Marx Nikolaus, Rosenstock Julio, Kahn Steven E, Zinman Bernard, Kastelein John J, Lachin John M, Espeland Mark A, Bluhmki Erich, Mattheus Michaela, Ryckaert Bart, Patel Sanjay, Johansen Odd Erik, Woerle Hans-Juergen
Department of Internal Medicine I, University Hospital Aachen, Aachen, Germany
Dallas Diabetes and Endocrine Center at Medical City and University of Texas, Southwestern Medical Center, Dallas, TX, USA.
Diab Vasc Dis Res. 2015 May;12(3):164-74. doi: 10.1177/1479164115570301. Epub 2015 Mar 15.
CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (NCT01243424) is an ongoing, randomized trial in subjects with early type 2 diabetes and increased cardiovascular risk or established complications that will determine the long-term cardiovascular impact of linagliptin versus the sulphonylurea glimepiride. Eligible patients were sulphonylurea-naïve with HbA1c 6.5%-8.5% or previously exposed to sulphonylurea (in monotherapy or in a combination regimen <5 years) with HbA1c 6.5%-7.5%. Primary outcome is time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina. A total of 631 patients with primary outcome events will be required to provide 91% power to demonstrate non-inferiority in cardiovascular safety by comparing the upper limit of the two-sided 95% confidence interval as being below 1.3 for a given hazard ratio. Hierarchical testing for superiority will follow, and the trial has 80% power to demonstrate a 20% relative cardiovascular risk reduction. A total of 6041 patients were treated with median type 2 diabetes duration 6.2 years, 40.0% female, mean HbA1c 7.2%, 66% on 1 and 24% on 2 glucose-lowering agents and 34.5% had previous cardiovascular complications. The results of CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes may influence the decision-making process for selecting a second glucose-lowering agent after metformin in type 2 diabetes.
利格列汀与格列美脲治疗2型糖尿病的心血管结局试验（NCT01243424）是一项正在进行的随机试验，研究对象为早期2型糖尿病且心血管风险增加或已出现并发症的患者，该试验将确定利格列汀与磺脲类药物格列美脲对心血管的长期影响。符合条件的患者为未使用过磺脲类药物且糖化血红蛋白（HbA1c）为6.5%-8.5%的患者，或之前使用过磺脲类药物（单药治疗或联合治疗<5年）且HbA1c为6.5%-7.5%的患者。主要结局是首次发生心血管死亡、非致死性心肌梗死、非致死性卒中或因不稳定型心绞痛住院的时间。总共需要631例发生主要结局事件的患者，通过比较双侧95%置信区间的上限在给定风险比下低于1.3，以提供91%的检验效能来证明心血管安全性的非劣效性。随后将进行优效性的分层检验，该试验有80%的检验效能来证明心血管相对风险降低20%。共有6041例患者接受治疗，2型糖尿病中位病程为6.2年，女性占40.0%，平均HbA1c为7.2%，66%的患者使用1种降糖药物，24%的患者使用2种降糖药物，34.5%的患者既往有心血管并发症。利格列汀与格列美脲治疗2型糖尿病的心血管结局试验结果可能会影响2型糖尿病患者在二甲双胍之后选择第二种降糖药物的决策过程。
