CAROLINA^{®<\/sup><\/b>（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、活性藥物對照臨床試驗，入組來自43個國家和地區600多個試驗中心的6033名成人2型糖尿病患者，研究隨訪的中位持續時間超過6年。^{[1],[2]<\/span><\/sup>試驗入組早期成人2型糖尿病患者，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，另一些服用過1-2種降糖藥（例如二甲雙胍）。^{[2]<\/span><\/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（均添加于穩定的基礎降糖藥物與心血管標準治療方法之上）對心血管風險增加或已出現心血管疾病的成人2型糖尿病患者的心血管安全性影響。^{[1],[2]<\/span><\/sup>這些患者反應了醫生日常臨床實踐中常見的患者群。^{^{[6]<\/span><\/sup><\/sup> <\/p> \n}}}}}}

CAROLINA^{®<\/sup><\/b>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><\/b>試驗是首個活性藥物對照的DPP-4抑制劑心血管結局試驗。 <\/p> \n}}

利格列汀是一種無需單劑量調整、每日服用一次的DPP-4抑制劑，能顯著降低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。3在目前上市的DPP-4抑制劑中，利格列汀的腎臟排泄率最低。 ^{[7],[8],[9],[10]<\/span><\/sup><\/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。^{[4]<\/span><\/sup>2015年，勃林格殷格翰和禮來共同宣布了標志性里程碑的EMPA-REGOUTCOME®心血管結局試驗結果，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成人2型糖尿病患者的心血管死亡相對風險降低38%。^{^{[a]<\/sup><\/sup>^{^{[b]<\/sup><\/sup>^{^{[11],<\/sup><\/sup>^{^{[12],<\/sup><\/sup>^{^{[13]<\/sup><\/sup><\/span>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型糖尿病治療藥物。 ^{[11],[12]<\/span><\/sup><\/p> \n}}}}}}}}}}}}

CAROLINA^{®<\/sup><\/b>是DPP-4抑制劑利格列汀的兩項心血管結局試驗之一。^{[1],[2]<\/span><\/sup>CAROLINA^{®<\/sup><\/b>和CARMELINA^{®<\/sup>（<\/b>使用利格列汀治療高血管風險2型糖尿病患者的心血管安全性與腎臟微血管安全性結局試驗）^{[5,][14] <\/span><\/sup>提供了DPP-4抑制劑中齊全面的長期安全性數據之一。<\/p> \n}}}}}

CARMELINA^{®<\/sup><\/b>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，研究觀察的中位時間為2.2年。^{[5,][14]<\/span><\/sup>該研究旨在評估利格列汀對于心血管高風險和\/或并發腎臟疾病的成人2型糖尿病患者的心血管和腎臟安全性影響。^{[5,][14]<\/span><\/sup>該試驗達到主要終點，^{[c]<\/sup><\/span>即在標準治療方法基礎上，聯用利格列汀展示出與安慰劑相似的心血管安全性。^{[5]<\/sup><\/span>CARMELINA^{®<\/sup><\/b>試驗同時包括了一項關鍵次要復合終點，^{[d]<\/sup><\/span>展示出與安慰劑相似的腎臟安全性。^{[5]<\/sup><\/span>在CARMELINA^{®<\/sup><\/b>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。^{[3],[5]<\/span><\/sup>CARMELINA^{®<\/sup><\/b>試驗結果同樣顯示，利格列汀組與安慰劑組在心衰住院率方面并無差異。^{[5]<\/sup><\/span><\/p> \n}}}}}}}}}}}}

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[a] Adult patients with type 2 diabetes and coronary artery disease, peripheral artery disease, or a history of MI or stroke<\/span><\/span><\/p> <\/td> \n <\/tr> \n
[b] Standard of care included cardiovascular medications and blood sugar lowering agents given at the discretion of physicians<\/span><\/span><\/p> <\/td> \n <\/tr> \n
[c] Primary endpoint defined as time to first occurrence of the 3P-MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke)<\/span><\/span><\/p> <\/td> \n <\/tr> \n
[d] 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><\/span><\/p> <\/td> \n <\/tr> \n
[1] ClinicalTrials.Gov. CARdiovascular Outcome study of LINAgliptin versus Glimepiride in patients with Type 2 diabetes. Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01243424<\/a>. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n
[2] Marx N, et al<\/i>. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®). Diabetes & Vascular Disease Research<\/i> 2015;12(3)<\/b>:164-74. <\/span><\/p> <\/td> \n <\/tr> \n
[3] European Medicines Agency. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. Last updated July 2018. Available at: https:\/\/www.ema.europa.eu\/documents\/product-information\/trajenta-epar-product-information_en.pdf<\/a> Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n
[4]^{<\/sup>World Heart Federation. Cardiovascular Disease Risk Factors. Available at: https:\/\/www.world-heart-federation.org\/resources\/risk-factors\/<\/a>. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}
[5] 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>. 2018 Nov 9. doi: 10.1001\/jama.2018.18269.<\/span><\/p> <\/td> \n <\/tr> \n}
[6] Boehringer Ingelheim and Eli Lilly and Company. Data on file.<\/span><\/p> <\/td> \n <\/tr> \n
[7] European Medicines Agency. Onglyza^{®<\/sup> (saxagliptin) tablets. EMA Summary of Product Characteristics. Available from: https:\/\/www.ema.europa.eu\/documents\/product-information\/onglyza-epar-product-information_en.pdf<\/a> Last updated: July 2016. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}
[8] European Medicines Agency. Vipidia^{®<\/sup> (alogliptin) tablets. EMA Summary of Product Characteristics. Available from: http:\/\/ec.europa.eu\/health\/documents\/community-register\/2015\/20150115130399\/anx_130399_en.pdf<\/a> Last updated: January 2015. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}
[9] European Medicines Agency. Januvia^{®<\/sup> (sitagliptin) tablets. EMA Summary of Product Characteristics. Available from: https:\/\/ec.europa.eu\/health\/documents\/community-register\/2018\/20180516140764\/anx_140764_en.pdf<\/a> Last updated: August 2017. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}
[10]^{<\/sup>European Medicines Agency. Galvus^{®<\/sup> (vildagliptin) tablets. EMA Summary of Product Characteristics. Available from: https:\/\/www.ema.europa.eu\/documents\/product-information\/galvus-epar-product-information_en.pdf<\/a> Last updated: June 2017. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}}
[11] Jardiance^{®<\/sup> (empagliflozin) tablets U.S. Prescribing Information. FDA. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/204629s008lbl.pdf<\/a>. Accessed February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}
[12] Jardiance^{®<\/sup> (empagliflozin) Summary of Product Characteristics. EMA. Available at: http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/002677\/WC500168592.pdf<\/a>. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n}
[13] Zinman B, et al<\/i>. EMPA-REG OUTCOME^{®<\/sup> Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med.<\/i> 2015;373<\/b>(22)<\/b>:2117-2128.<\/span><\/p> <\/td> \n <\/tr> \n}
[14] ClinicalTrials.Gov. Cardiovascular and renal microvascular outcome study with linagliptin in patients with type 2 diabetes mellitus at high vascular risk. Available at: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01897532?term=NCT01897532&rank=1<\/a>. Accessed: February 2019.<\/span><\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div> \n
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