2020年11月30日07:00 GMT
Forxiga is the first SGLT2 inhibitor approved in Japan for chronic 心 failure with reduced ejection fraction in adult patients with and without type-2 diabetes
澳门在线赌城娱乐公司 Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic 心 failure (HF) who are receiving standard of care.
HF is a life-threatening chronic disease that prevents the 心 from pumping sufficient levels of blood around the body. It affects approximately 64 million people worldwide, at least half of whom have a reduced ejection fraction.1-3 This occurs when the left ventricle muscle is not able to contract adequately and t在这里fore 向体内排出的富氧血液较少.4-6
经日本厚生劳动省批准, Labour and Welfare (MHLW) was based on positive results from the landmark DAPA-HF Phase III trial published in 新英格兰医学杂志.7
正文Kitakaze, 韩华大日仙福医院院长, Guest Professor of the Graduate School of Medicine, University of Osaka and Investigator of the DAPA-HF Phase III trial in Japan, 他说:“心力衰竭是一种影响人类健康的疾病.日本有300万人口. Many patients have considerably reduced 心 function, such as left ventricular reduced ejection fraction. Approximately half of patients will die within five years of diagnosis, 哪种癌症比某些癌症更糟糕. 除了心脏移植，目前还没有治愈方法, a new effective treatment option on top of the current standard of care may offer hope for people struggling with this disease and a new tool for cardiologists.”
Mene Pangalos, Executive Vice President, 澳门第一赌城在线娱乐 R&D，说:Forxiga’s efficacy in reducing the risk of cardiovascular death or worsening of 心 failure events could result in life-saving benefits for many 心 failure patients in Japan. Today’s approval will shift the way we manage the disease by providing a treatment option that is urgently needed to improve outcomes and symptoms for these patients.”
Forxiga is the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to have shown a statistically significant reduction in the risk of the composite of cardiovascular (CV) death or worsening of HF events, 包括因心衰住院(hHF). DAPA-HF III期试验表明 Forxiga, 除了标准护理之外, reduced the risk of the composite outcome versus placebo by 26% and both components of the primary composite endpoint contributed benefit to the overall effect.
In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine. 审判期间, one CV death or hHF or an urgent visit resulting in intravenous therapy associated with HF could be avoided for every 21 patients treated.
Forxiga (被称为 Farxiga 在美国被批准 US, 欧洲, and several other countries around the world for the treatment of patients with HF with reduced ejection fraction (HFrEF).
Forxiga is advancing cardiorenal prevention as science continues to identify the underlying links between the 心, 肾脏和胰腺. DAPA-HF是DapaCare的一部分, a robust clinical trial programme to assess the potential CV and renal benefits of Forxiga. The programme has also explored the treatment of patients with chronic kidney disease (CKD) in the ground-breaking DAPA-CKD Phase III trial. 此外, Forxiga is currently being tested for HF patients with preserved ejection fraction (HFpEF) in the DELIVER Phase III trial with data readout anticipated in the second half of 2021.
2013年，澳门在线赌城娱乐K.K. (AZKK), a subsidiary in Japan of 澳门在线赌城娱乐, entered into an agreement with Ono Pharmaceutical for Forxiga. Based on this agreement, Ono is responsible for distribution and marketing of Forxiga tablets in Japan and has been co-promoting it with AZKK for the treatment of T2D and type-1 diabetes. Both companies will co-promote for the treatment of chronic 心 failure.
心脏衰竭
HF affects approximately 64 million people worldwide (at least half of whom have a reduced ejection fraction), 包括1.3 million in Japan, 15 million in the EU and six million in the US.2-3,8,9 It is a chronic disease w在这里 half of patients will die within five years of diagnosis.10 HFrEF and HFpEF are the two main categories of HF related to ejection fraction, a measurement of the percentage of blood leaving the 心 each time it contracts.7 HFrEF occurs when the left ventricle muscle is not able to contract adequately and t在这里fore, 向体内排出的富氧血液较少.5,6 HF remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancer).11 It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.12
DAPA-HF
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, 的多中心, 与这些相应平行的组织, 随机, 4例双盲试验,HFrEF (LVEF≤40%)744例, 不论有无T2D, 评价的:用来评价…的效果的 Forxiga 10mg, compared with placebo, given once daily 除了标准护理之外. The primary composite endpoint was time to the first occurrence of a worsening 心 failure event (hospitalisation or equivalent event, i.e. 紧急心力衰竭就诊)或CV死亡. 中位随访时间为18.2个月.
Forxiga
Forxiga (达格列净)是一流的, 口服, once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction.
Forxiga has been evaluated in patients with CKD in the Phase III DAPA-CKD trial, 随着全部结果的公布 2020年8月 证明 Forxiga met all primary and secondary endpoints, providing overwhelming efficacy. Forxiga is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) Phase III trials. Forxiga will also be tested in patients without T2D following an acute myocardial infarction (MI) or 心 attack in the DAPA-MI trial - a first of its kind, indication-seeking registry-based 随机 controlled trial. Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000名患者, 以及超过2个.500万病人年的经验.
澳门在线赌城娱乐在crvrm
心血管，肾脏和代谢 (CVRM) together forms one of 澳门在线赌城娱乐公司 three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the 心, 肾脏和胰腺, 澳门在线赌城娱乐 is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, 减少风险和处理合并症. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.
澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在推特上关注公司 @澳门在线赌城娱乐.
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参考文献
1. 梅奥诊所. 心脏衰竭; 29 May 2020 [cited 21 October 2020]. 可从:URL: http://www.mayoclinic.org/diseases-conditions/心-failure/symptoms-causes/syc-20373142.
2. Vos T等. 全球, 区域, 全国发病率, 患病率, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the 全球 Burden of Disease Study 2016. 《澳门第一赌城在线娱乐》2017; 390(10100):1211–59.
3. Travessa AMR, Menezes falc
4. 美国心脏协会. Ejection Fraction Heart Failure Measurement; 2017 [cited 2 Nov 2020]. 可从:网址: http://www.心.org/en/health-topics/心-failure/diagnosing-心-failure/ejection-fraction-心-failure-measurement.
5. Ponikowski等. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic 心 failure: The Task Force for the diagnosis and treatment of acute and chronic 心 failure of the 欧洲an Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. 欧洲心脏 2016; 37(27):2129–200.
6. 国家指南中心(英国). Chronic Heart Failure in Adults: Diagnosis and Management. London: National Institute for Health and Care Excellence (UK); 2018 Sep. (NICE指南，No. 106.13、词汇表.
7. McMurray等. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. 英国医学杂志 2019.
8. 澳门在线赌城娱乐. 存档数据. 2020年11月.
9. 迪克斯坦K等人. ESC Guidelines for the diagnosis and treatment of acute and chronic 心 failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the 欧洲an Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the 欧洲an Society of Intensive Care Medicine (ESICM). 欧洲心脏 2008; 29:2388-2442.
10. Mozaffarian D等. 循环. 26 January 2016;133(4):e38-360 and the CDC: http://www.疾病预防控制中心.gov/dhdsp/data_statistics/fact_sheets/fs_心_failure.htm.
11. Mamas MA等. Do patients have worse outcomes in 心 failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. 心脏衰竭 2017; 19(9):1095–104.
12. Azad N, Lemay G. Management of chronic 心 failure in the older population. 老年心脏病 2014; 11(4):329–37.
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