Itzhaki Ben Zadok O, Eisen A
Department of Cardiology, Rabin Medical Center, Petah Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Diabet Med. 2018 May;35(5):548-556. doi: 10.1111/dme.13600. Epub 2018 Mar 4.
To examine the efficacy and safety of non-vitamin K oral anticoagulants in people with both atrial fibrillation and diabetes mellitus.
We reviewed efficacy and safety data from the warfarin-controlled phase III non-vitamin K oral anticoagulants trials (ARISTOTLE, RE-LY, ROCKET-AF, ENGAGE AF-TIMI 48) and their post hoc analyses with regard to diabetes status. We also reviewed the updated literature regarding this population.
At baseline 20-40% of the participants in the phase III non-vitamin K oral anticoagulants trials had diabetes mellitus at baseline. This population, in comparison with those without diabetes, was more likely to have other comorbidities, such as hypertension and coronary artery disease; thus, their cardiovascular risk was higher. Participants with diabetes had higher rates of stroke and systemic embolism than participants without diabetes. This risk was decreased using non-vitamin K oral anticoagulants, with no significant interaction by diabetic status or the specific drug used. Overall, compared with warfarin, non-vitamin K oral anticoagulants were safe and reduced the incidence of major bleeding in people with atrial fibrillation and diabetes, although the results varied with the different non-vitamin K oral anticoagulants.
The efficacy and safety of non-vitamin K oral anticoagulants compared with warfarin generally extend to participants with diabetes mellitus, although dedicated randomized trials or real-world data are lacking.
探讨非维生素K口服抗凝剂在合并心房颤动和糖尿病患者中的疗效及安全性。
我们回顾了华法林对照的III期非维生素K口服抗凝剂试验(ARISTOTLE、RE-LY、ROCKET-AF、ENGAGE AF-TIMI 48)及其关于糖尿病状态的事后分析中的疗效和安全性数据。我们还回顾了有关该人群的最新文献。
在基线时,III期非维生素K口服抗凝剂试验中20%-40%的参与者患有糖尿病。与无糖尿病者相比,该人群更易合并其他疾病,如高血压和冠状动脉疾病;因此,他们的心血管风险更高。糖尿病患者的中风和全身性栓塞发生率高于无糖尿病者。使用非维生素K口服抗凝剂可降低这种风险,且糖尿病状态或所使用的特定药物之间无显著相互作用。总体而言,与华法林相比,非维生素K口服抗凝剂是安全的,可降低心房颤动合并糖尿病患者的大出血发生率,尽管不同的非维生素K口服抗凝剂结果有所不同。
与华法林相比,非维生素K口服抗凝剂的疗效和安全性通常也适用于糖尿病患者,尽管缺乏专门的随机试验或真实世界数据。