Full results from EMPERIAL exercise ability trials presented
Full results from EMPERIAL exercise ability trials presented
Full results from EMPERIAL exercise ability trials presented
EMPERIAL運動的全部結果能力提交的試驗
Full results from EMPERIAL exercise ability trials presented
EMPERIAL運動能力試驗的完整結果公佈
PR Newswire
美通社
RIDGEFIELD, Conn. and INDIANAPOLIS, June 19, 2020
康涅狄格州里奇菲爾德印第安納波利斯，2020年6月19日
RIDGEFIELD, Conn. and INDIANAPOLIS, June 19, 2020 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to exercise ability and symptom improvement with Jardiance®(empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. The results were presented through the European Society of Cardiology's HFA Discoveries program.
康涅狄格州里奇菲爾德和印第安納波利斯，2020年6月19日/美通社/--勃林格-英格爾海姆和禮來公司(紐約證券交易所：伊利)今天宣佈了EMPERIAL減少和EMPERIAL保留試驗的全部結果，這些試驗分別與使用佳迪®(依帕利福秦)治療射血分數減少和保留的慢性心力衰竭成人患者的運動能力和症狀改善有關。這一結果通過歐洲心臟病學會的HFA發現計劃公佈。
"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 Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "At the center of our heart failure program are the ongoing EMPEROR trials, which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life. We look forward to sharing results from the EMPEROR-Reduced trial this year for people with heart failure and reduced ejection fraction."
“評估運動能力的EMPERIAL試驗是我們臨牀計劃的一部分，用於評估Jardiance治療心力衰竭的潛力。心力衰竭影響着全球6000萬人，”醫學博士、M.P.H.、M.H.A.副主任總裁説，他負責臨牀開發和醫療事務、心臟代謝和呼吸醫學、勃林格-英格爾海姆製藥公司。我們心力衰竭計劃的核心是正在進行的IMPOSE試驗，該試驗正在調查包括心血管死亡、心力衰竭住院和生活質量在內的結果。我們期待着分享今年針對心力衰竭和射血分數降低的人的IMPOWER縮減試驗的結果。
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.
正如之前報道的那樣，EMPERIAL試驗顯示，從基線到第12周，服用Jardiance和服用安慰劑的運動能力沒有顯著差異，這是研究的主要終點-6分鐘步行測試。在EMPERIAL-Reduced試驗中，服用Jardiance的6分鐘步行試驗的中位數增加了13.5米，而服用安慰劑的則增加了18.0米。在EMPERIAL保留組中，服用Jardiance的患者增加了10.0米，而服用安慰劑的患者增加了5.0米。
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.
對EMPERIAL-Reduced的探索性分析表明，賈迪斯與生活質量的改善有關。研究人員使用了堪薩斯城心肌病問卷(KCCQ)，這是一種廣泛使用的患者報告的心力衰竭生活質量衡量標準。從基線到第12周，KCCQ的總症狀評分(TSS)的平均改善Jardiance組比安慰劑組高4.55分。此外，服用Jardiance的患者中，與安慰劑相比，KCCQ-TSS中有更大比例的改善至少5分和至少8分-這兩個預先指定的閾值被確定為衡量對治療有臨牀意義的反應。對EMPERIAL-REVED的類似探索性分析沒有表明，在相同的測量方法中，對於射血分數保留的心力衰竭患者，Jardiance與安慰劑相比有改善。
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.
EMPERIAL試驗包括糖尿病患者和非糖尿病患者。糖尿病患者的安全性與已知的Jardiance對成人2型糖尿病的安全性相似。在那些沒有糖尿病的人中，沒有發現新的安全事件，在這一人羣中，使用Jardiance的低血糖事件的頻率與安慰劑相似。總體而言，在兩項試驗中，Jardiance和安慰劑在不良事件(包括那些導致停止研究用藥的事件)的頻率方面沒有顯著差異，也沒有發現新的安全問題。
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.
其他心力衰竭指南推薦的治療方法在檢查臨牀結果和症狀改善的研究中顯示出不同的結果，其中一些顯示出死亡率等結果的改善，但運動能力和患者報告的結果中性或不一致。
"Cardio-renal-metabolic conditions, a group of disorders affecting the heart, kidneys and endocrine systems, are becoming increasingly common," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "Our EMPOWER clinical trial program, which is exploring the impact of Jardiance across the spectrum of cardio-renal-metabolic conditions, is one of the broadest and most comprehensive of any SGLT2 inhibitor. Through our research we aim to contribute new knowledge that can help improve outcomes for the millions of people affected by these conditions."
禮來公司產品開發部副主任、醫學博士Jeff·埃米克説：“心臟-腎臟-代謝疾病--一組影響心臟、腎臟和內分泌系統的疾病--正變得越來越常見。我們的Empower臨牀試驗計劃正在探索Jardiance對心腎代謝疾病的影響，是所有SGLT2抑制劑中最廣泛和最全面的之一。通過我們的研究，我們的目標是提供新的知識，幫助受這些疾病影響的數百萬人改善結果。
AboutEMPERIALEMPERIAL 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.
EMPERIALEMPERIAL由兩個第三階段隨機雙盲試驗組成，試驗對象為患有或不患有糖尿病的成年人。這些試驗評估了與安慰劑相比，每天服用一次Jardiance 10毫克的12周治療對射血分數保留或減少的慢性心力衰竭患者的運動能力和心力衰竭症狀的影響。*主要終點是通過6分鐘步行測試來衡量的，6分鐘步行測試是一種常見的運動能力衡量標準。
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.
EMPERIAL-保留[NCT03448406]目的：探討射血分數(HFpEF)保留的慢性心力衰竭患者的心血管功能。這項研究考察了功能終點--患者在六分鐘內可以走多遠--以及心力衰竭症狀。
Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
主要終點：運動能力從基線改為第12周，以6分鐘步行距離衡量
Number of patients enrolled: 315
入選人數：315人
Completed: October 9, 2019
完成日期：2019年10月9日
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.
EMPERIAL-簡化[NCT03448419]：調查了慢性心力衰竭患者射血分數降低(HFrEF)的情況。這項研究考察了功能終點--患者在六分鐘內可以走多遠--以及心力衰竭症狀。
Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
主要終點：運動能力從基線改為第12周，以6分鐘步行距離衡量
Number of patients enrolled: 312
入選人數：312人
Completed: October 7, 2019
完成日期：2019年10月7日
*Ejection fractionis 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.
*射血分數是以心臟每次收縮時流出的血量的百分比表示的，與心腔的總血量有關。在每個心跳跳動週期中，心臟收縮和放鬆。當心髒收縮時，它從兩個泵室(腦室)排出血液。當心髒放鬆時，腦室就會充滿血液。
HFpEFoccurs 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.
當心肌收縮正常，但心室肌僵硬時，就會發生HFpEF。當腦室充滿血液時，他們不會像應該的那樣放鬆，因此與正常功能的心臟相比，可以進入心臟的血液更少。
HFrEFoccurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.
與功能正常的心臟相比，當心髒肌肉不能有效收縮，泵送到身體的血液較少時，就會發生心臟功能衰竭。
Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.
HFpEF和HFrEF都會導致類似的心力衰竭症狀，特別是呼吸困難、腫脹和疲勞。
About EMPOWERThe EMPOWER program reinforces the long-term commitment of Boehringer Ingelheim and Eli Lilly and Company to evaluate the potential of Jardiance to improve outcomes for adults living with cardio-renal-metabolic conditions. EMPOWER is one of the largest clinical trial programs for an SGLT2 inhibitor to date with more than 13,000 adults worldwide.
EMPOWER計劃加強了勃林格-英格爾海姆公司和禮來公司的長期承諾，以評估Jardiance改善患有心腎代謝疾病的成年人的結果的潛力。Empower是迄今為止規模最大的SGLT2抑制劑臨牀試驗計劃之一，全球有超過13,000名成年人蔘加。
The development program encompasses:
發展計劃包括：
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
在慢性心力衰竭患者中，降低射血分數以降低因心力衰竭而導致的心血管死亡和住院風險
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
帝皇保藏，用於射血分數保留的成人慢性心力衰竭患者，以降低因心力衰竭而導致的心血管死亡和住院風險
EMPULSE, in adults hospitalized for acute heart failure to improve clinical and patient reported outcomes
EmPulse，用於因急性心力衰竭住院的成年人，以改善臨牀和患者報告的結果
EMPACT-MI, to improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction
Empact-MI，用於改善患有和不患有糖尿病的患有急性心肌梗死的成年人的預後並預防心力衰竭
EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death
腎臟--在已有慢性腎臟疾病的成年人中，以減少腎臟疾病的進展和心血管死亡的發生
EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to improve exercise ability and patient reported outcomes
EMPERIAL減少，在慢性心力衰竭患者中降低射血分數以改善運動能力和患者報告的結果
EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to improve exercise ability and patient reported outcomes
EMPERIAL保存，在有保留射血分數的成人慢性心力衰竭患者中改善運動能力和患者報告的結果
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
在患有2型糖尿病和已有心血管疾病的成年人中，EMPA-REG結果®可降低包括心血管死亡在內的主要不良心血管事件的風險
EMPRISE, assessing comparative efficacy, safety, healthcare resource utilization and costs of care in routine clinical care in adult patients with diabetes
評估成人糖尿病患者常規臨牀護理的有效性、安全性、醫療資源利用率和護理成本
About Heart FailureHeart 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.
關於心力衰竭心力衰竭是一種進行性的、衰弱的、可能致命的疾病，當心髒不能提供足夠的循環來滿足身體對含氧血液的需求時，或者為了做到這一點，需要增加血量，導致肺部和外周組織中的液體積累(充血)。這是一種影響全球6000萬人的普遍疾病，隨着人口老齡化，預計還會增加。心力衰竭在糖尿病患者中非常普遍；然而，大約一半的心力衰竭患者沒有糖尿病。
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.
Jardiance心力衰竭計劃是基於EMPA-REG結果試驗的數據發起的，該試驗評估了與添加安慰劑相比，在護理標準中添加Jardiance的效果。Empa-REG結果是第一個SGLT2抑制劑試驗，表明在患有2型糖尿病和既往心血管疾病的成年人中，心血管死亡的風險相對降低。這一人羣包括超過45%的既往有心肌梗死的成年人。
About Cardio-Renal-Metabolic ConditionsCardio-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.
關於心腎代謝疾病心腎代謝疾病是一組相互關聯的疾病，影響心臟、腎臟和內分泌系統。總體而言，這些疾病是全世界主要的死亡原因，每年造成多達2000萬人死亡。這一組的疾病包括冠狀動脈疾病、心力衰竭、慢性腎臟疾病和2型糖尿病等。
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.
有關心腎和代謝系統之間聯繫的新興科學支持採取多學科方法為患有這些疾病的人制定診斷、預防和治療策略。我們仍然致力於開發具有廣泛的心腎代謝影響的治療方法，這可能有助於改善患有此類嚴重慢性病的患者的預後。
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.
什麼是JARDIANCE？(www.jardiance.com)JARDIANCE是一種處方藥，與飲食和運動一起用於降低成人2型糖尿病患者的血糖。
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
Jardiance還用於降低已知心血管疾病的2型糖尿病成人的心血管死亡風險。
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Jardiance不適用於1型糖尿病患者或糖尿病酮症酸中毒患者(血液或尿液中增加的酮體)。
IMPORTANT SAFETY INFORMATIONDo not takeJARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
重要安全信息如果你對雅培或雅培中的任何成分過敏，請不要服用雅培。
Do not takeJARDIANCE if you have severe kidney problems or are on dialysis.
如果您有嚴重的腎臟問題或正在進行透析，請不要服用JARDIANCE。
JARDIANCE can cause serious side effects, including:
賈迪昂斯可能會導致嚴重的副作用，包括：
Dehydration. JARDIANCEcan 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.
脱水。JARDIANCE會導致一些人脱水(身體水分和鹽分的喪失)。脱水可能會使你感到頭暈、頭暈、頭暈或虛弱，特別是當你站起來的時候。
You may be at a higher risk of dehydration if you:
如果你有以下情況，你可能會有更高的脱水風險：
have low blood pressure
有低血壓
take medicines to lower your blood pressure, including water pills (diuretics)
服用藥物降低血壓，包括水丸(利尿劑)
are on a low salt diet
正在進行低鹽飲食
have kidney problems
有腎臟問題
are 65 years of age or older
年齡在65歲或以上
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.
陰道酵母菌感染。服用JARDIANCE的婦女可能會患上陰道酵母菌感染。如果你有陰道異味，陰道分泌物白色或黃色(分泌物可能是塊狀的或看起來像白乾酪)，和/或陰道瘙癢，請諮詢你的醫生。
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.
陰莖的酵母菌感染。服用JARDIANCE的男性可能會患上陰莖周圍皮膚的酵母菌感染，特別是未割包皮的男性和患有慢性感染的男性。如果你遇到陰莖發紅、瘙癢或腫脹、陰莖皮疹、陰莖惡臭分泌物和/或陰莖周圍皮膚疼痛的情況，請向醫生諮詢。
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:
酮症酸中毒(血液或尿液中的酮體增多)。酮症酸中毒是一種嚴重的疾病，可能需要在醫院治療。酮症酸中毒可能導致死亡。酮症酸中毒發生在1型糖尿病患者中，也可能發生在服用JARDIANCE的2型糖尿病患者中，即使血糖低於250 mg/dL。在服用JARDIANCE期間患病或接受手術的糖尿病患者也會發生酮症酸中毒。停止服用JARDIANCE，如果出現以下任何症狀，立即打電話給醫生，如果可能，檢查尿中酮：
nausea
噁心
vomiting
嘔吐
stomach-area (abdominal) pain
胃區(腹痛)
tiredness
疲倦
trouble breathing
呼吸困難
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.
腎臟問題。服用JARDIANCE的人曾發生過突然的腎臟損傷。如果你減少了進食量或飲料量，或者如果你失去了液體，例如，嘔吐、腹瀉或在陽光下呆得太久，請立即與你的醫生交談。
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.
嚴重的尿路感染。服用JARDIANCE的人可能會發生嚴重的尿路感染，並可能導致住院治療。如果你有尿路感染的症狀，比如小便時有灼熱感，需要經常或馬上小便，胃下半部分或骨盆疼痛，或尿液有血，請告訴醫生。有時人們還可能發燒、背痛、噁心或嘔吐。
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:
低血糖(低血糖)：如果你與另一種可能導致低血糖的藥物(如磺脲或胰島素)一起服用JARDIANCE，你患低血糖的風險更高。你的磺脲或胰島素的劑量可能需要降低。低血糖症狀可能包括：
headache
頭痛
drowsiness
睏倦
weakness
軟肋
dizziness
頭暈
confusion
混亂
irritability
易怒
hunger
飢餓
fast heartbeat
快速心跳
sweating
出汗
shaking or feeling jittery
顫抖或感到緊張
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).
壞死性筋膜炎。一種罕見但嚴重的細菌感染，對肛門和生殖器(會陰)之間和周圍的皮膚下組織造成損害。這種細菌感染髮生在服用JARDIANCE的女性和男性身上，可能導致住院、多次手術和死亡。如果你發燒或感到非常虛弱、疲倦或不適(身體不適)，立即就醫，你在肛門和生殖器之間和周圍區域出現以下任何症狀：疼痛或壓痛、腫脹和皮膚髮紅(紅斑)。
Allergic (hypersensitivity) reactions.Symptoms of serious allergic reactions to JARDIANCE may include:
過敏性(過敏性)反應。JARDIANCE的嚴重過敏反應症狀可能包括：
swelling of your face, lips, throat and other areas of your skin
面部、嘴脣、喉嚨和皮膚其他部位的腫脹
difficulty with swallowing or breathing
吞嚥或呼吸困難
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.
皮膚上隆起的紅色區域(麻疹)如果您有任何這些症狀，請停止服用JARDIANCE，並立即聯繫您的醫生或前往最近的急診室。
Increased fats in your blood (cholesterol).
增加血液中的脂肪(膽固醇)。
The most common side effects of JARDIANCEinclude urinary tract infections and yeast infections in females.
JARDIANCE最常見的副作用包括女性的尿路感染和酵母菌感染。
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
這些並不都是JARDIANCE可能的副作用。有關更多信息，請諮詢您的醫生或藥劑師。
Before taking JARDIANCE, tell your doctor if you:
在服用JARDIANCE之前，請告訴您的醫生：
have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE
有腎臟問題。你的醫生可能會在你服用JARDIANCE之前和治療期間進行血液測試來檢查你的腎臟
have liver problems
有肝臟問題
have a history of urinary tract infections or problems with urination
有尿路感染病史或排尿問題
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
要做手術了。你的醫生可能會在你做手術前停止你的手術。如果你要做手術，請諮詢你的醫生，關於何時停止服用JARDIANCE以及何時重新開始服用
are eating less or there is a change in your diet
是你吃得更少了，還是你的飲食發生了變化
have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
你的胰腺有問題，包括胰腺炎或胰腺手術
drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
經常飲酒，或在短期內大量飲酒(“狂飲”)
have any other medical conditions
有其他身體狀況嗎？
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
懷孕或計劃懷孕。賈迪斯可能會傷害你未出生的寶寶。如果您在JARDIANCE治療期間懷孕，請立即告知您的醫生
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
正在母乳餵養或計劃母乳餵養。賈迪斯可能會進入你的母乳，可能會傷害你的寶寶。服用JARDIANCE時不要母乳餵養
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.
告訴你的醫生你服用的所有藥物，包括處方藥和非處方藥、維生素和草藥補充劑。如果你服用水丸(利尿劑)或能降低血糖的藥物，如胰島素，尤其要告訴你的醫生。
You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatchor call 1-800-FDA-1088.For more information, please seePrescribing InformationandMedication Guide.
我們鼓勵您向FDA報告處方藥的負面副作用。請訪問www.fda.gov/medwatchor致電1-800-FDA-1088。有關更多信息，請參閲《預描述信息和藥物指南》。
CL-JAR-100057 01.27.2020
CL-JAR-100057 01.27.2020
Boehringer Ingelheim and Eli Lilly and CompanyIn January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.
伯林格-英格爾海姆公司和禮來公司2011年1月，勃林格-英格爾海姆公司和禮來公司宣佈了一項以代表幾個最大的糖尿病治療類別的化合物為核心的聯盟。根據地理位置的不同，這些公司要麼共同促進，要麼單獨促進各自對聯盟做出貢獻的分子。該聯盟利用兩家世界領先的製藥公司的優勢，專注於患者的需求。通過聯合起來，兩家公司展示了他們的承諾，不僅是對糖尿病患者的護理，而且是對解決未得到滿足的醫療需求領域的潛力進行調查。臨牀試驗已經啟動，以評估Jardiance對患有心力衰竭或慢性腎臟疾病的患者的影響。
About Boehringer IngelheimMaking new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.
關於勃林格英格爾海姆為人類和動物製造新的更好的藥物是我們所做工作的核心。我們的使命是創造改變生活的突破性療法。自1885年成立以來，勃林格-英格爾海姆一直是獨立的家族企業。我們有自由追求我們的長期願景，展望未來，確定未來的健康挑戰，並針對我們可以做最好的需要的領域。
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.
作為一家世界領先的研究驅動型製藥公司，超過51,000名員工每天通過創新為我們的三個業務領域創造價值：人類製藥、動物健康和生物製藥合同製造。2019年，勃林格-英格爾海姆實現了約213億美元(190億歐元)的淨銷售額。我們在研發方面的重大投資超過39億美元(35億歐元)，推動創新，使下一代藥物能夠拯救生命並提高生活質量。
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
我們通過擁抱夥伴關係的力量和生命科學界專家的多樣性，實現了更多的科學機會。通過共同努力，我們加快了下一項醫學突破的交付，這將改變現在和未來幾代患者的生活。
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visitwww.boehringer-ingelheim.us/csrto learn more about Corporate Social Responsibility initiatives.
勃林格-英格爾海姆製藥公司總部設在康涅狄格州里奇菲爾德，是勃林格-英格爾海姆公司在美國最大的子公司，也是勃林格-英格爾海姆集團公司的一部分。此外，還有位於佐治亞州德盧斯的勃林格-英格爾海姆動物健康公司和位於加利福尼亞州弗裏蒙特的勃林格-英格爾海姆-弗裏蒙特公司。請訪問www.boehringer-ingelheim.us/csr瞭解更多有關企業社會責任倡議的信息。
For more information, please visitwww.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
欲瞭解更多信息，請訪問www.boehringer-ingelheim.us，或通過Twitter@BoehringerUS關注我們。
About Lilly DiabetesLilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visithttp://www.lillydiabetes.com/or follow us on Twitter:@LillyDiabetesand Facebook:LillyDiabetesUS.
About Eli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.comandnewsroom.lilly.com/social-channels.
禮來公司簡介禮來公司是一家全球醫療保健領先者，將關懷與發現結合在一起，為世界各地的人們創造更好的生活。我們是一個多世紀前由一位致力於創造滿足實際需求的高質量藥物的人創建的，今天我們在所有工作中仍然忠於這一使命。在全球範圍內，禮來公司的員工緻力於發現改變生活的藥物，並將其帶給需要它們的人，改善對疾病的理解和管理，並通過慈善和志願服務回饋社區。欲瞭解有關禮來公司的更多信息，請訪問我們的atwww.lilly.comandnewsroom.lilly.com/social-channels.
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 Lilly's current belief.However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
本新聞稿包含關於Jardiance的前瞻性陳述(該術語在1995年的私人證券訴訟改革法案中定義)，並反映了禮來公司目前的信念。然而，與任何製藥產品一樣，藥物開發和商業化過程中存在重大風險和不確定性。除其他事項外，不能保證未來的研究結果將與迄今的結果一致，也不能保證Jardiance將獲得額外的監管批准。有關這些和其他可能導致實際結果與禮來公司預期不同的風險和不確定性的進一步討論，請參閲禮來公司提交給美國證券交易委員會的最新10-K和10-Q表格。禮來公司不承擔更新前瞻性陳述的責任。
Jardiance®and EMPA-REG OUTCOME®are registered trademarks of Boehringer Ingelheim.
JADIANCE®和EMPA-REG OUTURE®是勃林格-英格爾海姆的註冊商標。
P-LLYMPR-US-101285
P-LLYMPR-US-101285
CONTACT:Jennifer ForsythDirector, Public RelationsBoehringer Ingelheim Pharmaceuticals, Inc.Email:jennifer.forsyth@boehringer-ingelheim.comPhone: (203) 791-5889
珍妮弗·福賽斯公共關係部主任伯林格·英格爾海姆製藥公司Inc.Email:jennifer.forsyth@boehringer-ingelheim.comPhone：
Stephan ThalenGlobal Business CommunicationsLilly Diabetes and Lilly USAEmail:stephan.thalen@lilly.comPhone: (317) 903-5640
禮來公司糖尿病和禮來公司電子郵件：stephan.thalen@lilly.com電話：(317)903-5640
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SOURCE Eli Lilly and Company
來源：禮來公司
譯文內容由第三人軟體翻譯。