人類處方藥物｜複雜且高度相關疾病的研究結果 Research-led results for interconnected complex diseases
心臟、腎臟與代謝的疾病可能存在複雜的相互關係，患者的性別也可能影響病徵的呈現，同時也在診斷中佔有一席之地。而百靈佳殷格翰致力探究這類關聯性，以及Jardiance®恩排糖用於新型治療的研究潛能。
腎臟疾病是全球性的公共衛生問題，影響了近8.5億人，相當於超過十分之一的成年人口。
在Pamela Thomas 的早年生活中，她的先天性心臟病並未對她產生太大的困擾，她在工作與運動中，都過著相對正常的生活。但在38歲時，她開始出現胸痛、雙腳腫脹，甚至數次的昏厥。
「這些嚴重的症狀讓我感到害怕。」Thomas女士回憶道。而她的醫生則安撫她，表示昏厥不一定是個大問題，腳腫的症狀可能只是飲食上攝取過多的鹽分。對此，Thomas女士認為：「我感覺自己沒有被認真對待，因此更加焦慮了。」
兩週不到的時間，她的身體積聚了大量的液體，使她的體重明顯增加。一位心臟專科醫生下令讓她搭乘救護車送往醫院，並從她的胸腔抽取了1.7升的積水。「當我從麻醉中醒來，我感覺輕鬆許多了。」Thomas女士說道。
十四年後，歷經了數次心臟手術的Thomas女士，現在已成功控制她的心臟問題。現在的她，積極參與為患有心臟疾病的女性發聲的團體WomenHeart.org的行動。
因為有像Thomas女士這樣的人存在，百靈佳殷格翰才能成為全球心臟疾病及相關症領域中長期領導者，並致力開發有效的治療方法。其中，涵蓋了自2016年開始的臨床試驗，以及與Eli Lilly合作的EMPOWER的計劃。
預防腎臟疾病進程與降低心血管風險，仍是臨床中一件重大但尚未解決的課題。
相互關聯的疾病
Thomas女士過往的疾病與治療經驗，彰顯了在早期階段正確識別及治療複雜疾病的困難性，她的故事也顯示出女性經常被誤診的情況。
據研究顯示，女性正確檢測出心臟衰竭的時間上比男性更長，誤診狀況更是男性的兩倍，上述狀況也讓女性因診斷結果引發抑鬱症的風險增加了50%，因此有效地控管這些病狀對於心理健康至關重要。
除了性別的因素外，導致診斷困難的原因有很多，例如：呼吸短促、體力下降等不一定代表心臟有問題。而心臟功能不全通常與其他疾病有關，尤其是第二型糖尿病。
第二型糖尿病是一種影響深遠的代謝疾病，血液中若有過多的糖分，將導致血管內的脂肪沉積和動脈狹窄，而冠狀動脈越狹窄，送達全身的氧氣就越少，心臟受損的風險將因此提高。糖尿病患者的心臟也可能積聚脂肪，進一步損害這個重要的器官。
此外，糖尿病也可能對腎臟造成損害，因腎臟的重要功能是過濾有害物質，並透過尿液排出體外，所以血液中過多的糖分或循環問題，可能損害腎臟的功能。
百靈佳殷格翰與Eli Lilly的EMPOWER將持續研究糖尿病、心臟與腎臟疾病之間的相互關係。
慢性腎臟病與多種代謝及心血管疾病密切相關。
最新研究顯示，empagliflozin也對腎臟疾病有益處，且不受患者是否有糖尿病的影響（參見資訊欄）。
每年全球有500萬至1000萬人死於慢性腎臟疾病。
到我們的網站中，了解更多關於心臟、腎臟與代謝系統的相互關係。
克服診斷上性別偏差的需求
在Thomas女士的案例中，凸顯考量性別的重要，是讓醫療方法更全面的因素之一。然而，專家指出，女性經常無法獲得準確的診斷及適當的治療，這個問題亟需解決。
美國預防心臟病學會主席Martha Gulati強調：「藥物的臨床試驗對象多為男性，而女性的參與相對不足，尤其是在心臟衰竭的領域。」醫學界需要更多納入女性樣本的疾病研究與了解，才能確保女性能夠獲得準確且適當的治療，並消除性別偏見的影響。
根據Gulati博士的說法，研究顯示了其結果不足以充分反映性別間的生理差異，例如：女性的心臟收縮分率天生高於男性，因此女性的心臟病患者，其收縮分率可能看似正常，實際上卻是偏低的。
性別的差異，也影響了第二型糖尿病與心臟疾病間的關係，Gulati博士表示，患有糖尿病的女性，導致心臟疾病發生的機率高於男性。儘管風險因素各有不同，但心臟衰竭無論男女都有嚴重的影響。
而這些研究疾病之間的相互關係、消除臨床實驗中的性別偏見，正是使百靈佳殷格翰持續追求並改善複合性疾病相互關係研究的主要動力。
持續進行突破性的研究
一項名為EMPA-KIDNEY 的追蹤研究，取得了令人振奮的結果，讓計畫提前完成，該研究的詳細結果在2022年11月公開發表。共有6,600名患有不同腎臟疾病的人參與研究，樣本也包含了糖尿病病患與非糖尿病病患。
全球有近8.5億人患有腎臟疾病，其中多數人接受透析治療，這對他們的日常生活造成了相當大的影響。慢性腎樣病也是導致死亡的主要原因之一：全球每年有五到一千萬人死於這類疾病，而EMPA-KIDNEY的研究結果，將為患有腎臟疾病的人帶來更好的生活。
HUMAN PHARMA
Research-led results for interconnected complex diseases
Cardiac, renal and metabolic diseases can have complex interdependencies. A patient’s gender can affect the way the symptoms manifest themselves – while also playing a role in diagnosis. Boehringer Ingelheim continues to drive research into these relationships and potentially new therapeutic uses for its drug Jardiance.
Kidney disease is a global public health issue, affecting nearly 850 million people — more than 1 in 10 adults.
For much of her early life, Pamela Thomas’s congenital heart defect didn’t really bother her. She worked, exercised and led a generally normal life. But at age 38, she began experiencing chest pains, her feet started to retain water, and she even fainted a few times.
“These serious symptoms scared me,” Ms. Thomas recalls. Her doctor sought to calm her, saying that the fainting wasn’t necessarily a worry and that her feet were probably swollen because there was too much salt in her diet. “I didn’t feel like I was taken seriously and was completely unsettled,” Ms. Thomas says.
Within two weeks, her body had retained so much fluid that she had gained a noticeable amount of weight. A cardiologist ordered her rushed by ambulance to a hospital — where 1.7 liters of water were drained from her chest. “When I woke up from the sedation, I felt free,” says Thomas.
Fourteen years and several cardiac surgeries later, Ms. Thomas has her heart problems under control. She is now active in WomenHeart.org, an advocacy group for women with heart disease.
People like Ms. Thomas are a reason that Boehringer Ingelheim is a long-time leader in global research involving heart disease and related conditions in order to develop effective therapies. That includes a series of clinical trials tracing to 2016, a program called EMPOWER, in collaboration with Eli Lilly.
Prevention of kidney disease progression and reduction of cardiovascular risk remain significant unmet clinical needs.
Interdependent diseases
Ms. Thomas’s health history shows how difficult it can be to identify complex conditions at an early stage and treat them properly. Her story also indicates that women, in particular, are often misdiagnosed.
Research has shown that heart failure takes longer to be detected in women than in men and that misdiagnosis occurs twice as often. And because the risk of women suffering depression as a result of the diagnosis is 50 percent higher, effectively managing such conditions is crucial to mental health.
Gender aside, there are many reasons for elusive diagnoses. Symptoms such as shortness of breath or impaired performance don’t necessarily point toward heart problems. Furthermore, cardiac insufficiency is often related to other diseases, particularly type 2 diabetes.
Type 2 diabetes, a metabolic disease, has a far-reaching impact. Too much sugar in the blood can lead to fatty deposits in blood vessels and narrowing of arteries. The narrower the coronary arteries, the less oxygen received throughout the body and the greater the risk of a heart attack. Fatty deposits can also build up in the hearts of diabetes patients, further harming the vital organ.
Diabetes, moreover, can also harm the kidneys — whose crucial job it is to filter harmful substances and excrete them from the body through the urine. Too much sugar in the blood, or circulation problems, can impair the function of the kidneys.
There are links between diabetes and diseases of the heart and kidney. Boehringer Ingelheim and Eli Lilly’s EMPOWER studies will continue to research their interdependencies.
Chronic kidney disease is closely linked with several metabolic and cardiovascular diseases.
The medicine works regardless of whether the patients suffer from diabetes. New studies show that empagliflozin can also help with certain renal disorders, even if the patients do not suffer from diabetes (See infobox).
Worldwide, 5 to 10 million people die each year from chronic kidney disease.
Learn more about the Interconnectivity of the Heart, Kidney an Metabolic Systems at our website.
The need to overcome gender bias
The importance of a holistic medical approach is illustrated by Ms. Thomas’s case, because gender can also play a role if a disease is to be properly treated. And too often, experts say, women are not given accurate diagnoses or sufficient treatments.
Martha Gulati, President of the American Society for Preventive Cardiology, points out that drugs are predominantly tested on men. “Women are still underrepresented in clinical studies,’’ Dr. Gulati says. “This is particularly true for heart failure.”
And so, according to Dr. Gulati, study results do not sufficiently reflect the biological differences between genders. For example, women’s hearts have a naturally higher ejection fraction than men’s. As a result, the ejection fraction of a woman with heart problems could appear normal even though it is actually too low.
Gender differences also impact the relationship between type 2 diabetes and heart conditions, with diabetes more often leading to heart disease in women than men, Dr. Gulati says. Ultimately, heart failure is equally debilitating to women and men — even if the risk factors differ.
For Boehringer Ingelheim, the interrelationships of these diseases and the need to eliminate gender biases in clinical trials, are major impetuses as the company continues to pursue — and improve — research on the causes and interdependencies of complex medical conditions.
Groundbreaking research continues
A follow-up study, EMPA-KIDNEY, led to such promising results that it was concluded ahead of schedule. Detailed results were publicly presented in November 2022. 6,600 people with various renal ailments took part in the EMPA-KIDNEY study, which included patients with and without diabetes..
Nearly 850 million people worldwide live with a renal disease. Many of them rely on dialysis, which has a considerable impact on their daily lives. Chronic kidney diseases are also a frequent cause of death: worldwide, between five and ten million people die from such diseases every year. These EMPA-KIDNEY results promise a better life for millions of people who suffer from renal disorders