Jardiance? meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes
Jardiance (empagliflozin) significantly reduced the risk of cardiovascular death or hospitalization for heart failure versus placebo in the EMPEROR-Reduced heart failure trial. The study evaluated adults with heart failure with reduced ejection fraction
- Treatment of heart failure is an important unmet need with over half of those diagnosed dying within five years
RIDGEFIELD,?Conn.?and?INDIANAPOLIS,?July 30, 2020?/PRNewswire/ --?Positive top-line results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were announced today by?Boehringer Ingelheim?and?Eli Lilly and Company?(NYSE: LLY). EMPEROR-Reduced met its primary endpoint, demonstrating superiority with Jardiance??(empagliflozin) 10 mg compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care. Overall the safety profile was similar to the known safety profile of Jardiance.
"Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide," said?Milton Packer, M.D., Chair of the?Executive Committee for the EMPEROR Program?and Distinguished Scholar in Cardiovascular Science at?Baylor University Medical Center?in?Dallas. "The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments."
Heart failure is the leading cause of hospitalization in the?U.S., and the risk of death in people with heart failure rises with each hospital admission. Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart. Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.
"With these positive top-line results from the EMPEROR-Reduced trial, we are excited to mark another important advancement for Jardiance," said?Mohamed Eid, M.D., M.P.H, M.H.A, vice president,?Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine,?Boehringer Ingelheim Pharmaceuticals, Inc.?"There is an urgent need for new heart failure treatments, and these results show promise for the potential role Jardiance can play in improving the lives of adults living with this condition."
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the?European Society of Cardiology (ESC) Congress?2020 on?August 29, and regulatory submissions are planned in 2020. A second trial, EMPEROR-Preserved, is exploring the effect of Jardiance on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction ? an area with no approved treatment options. EMPEROR-Preserved results are expected in 2021.
The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of Jardiance on the lives of people across the spectrum of cardio-renal-metabolic conditions.
"These results build upon the already established cardiovascular benefits of Jardiance in adults living with type 2 diabetes and cardiovascular disease," said?Jeff Emmick, M.D., Ph.D., vice president, Product Development,?Lilly. "Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how Jardiance can help adults around the world living with these conditions."
About the EMPEROR Heart Failure Studies
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two phase III, randomized, double-blind trials investigating once-daily Jardiance compared with placebo in adults with heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
- EMPEROR-Reduced?[NCT03057977] investigated the safety and efficacy of Jardiance in patients with heart failure with?reduced ejection fraction?(HFrEF).
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 3,730
- Completion: 2020
- EMPEROR-Preserved?[NCT03057951] investigates the safety and efficacy of Jardiance in patients with heart failure with?preserved ejection fraction?(HFpEF).
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
- 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:
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- 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:
- nausea
- vomiting
- stomach-area (abdominal) pain
- tiredness
- 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:
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- 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).
- 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