28 October 2020 07:00 GMT
批准更新包括DECLARE-TIMI 58 III期试验，降低了风险
2型糖尿病患者因心力衰竭或心血管死亡住院的综合分析
中国国家药品监督管理局(NMPA)更新了澳门在线赌城娱乐(AstraZeneca)的标签 Forxiga (dapagliflozin)纳入DECLARE-TIMI 58 III期试验的数据.
DECLARE-TIMI 58 demonstrated that Forxiga 在因心力衰竭(hHF)或心血管(CV)死亡住院的复合终点方面取得了统计学上显著的降低, versus placebo, 患有2型糖尿病(T2D)并有心血管疾病或多种心血管危险因素的成人患者. The trial confirmed the well-established safety profile of Forxiga.1
DECLARE-TIMI 58是迄今为止进行的最大的钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂CV结果试验, and data from the trial were published in The New England Journal of Medicine in January 2019.
There are an estimated 463 million people living with diabetes worldwide, with nearly 120 million in China.2 T2D患者发生慢性心力衰竭(HF)的可能性是无T2D患者的2 - 5倍.3
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, 他说:“心力衰竭是2型糖尿病患者最常见的心血管并发症之一. The DECLARE-TIMI 58 Phase III data show that Forxiga reduces the risk of hospitalisation for heart failure and, with this label update, 澳门第一赌城在线娱乐期待着将这一重大成果带给中国的患者.”
Forxiga 作为单药治疗和联合治疗的一部分，可以改善成人T2D患者的血糖控制. The NMPA label update, based on the DECLARE-TIMI 58 Phase III data, follows the update to the EU marketing authorisation in August 2019 and the approval by the US Food and Drug Administration (FDA) in October 2019 of an indication for Forxiga (known as Farxiga in the US) 降低成人T2D合并CV疾病或多重CV危险因素的hHF风险.
In May 2020, Farxiga 在美国被批准用于降低成人HF (NYHA II-IV级)伴射血分数(HFrEF)降低(伴或不伴T2D)的CV死亡和hHF的风险, and in October 2020 Forxiga 是人用药品委员会推荐在欧盟批准HF的吗. Additionally, the FDA granted Farxiga Breakthrough Therapy Designation in October 2020 加速慢性肾脏疾病(CKD)患者的开发和监管审查, with and without T2D.
Type-2 diabetes
T2D是一种以病理生理缺陷导致血糖水平升高为特征的慢性疾病, or hyperglycaemia.2 随着时间的推移，这种持续的高血糖会导致疾病的进一步进展.2 预计到2030年，全球糖尿病患病率将达到5.78亿人, and 700 million by 2045.2 t2dm约占所有确诊糖尿病病例的90- 95%.4
DECLARE-TIMI 58
DECLARE-TIMI 58 is an AstraZeneca-sponsored, Phase III, randomised, double-blinded, placebo-controlled, multicentre trial designed to evaluate the effect of Forxiga 在心血管事件风险的成人T2D患者中，与安慰剂的CV结果进行比较, 包括有多种心血管危险因素或已确诊的心血管疾病的患者, and also assessed key renal secondary endpoints. The trial included more than 17,在33个国家的882个地点，000名患者，并与来自TIMI研究小组(波士顿)的学术研究人员合作独立运行, US) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).1
Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, 每日一次的SGLT2抑制剂适用于成人治疗控制不足的T2D，可作为单一治疗和联合治疗的一部分，作为饮食和运动的辅助治疗，以改善血糖控制, 还有额外的减肥和降血压的好处.
Forxiga has been evaluated in patients with CKD in the Phase III DAPA-CKD trial, with the full results announced in August 2020 demonstrating that Forxiga met all primary and secondary endpoints, providing overwhelming efficacy. Forxiga 目前正在对DELIVER(保留射血分数的HF)患者进行试验, HFpEF) and DETERMINE (HFrEF and HFpEF) Phase III trials. Forxiga 在DAPA-MI试验中，也将在急性心肌梗死(MI)或心脏病发作后无T2D的患者中进行测试，这是同类试验的首例, indication-seeking registry-based randomised controlled trial. Forxiga 拥有强大的临床试验计划，包括超过35项已完成和正在进行的IIb/III期试验,000 patients, as well as more than 2.5 million patient-years’ experience.
AstraZeneca in CVRM
Cardiovascular, 肾脏和代谢(CVRM)共同构成澳门在线赌城娱乐的三大治疗领域之一，是公司的关键增长动力. 通过遵循科学来更清楚地了解心脏之间的潜在联系, kidneys and pancreas, 澳门在线赌城娱乐正在投资一系列药物，以保护器官，并通过减缓疾病进展来改善结果, reducing risks and tackling comorbidities. 该公司的目标是改变或停止crvrm疾病的自然过程，并可能使器官再生和恢复功能, 通过继续提供变革性的科学，改善全球数百万患者的治疗实践和心血管健康.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, 主要用于治疗肿瘤等三个治疗领域的疾病, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. Please visit hebhgkq.com and follow the Company on Twitter @AstraZeneca.
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References
1. Wiviott SD et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2019; 380(4):347–57.
2. International Diabetes Federation. IDF Diabetes Atlas Ninth Edition 2019. Available from: URL: http://diabetesatlas.org/upload/resources/material/20200302_133351_IDFATLAS9e-final-web.pdf (Accessed 25 October 2020).
3. Ofstad AP et al. 2型糖尿病的心力衰竭负担——病理生理学和干预措施综述. Heart Fail Rev 2018; 23(3):303–23.
4. Centers for Disease Control and Prevention (CDC). Diabetes Fast Facts. Available from: URL: http://www.cdc.gov/diabetes/basics/quick-facts.html (Accessed 25 October 2020).
Adrian Kemp
Company Secretary
AstraZeneca PLC