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关于<\/b> <\/b>CAROLINA®<\/sup><\/b>研究<\/b><\/p> \n

CAROLINA®<\/sup>（使用利格列汀对比格列美脲治疗2型糖尿病患者的心血管结局研究）是一项多国、随机、双盲、活性对照临床试验，入组来自43个国家600多个试验中心的6033名成人2型糖尿病患者，研究观察的中位持续时间超过6年。[3],[4]<\/sup>试验入组了早期成人2型糖尿病患者。这些成人患者病程的中位时间为6.2年，其中一些从未接受过任何治疗，另一些接受过1-2种降糖药物 （例如二甲双胍）。[4]<\/sup>试验旨在评估利格列汀（每日一次\/5毫克）对比磺脲类格列美脲（均添加于稳定的背景降糖药物与心血管标准治疗之上）对具有高心血管风险或已确诊心血管疾病的成人2型糖尿病患者的心血管安全性影响。[3],[4]<\/sup>这些患者均为医生日常临床实践中常见的患者。[5]<\/sup><\/p> \n

CAROLINA®<\/sup> was led by an academic trial steering committee and Boehringer Ingelheim and Eli Lilly and Company. CAROLINA®<\/sup> is the only DPP-4 inhibitor, active-comparator cardiovascular outcome trial.<\/p> \n

CAROLINA®<\/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。CAROLINA®<\/sup>试验是目前首个活性药物对照DPP-4抑制剂心血管结局试验。<\/p> \n

关于利格列汀<\/b><\/p> \n

利格列汀是一种单一剂量、每日服用一次的DPP4抑制剂，能显著降低成人2型糖尿病患者的血糖水平。成人2型糖尿病患者均可使用，无论年龄、病程、种族、体重指数（BMI）和肝肾功能如何。[2]<\/sup>在目前上市的DPP4抑制剂中，利格列汀的经肾脏排泄率最低。[6]-[9]<\/sup><\/p> \n

关于我们的心血管结局试验<\/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是非常重要的。在全球范围内，大多数2型糖尿病患者死于心血管事件。[10]<\/sup> 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®<\/sup>的研究结果，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。在标准治疗方法上添加恩格列净，能够将合并心血管疾病的2型糖尿病成人患者心血管死亡相对风险降低38%。[†][‡][11]-[13] <\/sup>因此，恩格列净在许多国家成为了首个拥有心血管适应症或在说明书中标明降低心血管死亡风险数据的口服2型糖尿病药物。[11],[12]<\/sup><\/p> \n

CARMELINA®<\/sup>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多个试验中心的6979名成人2型糖尿病患者，中位观察时间为2.2年。[14],[15] <\/sup>该研究旨在评估利格列汀对于合并心血管高风险（和\/或肾脏疾病）的成人2型糖尿病患者的心血管和肾脏安全性影响。[14],[15] <\/sup>试验主要终点达成，[§]<\/sup>在标准治疗基础上，联用利格列汀展示出与安慰剂相似的心血管安全性。[14]<\/sup> CARMELINA®<\/sup>试验同时包括了一项关键次要复合终点，[**]<\/sup>展示出与安慰剂相似的肾脏安全性。[14]<\/sup> 在CARMELINA®<\/sup>试验中，利格列汀的总体安全性与既往数据保持一致，没有发现新的安全性信号。[2],[14]<\/sup> CARMELINA®<\/sup>试验结果同样显示，利格列汀组与安慰剂组在因心衰住院率方面并无差异。[14]<\/sup><\/p> \n

如需了解关于CAROLINA®<\/sup> 和CARMELINA®<\/sup>试验的更多信息，敬请访问https:\/\/www.carmelinatrial.com\/<\/a><\/p> \n

勃林格殷格翰公司和礼来制药<\/b><\/p> \n

2011年1月，勃林格殷格翰公司和礼来制药宣布在糖尿病治疗领域达成合作协议，合作内容包括数类降糖药物的多个品种。这项合作整合了两大全球领先的制药公司的实力。通过携手合作，两家公司承诺致力于帮助糖尿病患者，并专注于患者的临床需求。基于不同的市场，双方将选择共同推广或单独推广各自为此项合作所提供的药物。<\/p> \n

参考文献<\/b>:<\/b><\/p> \n

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[3].<\/sup>      ClinicalTrials.Gov. CARdiovascular Outcome study of LINAgliptin versus Glimepiride in patients with Type 2 diabetes. Available from: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01243424<\/a>. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[4].<\/sup>      Marx N, 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.<\/span><\/p> <\/td> \n <\/tr> \n

[5].<\/sup>      Boehringer Ingelheim and Eli Lilly and Company. Patients and clinical practice. Data on file.<\/span><\/p> <\/td> \n <\/tr> \n

[6].<\/sup>      European Medicines Agency. Onglyza®<\/sup> (saxagliptin) tablets. EMA Summary of Product Characteristics. Available from: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/001039\/WC500044316.pdf<\/a>. Last updated: July 2016. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[7].<\/sup>      European Medicines Agency. Vipidia®<\/sup> (alogliptin) tablets. EMA Summary of Product Characteristics. Available from: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002182\/WC500152271.pdf<\/a>. Last updated: January 2015. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[8].<\/sup>      European Medicines Agency. Januvia®<\/sup> (sitagliptin) tablets. EMA Summary of Product Characteristics. Available from: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000722\/WC500039054.pdf<\/a>. Last updated: August 2017. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[9].<\/sup>      European Medicines Agency. Galvus®<\/sup> (vildagliptin) tablets. EMA Summary of Product Characteristics. Available from: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000771\/WC500020327.pdf<\/a>. Last updated: June 2017. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[10].<\/sup>    World Heart Federation. Cardiovascular Disease Risk Factors. Available from: https:\/\/www.world-heart-federation.org\/resources\/risk-factors\/<\/a>. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[11].<\/sup>    Jardiance®<\/sup> (empagliflozin) tablets U.S. Prescribing Information. FDA. Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/204629s008lbl.pdf<\/a>. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[12].<\/sup>    Jardiance®<\/sup> (empagliflozin) EMA Summary of Product Characteristics. Available from: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002677\/WC500168592.pdf<\/a>. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n

[13].<\/sup>    Zinman B, et al.<\/i> Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med<\/i>. 2015;373<\/b>(22):2117-28.<\/span><\/p> <\/td> \n <\/tr> \n

[14].<\/sup>    Rosenstock J, 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®<\/sup> Randomized Clinical Trial. JAMA<\/i>. 2019;321<\/b>(1):69-79.<\/span><\/p> <\/td> \n <\/tr> \n

[15].<\/sup>    ClinicalTrials.Gov. Cardiovascular and renal microvascular outcome study with linagliptin in patients with type 2 diabetes mellitus at high vascular risk. Available from: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01897532?term=NCT01897532&rank=1<\/a>. Accessed: June 2019.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n

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[†]<\/sup> Adult patients with type 2 diabetes and coronary artery disease, peripheral artery disease, or a history of MI or stroke.<\/span><\/p> <\/td> \n <\/tr> \n

[‡] <\/sup>Standard of care included cardiovascular medications and blood sugar lowering agents given at the discretion of physicians.<\/span><\/p> <\/td> \n <\/tr> \n

[§]<\/sup> Primary endpoint defined as time to first occurrence of the 3P-MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke).<\/span><\/p> <\/td> \n <\/tr> \n

[**]<\/sup> Key secondary endpoint defined as time to first occurrence of sustained end stage kidney disease (ESKD), death due to kidney disease, or a sustained decrease in eGFR from baseline of ≥40 percent compared to placebo.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n

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