在III阶段宣告 - TIMI 58试验的新预先指定的子分析中，Forxiga显示出肾脏疾病标记突出患者的相对风险降低（绝对风险降低= 8.3％）与安慰剂
AstraZeneca today announced a new pre-specified sub-analysis from theForxiga.（Dapagliflozin）III阶段宣告 - 表明药物的试验降低了在2型糖尿病（T2D）的心脏血管血管（CV）死亡或住院治疗心力衰竭（HHF）的相对风险（T2D）的患者的CV事件的风险，独立于两个突出的肾脏疾病标记的状态：估计肾小球过滤速率（EGFR）低于60毫升/分钟/ 1.73m2and presence of albuminuria. The analysis also showedForxiga.关于主要不良心血管事件（MACE）的发生是非较差的，与这些标志物无关。1
These data were presented today at ESC Congress 2019 in Paris, France.
高级副总裁ElisabethBjörk，心血管，肾脏和新陈代谢，生物制药研发，糖尿病的人数大约是发展慢性肾病的两倍，因为没有，2and renal dysfunction has been shown to predict cardiovascular outcomes.1The DECLARE-TIMI 58 results build on the extensive body of evidence forForxiga.作为患有高血管内风险的2型糖尿病患者的治疗，数据可以让医生对SGLT2抑制剂的信心等等Forxiga.,to treat this patient population.”
The DECLARE-TIMI 58 trial evaluated 17,160 patients with T2D at risk of CV events, of which 34.5% (5915) had manifestations of chronic kidney disease (CKD): 31.3% (5367) had either an eGFR <60 ml/min/1.73m² or albuminuria ([UACR] ≥ 30mg/g), 3.2% (548) had both manifestations. Patients with a Creatinine-Clearance < 60ml/min at enrolment were excluded from the study.1的sub-analysis前sented at the ESC Congress 2019 showed that patients with more abnormal markers had higher event rates for CV death/hHF (KM event rates at 4 years of 3.9%, 8.3%, 17.4%) or MACE (7.5%, 11.7%, and 18.9%) for no, one or two markers of CKD, respectively. The relative risk reductions versus placebo for CV death/hHF and MACE were generally consistent across the subgroups (both p-interaction >0.29), though numerically greatest (42%) in patients with both reduced eGFR and albuminuria.1
Forxiga.is an inhibitor of SGLT2 indicated in adults for the treatment of insufficiently controlled T2DM as an adjunct to diet and exercise.Forxiga.should not be initiated in patients with a glomerular filtration rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min.Forxiga.has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease and is not indicated to reduce the risk of CV events, heart failure or death.3
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is the largest CV outcomes trial conducted for a selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) to date in a broad patient population. It is an AstraZeneca-sponsored, Phase III, randomised, double-blinded, placebo-controlled, multicentre trial, designed to evaluate the effect ofForxiga.compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease and also assessed key renal secondary endpoints. The trial included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, US) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).
完整的结果宣布 - Timi 58审判出版了The New England Journal of Medicine2019年1月。
关于Dapacare临床计划
欧洲杯微信买球AstraZeneca通过解决与心血管（CV），代谢和肾病相关的潜在发病率，死亡率和器官损伤来为疾病管理进行整体，以患者为中心的疾病管理方法。由于这些疾病的互连，Astrazeneca开发了Dapacare临床计划，探讨了CV和肾功能欧洲杯微信买球Forxiga.没有2型糖尿病的人。临床计划将在随机临床试验中注册近30,000名患者，并由跨国现实世界的证据研究支持。Dapacare将产生跨越患有CV病，CV危险因素和肾病的不同阶段的人产生数据，无论是2型糖尿病，还提供有迹象的医疗保健提供者，以改善患者结果。Forxiga.除了在DAPA-CKD试验中的慢性肾病外，还针对慢性心力衰竭患者开发的慢性心力衰竭患者，除了慢性肾脏疾病。Dapacare通过追求整体患者方法来解决与CV，肾病和代谢疾病相关的多种风险因素来遵循科学的承诺。
AboutForxiga.
Forxiga.是一类阶级，口服一次每日SGLT2抑制剂，称为单药治疗，作为组合治疗的一部分，以治疗2型糖尿病的不充分控制的2型糖尿病，具有减肥和血压减少的额外益处，作为辅助用T2D饮食和锻炼成年人。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 patients, as well as more than 2.5 million patient-years’ experience.
About AstraZeneca in CVRM
心血管，肾和新陈代谢（CVRM）一起形成Astrazeneca的三个治疗领域之一，是该公司的主要增长司机。欧洲杯微信买球通过遵循科学更清楚地了解心脏，肾脏和胰腺之间的潜在联系，AstraZeneca正在投资一种药物组合，以保护器官，通过减缓疾病进展，减少风险和解决合并症的改善结果。欧洲杯微信买球该公司的雄心是通过继续提供转型性科学来修改或停止CVRM疾病的自然过程，潜在的再生器官和恢复功能，以改善全世界数百万患者的治疗方法和心血管健康。
About AstraZeneca
AstraZeneca is a global, 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 - Oncology, CVRM, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visitastrazeneca.comand follow us on Twitter@AstraZeneca.
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参考
1. Zelniker Ta，Raz I，Mosenzon O. Dapagliflozin对2型糖尿病患者心血管结果的影响，根据基线肾功能和血红蛋白地位：宣布 - Timi 58的见解[展示：欧洲心脏病学会（Esc）国会2019年，8月31日至9月4日，巴黎，法国。]。
2. koye dn等。糖尿病和肾病的全局流行病学。adv慢性肾脏二2018年;25（2）：121-32。
3.欧洲药物局。产品特征摘要：Forxiga;2012年可从中获取：URL：https://www.ema.europa.eu/en/documents/product-information/forxiga-per-product-in.pdf。