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關于<\/b>CARMELINA<\/b>®<\/sup><\/b><\/p> \n CARMELINA®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多個試驗點的6979名成人2型糖尿病患者,研究觀察的中位時間為2.2年。[4,5]該研究旨在評估利格列汀(5 mg,每日一次)與安慰劑(均添加于標準治療方法之上)對于高血管風險的2型糖尿病患者心血管結局的影響,其中大多數患者同時患有腎臟疾病。[4,5] 該患者群為醫生日常行醫時常見的具有高心血管和\/或腎病風險的患者。[6] 標準治療方法包括降糖藥物和心血管藥物(包括抗高血壓藥和降脂藥)等。<\/p> \n CARMELINA®<\/sup> <\/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。與其他針對2型糖尿病患者的二肽基肽酶-4(DPP-4)抑制劑近期發布的結局試驗相比,CARMELINA試驗納入的腎功能受損患者比例最大。[7]*<\/sup>[*]<\/p> \n 了解更多關于CARMELINA®<\/sup>的信息,請訪問:https:\/\/www.carmelinatrial.com\/<\/a> <\/p> \n 關于歐唐寧<\/b>®<\/sup><\/b>(利格列汀)<\/b><\/p> \n 歐唐寧®<\/sup>是一種單次給藥、每日一次DPP-4抑制劑,能夠有效降低成人2型糖尿病患者的血糖水平。可為成人2型糖尿病患者使用歐唐寧,而無需考慮其年齡、病程、種族、體重指數(BMI)、肝功能和腎功能。[8] 在目前全球上市的DPP-4抑制劑中,歐唐寧的經腎臟排泄比例最低。[9-12]<\/p> \n 利格列汀由勃林格殷格翰和禮來聯盟研發和商業化。<\/p> \n 關于我<\/b>們<\/b>的心血管<\/b>結<\/b>局<\/b>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具有高度的相關性。在全球范圍內,大多數2型糖尿病患者死于心血管事件。[13] 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®的研究結果,該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。在標準治療方法之上使用恩格列凈,在確診患者心血管疾病的2型糖尿病成人患者中,心血管死亡的相對風險下降了38%。[?][?][14–16]在很多國家的說明書中,恩格列凈是首個具有心血管適應癥或具有心血管死亡風險降低數據的口服2型糖尿病藥物。[14,15]<\/p> \n CAROLINA®<\/sup>是DPP-4抑制劑利格列汀的兩項心血管結局試驗之一。[17,18] CAROLINA®<\/sup> 和使用利格列汀治療具有高血管風險的2型糖尿病患者的血管安全與腎臟微血管結局試驗(CARMELINA®<\/sup>)[4,5]提供了關于DPP-4抑制劑長期安全性的最全面的數據集。<\/p> \n CARMELINA®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多個試驗點的6979名成人2型糖尿病患者,研究觀察的中位時間為2.2年。[4,5] CARMELINA®<\/sup>研究了歐唐寧(利格列汀)對高心血管疾病和\/或高腎臟疾病風險2型糖尿病患者的心血管和腎臟安全性的影響。[4,5] 該試驗達到了主要終點,[§]與安慰劑相比,在標準治療方法之上添加利格列汀顯示出了相似的心血管安全性特征。[5] CARMELINA®<\/sup>還納入了一個次要復合終點,[**]與安慰劑相比顯示出了相似的腎臟安全性特征。[5] CARMELINA®<\/sup>中利格列汀的總體安全性特征與此前的數據一致,且未觀察到新的安全性信號。[5,6] CARMELINA®<\/sup>還表明,接受利格列汀治療的患者因心力衰竭住院的比率與安慰劑相似。[5]<\/p> \n 了解更多關于CAROLINA®<\/sup> <\/sup>和CARMELINA®<\/sup>的信息,請訪問:https:\/\/www.carmelinatrial.com\/<\/a>。<\/p> \n 關于勃林格殷格翰<\/b><\/p> \n 研發驅動的制藥公司勃林格殷格翰始終致力于改善人類與動物的健康,專注于探索尚未出現有效治療方案的疾病領域。公司著力開發創新療法,幫助患者延長生命。在動物保健領域,勃林格殷格翰代表著先進的預防方案。<\/p> \n 勃林格殷格翰成立于1885年,至今仍是家族企業。公司是全球前20大制藥企業之一。在人用藥品、動物保健和生物制藥合同生產三個業務領域,全球約5萬名員工每天都在努力通過創新展現價值。2018年,勃林格殷格翰公司實現凈銷售額約175億歐元;研發支出近32億歐元,相當于凈銷售額的18.1%。<\/p> \n 作為一家家族企業,勃林格殷格翰志存高遠并致力于獲得長期的成功。公司旨在通過自身資源實現有機增長,同時積極尋求研發領域的合作伙伴與戰略聯盟。此外,公司的一切行為都對人類和環境負責。<\/p> \n 請點擊公司官方網站www.boehringer-ingelheim.com<\/a>或年報http:\/\/annualreport.boehringer-ingelheim.com<\/a> 了解更多關于勃林格殷格翰的信息。<\/p> \n 目標讀者<\/b><\/p> \n 本新聞稿由位于德國殷格翰的勃林格殷格翰公司總部發布,旨在提供全球業務信息。請注意,由于獲批產品的批準狀態和說明書的相關信息可能因國家而異,勃林格殷格翰公司和禮來公司開展業務的國家可能已經發布了針對該主題的新聞稿。<\/p> \n 腳注:<\/span><\/b><\/p> \n ‘*腎小球濾過率低于60 mL\/min\/1.73 m<\/span>2<\/sup><\/p> \n ?<\/sup>患有冠狀動脈疾病、外周動脈疾病或有MI或卒中病史的2型糖尿病成年患者<\/p> \n ?<\/sup>標準治療包括醫生決定開處的心血管藥物和降糖藥物<\/p> \n §<\/sup>主要終點定義為至首次發生3P-MACE(心血管死亡、非致死性心肌梗塞或非致死性卒中)的時間<\/p> \n **次要終點定義為至首次發生持續的終末期腎臟病(ESKD)、腎病引起的死亡或與安慰劑相比eGFR自基線≥40%持續降低的時間<\/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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