Full results from EMPERIAL exercise ability trials presented
RIDGEFIELD, Conn. and INDIANAPOLIS,
"The EMPERIAL trials, which assessed exercise ability, are one piece of our clinical program evaluating the potential of Jardiance in treating heart failure, a condition affecting 60 million people worldwide," said
As previously reported, the EMPERIAL trials showed no significant difference in change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. In EMPERIAL-Reduced, the median six-minute walk test increased by 13.5 meters with Jardiance compared with 18.0 meters with placebo. In EMPERIAL-Preserved the increase was 10.0 meters with Jardiance versus 5.0 meters with placebo.
Exploratory analyses of EMPERIAL-Reduced suggest Jardiance was associated with improvements in quality of life. Researchers employed the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used patient-reported measure of quality of life for heart failure. Mean improvement in total symptom score (TSS) of the KCCQ from baseline to week 12 was 4.55 points higher for Jardiance compared with placebo. Additionally, a greater proportion of those taking Jardiance had improvements compared with placebo in KCCQ-TSS of at least 5 and at least 8 points – two pre-specified thresholds that were identified to measure clinically meaningful response to treatment. Similar exploratory analyses of EMPERIAL-Preserved did not indicate improvements with Jardiance versus placebo in these same measures for adults with heart failure with preserved ejection fraction.
The EMPERIAL trials included people with and without diabetes. The safety profile in those with diabetes was similar to the known safety profile of Jardiance for adults with type 2 diabetes. In those without diabetes, no new safety events were identified, and the frequency of hypoglycemic events with Jardiance in this population was similar to that of placebo. Overall, in both trials, there was no notable difference between Jardiance and placebo in the frequency of adverse events, including those leading to discontinuation of study medication, and no new safety concerns were identified.
Other heart failure guideline-recommended therapies have shown divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.
"Cardio-renal-metabolic conditions, a group of disorders affecting the heart, kidneys and endocrine systems, are becoming increasingly common," said
EMPERIAL consisted of two Phase III randomized, double-blind trials in adults with or without diabetes. The trials evaluated the effect of 12 weeks' treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* The primary endpoint was measured by the six-minute walk test, a common measure of exercise ability.
- EMPERIAL-Preserved [NCT03448406]: investigated Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
- Number of patients enrolled: 315
October 9, 2019
- EMPERIAL-Reduced [NCT03448419]: investigated Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
- Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
- Number of patients enrolled: 312
October 7, 2019
*Ejection fraction is a measurement expressed as a percentage of the amount of blood that leaves the heart each time it contracts, related to the total blood volume of the heart chambers. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.
HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.
Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.
The EMPOWER program reinforces the long-term commitment of Boehringer Ingelheim and
The development program encompasses:
- EMPEROR-Reduced, in adults with chronic heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization due to heart failure
- EMPEROR-Preserved, in adults with chronic heart failure with preserved ejection fraction to reduce the risk of cardiovascular death and hospitalization due to heart failure
- EMPULSE, in adults hospitalized for acute heart failure to improve clinical and patient reported outcomes
- EMPACT-MI, to improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction
- EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death
- EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to improve exercise ability and patient reported outcomes
- EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to improve exercise ability and patient reported outcomes
- EMPA-REG OUTCOME®, in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death
- EMPRISE, assessing comparative efficacy, safety, healthcare resource utilization and costs of care in routine clinical care in adult patients with diabetes
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body's demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues. It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.
The Jardiance heart failure program was initiated based on data from the EMPA-REG OUTCOME trial, which assessed the effect of Jardiance added to standard of care compared with placebo added to standard of care. EMPA-REG OUTCOME was the first SGLT2 inhibitor trial to show a relative risk reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This population was comprised of more than 45% of adults with a prior myocardial infarction.
About Cardio-Renal-Metabolic Conditions
Cardio-renal-metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.
Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. We remain committed to developing treatments with broad cardio-renal-metabolic effects, which may help improve outcomes for people with serious chronic conditions such as these.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATION
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
Do not take JARDIANCE if you have severe kidney problems or are on dialysis.
JARDIANCE can cause serious side effects, including:
- Dehydration. JARDIANCE can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up.
You may be at a higher risk of dehydration if you:
- have low blood pressure
- take medicines to lower your blood pressure, including water pills (diuretics)
- are on a low salt diet
- have kidney problems
- are 65 years of age or older
- Vaginal yeast infection. Women who take JARDIANCE may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
- Yeast infection of the penis. Men who take JARDIANCE may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your doctor right away if you get any of the following symptoms, and if possible, check for ketones in your urine:
- stomach-area (abdominal) pain
- trouble breathing
- Kidney problems. Sudden kidney injury has happened in people taking JARDIANCE. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.
- Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
- Low blood sugar (hypoglycemia): If you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include:
- fast heartbeat
- shaking or feeling jittery
- Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
- Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include:
- swelling of your face, lips, throat and other areas of your skin
- difficulty with swallowing or breathing
- raised, red areas on your skin (hives)
If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.
- Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
Before taking JARDIANCE, tell your doctor if you:
- have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE
- have liver problems
- have a history of urinary tract infections or problems with urination
- are going to have surgery. Your doctor may stop your JARDIANCE before you have surgery. Talk to your doctor if you are having surgery about when to stop taking JARDIANCE and when to start it again
- are eating less or there is a change in your diet
- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
- drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
- have any other medical conditions
- are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with JARDIANCE
- are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and Medication Guide.
Boehringer Ingelheim and
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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects
Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.
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