in heart failure. The New England Journal of Medicine.
Zinman, B., et al. (2015). Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. The New England Journal of Medicine.
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