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

CAROLINA®<\/sup>（使用利格列汀對比格列美脲治療2型糖尿病患者的心血管結局研究）是一項多國、隨機、雙盲、活性對照臨床試驗，入組來自43個國家600多個試驗中心的6033名成人2型糖尿病患者，研究觀察的中位持續時間超過6年。[3],[4]<\/sup>試驗入組了早期成人2型糖尿病患者。這些成人患者病程的中位時間為6.2年，其中一些從未接受過任何治療，另一些接受過1-2種降糖藥物 （例如二甲雙胍）。[4]<\/sup>試驗旨在評估利格列汀（每日一次\/5毫克）對比磺脲類格列美脲（均添加于穩定的背景降糖藥物與心血管標準治療之上）對具有高心血管風險或已確診心血管疾病的成人2型糖尿病患者的心血管安全性影響。[3],[4]<\/sup>這些患者均為醫生日常臨床實踐中常見的患者。[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>試驗由學術試驗指導委員會以及由勃林格殷格翰和禮來組成的糖尿病聯盟共同發起。CAROLINA®<\/sup>試驗是目前首個活性藥物對照DPP-4抑制劑心血管結局試驗。<\/p> \n

關于利格列汀<\/b><\/p> \n

利格列汀是一種單一劑量、每日服用一次的DPP4抑制劑，能顯著降低成人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，無論年齡、病程、種族、體重指數（BMI）和肝腎功能如何。[2]<\/sup>在目前上市的DPP4抑制劑中，利格列汀的經腎臟排泄率最低。[6]-[9]<\/sup><\/p> \n

關于我們的心血管結局試驗<\/b><\/p> \n

由于心血管疾病是2型糖尿病的主要并發癥和首要死亡原因，因此心血管結局試驗是非常重要的。在全球范圍內，大多數2型糖尿病患者死于心血管事件。[10]<\/sup> 2015年，勃林格殷格翰和禮來共同宣布了標志性心血管結局試驗EMPA-REG OUTCOME®<\/sup>的研究結果，試驗的研究對象為鈉-葡萄糖協同轉運蛋白2（SGLT2）抑制劑恩格列凈。在標準治療方法上添加恩格列凈，能夠將合并心血管疾病的2型糖尿病成人患者心血管死亡相對風險降低38%。[?][?][11]-[13] <\/sup>因此，恩格列凈在許多國家成為了首個擁有心血管適應癥或在說明書中標明降低心血管死亡風險數據的口服2型糖尿病藥物。[11],[12]<\/sup><\/p> \n

CARMELINA®<\/sup>試驗是一項多國、隨機、雙盲、安慰劑對照的臨床試驗，入組來自27個國家600多個試驗中心的6979名成人2型糖尿病患者，中位觀察時間為2.2年。[14],[15] <\/sup>該研究旨在評估利格列汀對于合并心血管高風險（和\/或腎臟疾病）的成人2型糖尿病患者的心血管和腎臟安全性影響。[14],[15] <\/sup>試驗主要終點達成，[§]<\/sup>在標準治療基礎上，聯用利格列汀展示出與安慰劑相似的心血管安全性。[14]<\/sup> CARMELINA®<\/sup>試驗同時包括了一項關鍵次要復合終點，[**]<\/sup>展示出與安慰劑相似的腎臟安全性。[14]<\/sup> 在CARMELINA®<\/sup>試驗中，利格列汀的總體安全性與既往數據保持一致，沒有發現新的安全性信號。[2],[14]<\/sup> CARMELINA®<\/sup>試驗結果同樣顯示，利格列汀組與安慰劑組在因心衰住院率方面并無差異。[14]<\/sup><\/p> \n

如需了解關于CAROLINA®<\/sup> 和CARMELINA®<\/sup>試驗的更多信息，敬請訪問https:\/\/www.carmelinatrial.com\/<\/a><\/p> \n

勃林格殷格翰公司和禮來制藥<\/b><\/p> \n

2011年1月，勃林格殷格翰公司和禮來制藥宣布在糖尿病治療領域達成合作協議，合作內容包括數類降糖藥物的多個品種。這項合作整合了兩大全球領先的制藥公司的實力。通過攜手合作，兩家公司承諾致力于幫助糖尿病患者，并專注于患者的臨床需求。基于不同的市場，雙方將選擇共同推廣或單獨推廣各自為此項合作所提供的藥物。<\/p> \n

參考文獻<\/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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久久久亚洲欧洲日产国码二区

[?]<\/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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