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关于<\/b>CARMELINA<\/b>®<\/sup><\/b><\/p> \n CARMELINA®试验是一项多国、随机、双盲、安慰剂对照的临床试验,入组来自27个国家600多个试验点的6979名成人2型糖尿病患者,研究观察的中位时间为2.2年。[4,5]该研究旨在评估利格列汀(5 mg,每日一次)与安慰剂(均添加于标准治疗方法之上)对于高血管风险的2型糖尿病患者心血管结局的影响,其中大多数患者同时患有肾脏疾病。[4,5] 该患者群为医生日常行医时常见的具有高心血管和\/或肾病风险的患者。[6] 标准治疗方法包括降糖药物和心血管药物(包括抗高血压药和降脂药)等。<\/p> \n CARMELINA®<\/sup> <\/sup>试验由学术试验指导委员会以及由勃林格殷格翰和礼来组成的糖尿病联盟共同发起。与其他针对2型糖尿病患者的二肽基肽酶-4(DPP-4)抑制剂近期发布的结局试验相比,CARMELINA试验纳入的肾功能受损患者比例最大。[7]*<\/sup>[*]<\/p> \n 了解更多关于CARMELINA®<\/sup>的信息,请访问:https:\/\/www.carmelinatrial.com\/<\/a> <\/p> \n 关于欧唐宁<\/b>®<\/sup><\/b>(利格列汀)<\/b><\/p> \n 欧唐宁®<\/sup>是一种单次给药、每日一次DPP-4抑制剂,能够有效降低成人2型糖尿病患者的血糖水平。可为成人2型糖尿病患者使用欧唐宁,而无需考虑其年龄、病程、种族、体重指数(BMI)、肝功能和肾功能。[8] 在目前全球上市的DPP-4抑制剂中,欧唐宁的经肾脏排泄比例最低。[9-12]<\/p> \n 利格列汀由勃林格殷格翰和礼来联盟研发和商业化。<\/p> \n 关于我<\/b>们<\/b>的心血管<\/b>结<\/b>局<\/b>试验<\/b><\/p> \n 由于心血管疾病是2型糖尿病的主要并发症和首要死亡原因,因此心血管结局试验具有高度的相关性。在全球范围内,大多数2型糖尿病患者死于心血管事件。[13] 2015年,勃林格殷格翰和礼来共同宣布了标志性心血管结局试验EMPA-REG OUTCOME®的研究结果,该试验的研究对象为钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂恩格列净。在标准治疗方法之上使用恩格列净,在确诊患者心血管疾病的2型糖尿病成人患者中,心血管死亡的相对风险下降了38%。[†][‡][14–16]在很多国家的说明书中,恩格列净是首个具有心血管适应症或具有心血管死亡风险降低数据的口服2型糖尿病药物。[14,15]<\/p> \n CAROLINA®<\/sup>是DPP-4抑制剂利格列汀的两项心血管结局试验之一。[17,18] CAROLINA®<\/sup> 和使用利格列汀治疗具有高血管风险的2型糖尿病患者的血管安全与肾脏微血管结局试验(CARMELINA®<\/sup>)[4,5]提供了关于DPP-4抑制剂长期安全性的最全面的数据集。<\/p> \n CARMELINA®是一项多国、随机、双盲、安慰剂对照的临床试验,入组来自27个国家600多个试验点的6979名成人2型糖尿病患者,研究观察的中位时间为2.2年。[4,5] CARMELINA®<\/sup>研究了欧唐宁(利格列汀)对高心血管疾病和\/或高肾脏疾病风险2型糖尿病患者的心血管和肾脏安全性的影响。[4,5] 该试验达到了主要终点,[§]与安慰剂相比,在标准治疗方法之上添加利格列汀显示出了相似的心血管安全性特征。[5] CARMELINA®<\/sup>还纳入了一个次要复合终点,[**]与安慰剂相比显示出了相似的肾脏安全性特征。[5] CARMELINA®<\/sup>中利格列汀的总体安全性特征与此前的数据一致,且未观察到新的安全性信号。[5,6] CARMELINA®<\/sup>还表明,接受利格列汀治疗的患者因心力衰竭住院的比率与安慰剂相似。[5]<\/p> \n 了解更多关于CAROLINA®<\/sup> <\/sup>和CARMELINA®<\/sup>的信息,请访问:https:\/\/www.carmelinatrial.com\/<\/a>。<\/p> \n 关于勃林格殷格翰<\/b><\/p> \n 研发驱动的制药公司勃林格殷格翰始终致力于改善人类与动物的健康,专注于探索尚未出现有效治疗方案的疾病领域。公司着力开发创新疗法,帮助患者延长生命。在动物保健领域,勃林格殷格翰代表着先进的预防方案。<\/p> \n 勃林格殷格翰成立于1885年,至今仍是家族企业。公司是全球前20大制药企业之一。在人用药品、动物保健和生物制药合同生产三个业务领域,全球约5万名员工每天都在努力通过创新展现价值。2018年,勃林格殷格翰公司实现净销售额约175亿欧元;研发支出近32亿欧元,相当于净销售额的18.1%。<\/p> \n 作为一家家族企业,勃林格殷格翰志存高远并致力于获得长期的成功。公司旨在通过自身资源实现有机增长,同时积极寻求研发领域的合作伙伴与战略联盟。此外,公司的一切行为都对人类和环境负责。<\/p> \n 请点击公司官方网站www.boehringer-ingelheim.com<\/a>或年报http:\/\/annualreport.boehringer-ingelheim.com<\/a> 了解更多关于勃林格殷格翰的信息。<\/p> \n 目标读者<\/b><\/p> \n 本新闻稿由位于德国殷格翰的勃林格殷格翰公司总部发布,旨在提供全球业务信息。请注意,由于获批产品的批准状态和说明书的相关信息可能因国家而异,勃林格殷格翰公司和礼来公司开展业务的国家可能已经发布了针对该主题的新闻稿。<\/p> \n 脚注:<\/span><\/b><\/p> \n ‘*肾小球滤过率低于60 mL\/min\/1.73 m<\/span>2<\/sup><\/p> \n †<\/sup>患有冠状动脉疾病、外周动脉疾病或有MI或卒中病史的2型糖尿病成年患者<\/p> \n ‡<\/sup>标准治疗包括医生决定开处的心血管药物和降糖药物<\/p> \n §<\/sup>主要终点定义为至首次发生3P-MACE(心血管死亡、非致死性心肌梗塞或非致死性卒中)的时间<\/p> \n **次要终点定义为至首次发生持续的终末期肾脏病(ESKD)、肾病引起的死亡或与安慰剂相比eGFR自基线≥40%持续降低的时间<\/p> \n REFERENCES:<\/b><\/p> \n 1. Cooper M, Rosenstock J, Kadowaki T, et al<\/i>. Cardiovascular and kidney outcomes of linagliptin treatment in older people with type 2 diabetes and established cardiovascular disease and\/or kidney disease: A prespecified subgroup analysis of the randomized, placebo-controlled CARMELINA®<\/sup> trial. Diabetes Obes Metab<\/i>. 2020; doi: 10.1111\/dom.13995. <\/p> \n 2. IDF Diabetes Atlas, 9th edition. Brussels, Belgium<\/span>: International Diabetes Federation; 2019. Available at: www.diabetesatlas.org\/<\/a>. Accessed: January 2020<\/span>.<\/p> \n 3. Lakey WC, Barnard K, Batch BC, et al<\/i>. Are current clinical trials in diabetes addressing important issues in diabetes care? Diabetologia<\/i>. 2013;56:1226–35.<\/p> \n 4. ClinicalTrials.Gov. Cardiovascular and renal microvascular outcome study with linagliptin in patients with type 2 diabetes mellitus (CARMELINA). Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01897532?term=NCT01897532&rank=1<\/a>. Accessed: January 2020<\/span>.<\/p> \n 5. Rosenstock J, Perkovic V, Johansen O, et al<\/i>. Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk: The CARMELINA Randomized Clinical Trial. JAMA<\/i>. 2019;321<\/b>(1):69–79.<\/p> \n 6. Boehringer Ingelheim and Eli Lilly and Company. Data on file.<\/p> \n 7. Rosenstock J, Perkovic V, Alexander JH, et al<\/i>. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®<\/sup>): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk. Cardiovasc Diabetol<\/i>. 2018;17<\/b>(1):39.<\/p> \n 8. European Medicines Agency. Trajenta®<\/sup> (linagliptin) tablets. EMA Summary of Product Characteristics. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002110\/WC500115745.pdf<\/a>. Last updated December 2019<\/span>. Accessed: January 2020<\/span>.<\/p> \n 9. European Medicines Agency. Onglyza®<\/sup> (saxagliptin) tablets. EMA Summary of Product Characteristics. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/001039\/WC500044316.pdf<\/a>. Last updated: November 2018<\/span>. Accessed: January 2020<\/span>.<\/p> \n 10. European Medicines Agency. Vipidia®<\/sup> (alogliptin) tablets. EMA Summary of Product Characteristics. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002182\/WC500152271.pdf<\/a>. Last updated: December 2018<\/span>. Accessed: January 2020<\/span>.<\/p> \n 11. European Medicines Agency. Januvia®<\/sup> (sitagliptin) tablets. EMA Summary of Product Characteristics. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000722\/WC500039054.pdf<\/a>. Last updated: April 2019<\/span>. Accessed: January 2020<\/span>.<\/p> \n 12. European Medicines Agency. Galvus®<\/sup> (vildagliptin) tablets. EMA Summary of Product Characteristics. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000771\/WC500020327.pdf<\/a>. Last updated: May 2018<\/span>. Accessed: January 2020<\/span>.<\/p> \n 13. World Heart Federation. Cardiovascular Disease Risk Factors. Available at: https:\/\/www.world-heart-federation.org\/resources\/risk-factors\/<\/a>. Accessed: January 2020<\/span>.<\/p> \n 14. Jardiance®<\/sup> (empagliflozin) tablets U.S. Prescribing Information. FDA. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/204629s008lbl.pdf<\/a>. Last updated: December 2016<\/span>. Accessed: January 2020<\/span>.<\/p> \n 15. Jardiance®<\/sup> (empagliflozin) EMA Summary of Product Characteristics. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002677\/WC500168592.pdf<\/a>. Last updated: January 2020<\/span>. Accessed: January 2020<\/span>.<\/p> \n 16. Zinman B, Wanner C, Lachin JM, et al<\/i>. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med<\/i>. 2015;373<\/b>(22):2117–28.<\/p> \n 17. ClinicalTrials.Gov. CAROLINA: Cardiovascular outcome study of linagliptin versus glimepiride in patients with type 2 diabetes. Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01243424<\/a>. Accessed: January 2020<\/span>.<\/p> \n 18. Marx N, Rosenstock J, Kahn S, et al<\/i>. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®<\/sup>). Diab Vasc Dis Res<\/i>. 2015;12<\/b>(3):164–74.<\/p> \n <\/p>"];
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