Boehringer Ingelheim and Lilly initiate first ever study to assess Jardiance in people hospitalized for acute heart failure who have been stabilized
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
RIDGEFIELD, Conn.?and?INDIANAPOLIS, Nov. 12,?2019 /PRNewswire/ -- Boehringer Ingelheim and?Eli Lilly and Company?(NYSE: LLY) today announced the initiation of EMPULSE, the sixth phase III study in the Jardiance? (empagliflozin) heart failure program. The study will assess whether in-hospital administration of Jardiance 10 mg daily improves heart failure outcomes when initiated in people hospitalized for any type of acute heart failure event once they have been stabilized. The study will include participants both with and without type 2 diabetes.
Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease. Outcomes for patients after they have been hospitalized for heart failure are poor, with a 15 percent mortality and 30 percent readmission rate within 60 to 90 days of discharge from the hospital. Initiating treatment in the hospital is one of the best predictors of long-term improved prognosis and patient treatment adherence. The EMPULSE study aims to understand whether Jardiance?has the potential to improve outcomes in this population.
"Acute decompensated heart failure is one of the fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short term mortality and rehospitalization. Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure," said?Adriaan Voors, Professor of Cardiology, University Medical Center Groningen,?Netherlands. "The beneficial effects of SGLT2 inhibitors, as seen in three large randomized trials in type 2 diabetes patients, are thought to be at least partly explained by the diuretic/natriuretic effects of SGLT2 inhibitors. The EMPULSE study will investigate whether Jardiance, due to its mode of action, can alleviate symptoms associated with heart failure and improve outcomes after discharge from the hospital."
The primary outcome of the study will be net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalizations, urgent heart failure visits and unplanned patient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire ? Clinical Summary Score (KCCQ-CSS), an instrument for measuring disease-specific quality of life in heart failure.
"We are particularly delighted to announce the addition of EMPULSE as the first-ever study to assess the effects of Jardiance?in people who have been hospitalized for acute heart failure," 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.?"The study aims to address an unmet need and is an important addition to our broad and comprehensive heart failure program."
EMPULSE is part of the empagliflozin heart failure program, which also consists of the EMPEROR-Reduced and EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION studies. These studies are investigating the effects of empagliflozin on heart failure-related outcomes and functional capacity in more than 9,500 adults with heart failure, including those with and without diabetes.
About EMPULSE?(NCT04157751)
The EMPULSE study is a multicenter, randomized, double-blind, 90-day superiority study to evaluate the effect on clinical benefit, safety and tolerability of once-daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalized for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilizEd (EMPULSE).
CONTACT:
Jennifer Forsyth
Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email:?jennifer.forsyth@boehringer-ingelheim.com
Phone: (203) 791-5889
Stephan Thalen
Global Business Communications
Lilly Diabetes and Lilly?USA
Email:?stephan.thalen@lilly.com
Phone: (317) 903-5640
- Primary endpoint: Net clinical benefit, a composite of all-cause mortality, number of heart failure events (including hospitalizations for heart failure, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event and change from baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) after 90 days of treatment
- Anticipated number of patients: approx. 500
- 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.?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).
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
- are eating less due to illness, surgery, or 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.
?View original content to download multimedia:http://www.prnewswire.com/news-releases/boehringer-ingelheim-and-lilly-initiate-first-ever-study-to-assess-jardiance-in-people-hospitalized-for-acute-heart-failure-who-have-been-stabilized-300956005.html
SOURCE?Eli Lilly and Company