Jardiance (empagliflozin) is a medicine for heart failure approved by the FDA in 2014. Jardiance is also approved for adults and children with type 2 diabetes, adults with type 2 diabetes and heart disease, and adults with kidney disease. Jardiance is not approved for use in type 1 diabetes. This article will focus on Jardiance for people with heart failure with and without diabetes.
How Does Jardiance Work for Heart Failure?
Jardiance helps to lower the workload on the heart. Normally, the kidneys filter in a way that keeps all of the sugar in the bloodstream rather than allowing the sugar to leave the body through the urine. The kidney protein that is responsible for this process is called sodium-glucose cotransporter-2 (SGLT2). Jardiance works by temporarily stopping the SGLT2 proteins from working, therefore allowing more sugar (glucose) to leave the body through the urine. This causes an increase in the amount of urine that your body makes. The increase in urine causes diuresis (also known as water loss), weight loss, and a decrease in blood pressure, therefore decreasing the workload on the heart.
How Was Jardiance Studied for Heart Failure?
Two clinical studies were done to test if Jardiance was safe and effective for people with heart failure. Echocardiography (also known as an “echo”) is done to measure heart health in people with heart failure. An echo determines the ejection fraction of the heart, which is the percentage of blood in the heart that is pumped out with each heartbeat. The studies focused on people with two different types of heart failure:
- Reduced ejection fraction: An ejection fraction of 40% or less
- Preserved ejection fraction: An ejection fraction of greater than 40%
The studies measured the effect of Jardiance on people with heart failure, some of whom also had diabetes. People with a recent heart attack or heart surgery, recent stroke, very low blood pressure, high blood pressure, or severe kidney disease were not included in the study. Of the people in the study with reduced ejection fraction, about 76% were White, 14% Asian, and 4% Black. Of those with preserved ejection fraction, about 71% were White, 18% Asian, and 7% Black.
What Benefits Were Seen With Jardiance?
Results from the clinical studies are provided below, so you can have an idea of what result you may have with Jardiance. Your results may be different from what was seen in clinical studies.
Jardiance in adults with heart failure with reduced ejection fraction
The effects of Jardiance were studied in adults with heart failure who had an ejection fraction of 40% or less. Their average ejection fraction was 28%. The average age was 67, and 24% of the people studied identified as female. Roughly half of the people in the study also had type 2 diabetes, and about one-third had prediabetes. People in the study were also taking standard heart failure medicines. Compared to a placebo, Jardiance decreased heart-related death and heart failure-related hospitalizations. Having or not having diabetes did not change how well Jardiance worked.
Jardiance 10 mg daily | Placebo | |
| Percentage of people who had a heart-related death or heart failure-related hospitalization within 16 months | 19.4% | 24.7% |
This study also measured the effect of Jardiance on kidney health. Compared to a placebo, people with and without diabetes who were taking Jardiance showed a slower decrease in kidney function over time, meaning Jardiance helped to preserve higher kidney function. Compared to a placebo, Jardiance also lowered the risk of developing kidney issues (such as the need for dialysis, the need for a kidney transplant, or a large decrease in kidney function) by 47% in people with diabetes and by 58% in people without diabetes.
Jardiance in adults with heart failure with preserved ejection fraction
The effects of Jardiance were studied in adults with heart failure who had an ejection fraction of greater than 40%. The average age was 72, and 45% of the people studied identified as female. Roughly half of the people in the study also had type 2 diabetes, and about one-third had prediabetes. People in the study were also taking standard heart failure medicines. Compared to a placebo, Jardiance decreased heart-related death and heart failure-related hospitalizations.
Jardiance 10 mg daily | Placebo | |
| Percentage of people who had a heart-related death or heart failure-related hospitalization within 26 months | 13.8% | 17.1% |
This study also measured the effect of Jardiance on kidney health. Compared to a placebo, people with and without diabetes who were taking Jardiance showed a slower decrease in kidney function over time, meaning Jardiance helped to maintain higher kidney function. Compared to a placebo, Jardiance did not change the risk of developing kidney issues such as the need for dialysis, the need for a kidney transplant, or a large decrease in kidney function.
What Types of Medicine Interactions Can Happen?
In people with type 2 diabetes, taking Jardiance with other diabetes medicines such as insulin and sulfonylureas can cause low blood sugars. Your health care provider may decrease the doses of your other diabetes medicines when starting Jardiance to prevent low blood sugars.
Jardiance increases urine production. If you are already taking a medicine that causes an increase in urination, such as a diuretic (also known as a “water pill”) including furosemide or hydrochlorothiazide, adding Jardiance may cause dehydration. Work with your health care provider to adjust your fluid intake if necessary.
Jardiance can interact with and lower the blood levels of a mental health medicine called lithium. If you are taking lithium and start taking Jardiance, your health care provider may ask you to complete bloodwork to monitor your lithium levels more often.
How Do I Take Jardiance?
Jardiance is an oral tablet taken once daily. Your health care provider will either prescribe a daily dosage of a full tablet or a half-tablet. Read the instructions for use, which you can get from your pharmacist. Your health care provider may recommend taking Jardiance in the morning so that the increase in urination will mostly happen during the day and will be less likely to interrupt your sleep. Jardiance continues to work 3 to 14 days after stopping the medicine.
How Can I Tell if Jardiance Is Working?
You can tell if Jardiance is working because your heart failure symptoms, bloodwork, or heart imaging studies such as echocardiography may improve. You may notice weight loss and a decrease in blood pressure. If you take a urine glucose test while on Jardiance, it is normal to see higher levels of glucose in the urine.
How Can I Prevent Side Effects or Tell if a Side Effect Is Happening?
If taken with other blood sugar-lowering medicines, Jardiance can cause low blood sugar (hypoglycemia). This can be serious and may lead to death. If you have diabetes, you may need to check your blood sugar more often if you have changes in your diet, exercise routine, or medicines for diabetes. If you do not have diabetes, Jardiance does not raise your risk of having low blood sugar.
Jardiance also can cause water loss, which can lead to dehydration. Your health care provider may want to have you complete kidney labs to make sure that your kidneys are not impacted by dehydration. Work with your health care provider to adjust your fluid intake or medicines if necessary.
Jardiance can cause a dangerous condition called ketoacidosis. This is most likely to happen in people with type 1 diabetes, but it can also happen in people with type 2 diabetes and people who do not have diabetes. When your body is not able to use the sugar that you are taking in because you are not making or taking enough insulin, your body uses a process called ketosis to get energy. Ketosis results in a production of chemicals called ketones, which change the pH of your blood and can be dangerous and even deadly. This condition is more likely to happen if you are not eating the way you normally do or miss doses of certain diabetes medicines. Symptoms of ketoacidosis can include the following:
- Nausea, vomiting, or belly pain
- Tiredness
- Fruity-smelling breath
- Shortness of breath
Your health care provider may ask you to monitor your ketone levels at home (through a home urine test). Stop Jardiance and get medical help right away if you have symptoms of ketoacidosis.
Jardiance can cause infections, some of which may be serious. Because Jardiance pushes more sugar into the urine, and bacteria and certain fungi (yeast) thrive in a high-sugar environment, Jardiance can cause kidney, bladder, and genital fungal (yeast) infections, which can possibly lead to more serious infections. Make sure to stay hydrated and perform normal hygiene (such as normal daily showers) when taking Jardiance. Let your health care provider know right away if you have pain or discomfort during urination, pain or discomfort in the genital area, genital itching, or changes in discharge.
A serious infection of the genital or perineal area called necrotizing fasciitis of the perineum (Fournier’s gangrene) can happen and can lead to hospitalization, surgeries, and death. Let your health care provider know right away if you have fever or tiredness along with pain, redness, or swelling in the genital or perineal area.
An increase in toe, foot, and leg amputations were seen in people taking Jardiance, particularly in people who have a history of a vein condition called peripheral artery disease or have had previous diabetic foot problems or amputations. If you have diabetes, look over your feet daily, be careful when walking barefoot to avoid injury, and let your health care provider know right away if you have any sores, wounds, or suspect any infections.
Jardiance may cause allergic reactions, which can be serious. Stop using Jardiance and get medical attention right away if you develop swelling of the lips, face, tongue, or throat (angioedema) or hives. Jardiance may not be safe in pregnancy and is not safe to use while breastfeeding. Let your health care provider know right away if you become pregnant or if you are breastfeeding.
Reports of side effects are very important and are used to add information to the prescribing information. You don’t need to be certain that something you experienced was caused by Jardiance. If you experience anything that you think may be caused by Jardiance, you can report it by calling the FDA at 800-FDA-1088 (800-332-1088) or Boehringer Ingelheim Pharmaceuticals at 800-542-6257.
Is There a Coupon Card Available?
A Jardiance Savings Card from the drugmaker may allow you to pay as little as $10 for your Jardiance prescription. Whether you are eligible depends on the type of insurance plan you have and if your insurance covers Jardiance. You can find out more at https://patient.boehringer-ingelheim.com/us/products/jardiance/heart-failure/savings-support/savings.
