Forxiga approved in China to reduce the risk of cardiovascular death and hospitalisation in adult patients with symptomatic chronic heart failure

The first and only heart failure therapy with a proven mortality benefit now approved for patients with heart failure regardless of ejection fraction status
 

Forxiga 达格列净(dapagliflozin)已在中国被批准用于降低心血管死亡风险, 心力衰竭住院(HF), 或有症状的慢性心衰成人的紧急心衰就诊. Forxiga has previously been approved in China for HF patients with reduced ejection fraction (HFrEF) meaning that Forxiga is now approved in China to reduce the risk of cardiovascular death and hospitalisations in adult patients with symptomatic chronic HF regardless of ejection fraction phenotype.

The approval by China’s National Medical Products Administration (NMPA) is based on positive results from the 交付 Phase III trial. Results from the prespecified pooled analysis of 交付 and DAPA-HF Phase III trials also established dapagliflozin as the first HF medication to demonstrate a mortality benefit across the full ejection fraction range.^1,2

路德浮标, 执行副总裁, 澳门葡京赌博游戏业务部总裁, 澳门葡京网赌游戏, 他说:“这一更广泛的迹象表明 Forxiga in adults with symptomatic chronic heart failure across the full ejection fraction range is a significant advancement for patients. It represents an exciting turning point in the battle against heart failure given the unmet treatment needs and the absence until now of treatments that reduce mortality in this setting. 重要的是, this 发展 underscores our commitment to accelerating earlier detection and coordinated care, 为了解决各种疾病范围内心力衰竭的复杂性.”

心衰是一种复杂的综合征，当心脏不能向全身泵出足够的血液时就会发生.³ HF大约影响4.中国有500万人口.⁴ 大约一半的心衰患者在确诊后五年内死亡.⁵ Patients with ejection fraction above 40% are at greater risk of death and hospitalisation and experience an especially high burden of symptoms and physical limitations, 因此他们的生活质量很差.⁶ 在中国，心衰的经济负担在医疗成本和资源利用方面是巨大的, and hospitalisation is the major contributor to the HF treatment burden - the mean hospital stay for HF patients is 30 days in one year.⁷

Forxiga 也被批准用于治疗T2D患者, HFrEF和CKD在全球100多个国家，包括中国, 日本, 美国, 和欧盟.

笔记

心脏衰竭
心力衰竭(HF)是一种慢性、长期的疾病，会随着时间的推移而恶化.⁸ 它影响着全球近6400万人⁹ 它与大量的发病率和死亡率有关.¹⁰ Chronic HF is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.¹¹ HF有几种类型，通常由左室射血分数(LVEF)来定义。, 测量心脏每次收缩时血液流出的百分比, 包括HFrEF (LVEF小于或等于40%), HFmrEF (LVEF 41-49%)和HFpEF (LVEF大于等于50%).¹² Approximately half of all HF patients have HFmrEF or HFpEF, with few therapeutic options available.¹³

交付 
交付 (Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction 心脏衰竭) was an international, 随机, 双盲, 与这些相应平行的组织, 安慰剂对照, 事件驱动的III期试验旨在评估 Forxiga, 与安慰剂相比, 治疗LVEF大于40%的HF患者, 伴有或不伴有2型糖尿病(T2D). 交付是迄今为止LVEF高于40%的HF患者中规模最大的临床试验, 与6,263名随机患者.¹⁴ 交付 III期临床试验的结果显示 Forxiga met its primary endpoint in reducing the composite outcome of cardiovascular (CV) death or worsening HF by 18% (16.4% Forxiga 第19组.在中位随访2年期间，安慰剂组有5%.3年[风险比{HR} =0.82 {95% CI 0.73-0.92}; p<0.001, ar3.1%]).¹⁴

DAPA-HF 
DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in 心脏衰竭) was an international, 的多中心, 与这些相应平行的组织, 随机, 双盲III期临床试验4年,744例HFrEF患者, 不论有无T2D, 评价的:用来评价…的效果的 Forxiga 10mg，与安慰剂相比，在标准治疗的基础上每天给予一次. The primary composite endpoint was time to the first occurrence of a worsening HF event (hospitalisation or equivalent event, i.e.(如紧急心衰就诊)或心血管(CV)死亡. 中位随访时间为18.2个月.¹⁵ Key secondary endpoints included the total number of hospitalisations for HF (hHF) (including repeat admissions) and CV deaths, change from baseline to 8 months in the total symptom score on the Kansas City Cardiomyopathy Questionnaire (KCCQ).¹⁵

Forxiga (dapagliflozin)
Forxiga 是头等舱吗, 口服, 人钠-葡萄糖共转运蛋白2 (SGLT2)选择性抑制剂. Forxiga 是否可降低心血管死亡风险, HF住院, 或有症状的慢性心力衰竭的成年人的紧急HF就诊.¹⁶ Forxiga is also approved in China for adults with chronic kidney disease (CKD) and for the treatment of insufficiently controlled type 2 diabetes (T2D) as an adjunct to diet and exercise.  研究表明  Forxiga的 预防和延缓心肾疾病的疗效, while also protecting the organs – important findings given the underlying links between the heart, 肾脏, 和胰腺.^{15, 17-18} 其中一个器官受损会导致其他器官衰竭, 是全世界的主要死亡原因, 包括T2D, HF, 和慢性肾病.^{3, 9, 19-20}

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