Nelson Winnie W, Desai Sunita, Damaraju Chandrasekharrao V, Lu Lang, Fields Larry E, Wildgoose Peter, Schein Jeffery R
Health Economics and Outcomes Research (HECOR), Janssen Scientific Affairs, LLC, 1000 US Highway 202 South, Raritan, NJ, 08869, USA,
Am J Cardiovasc Drugs. 2015 Jun;15(3):205-11. doi: 10.1007/s40256-015-0120-9.
Maintaining stable levels of anticoagulation using warfarin therapy is challenging. Few studies have examined the stability of the international normalized ratio (INR) in patients with nonvalvular atrial fibrillation (NVAF) who have had ≥6 months' exposure to warfarin anticoagulation for stroke prevention.
Our objective was to describe INR control in NVAF patients who had been receiving warfarin for at least 6 months.
Using retrospective patient data from the CoagClinic™ database, we analyzed data from NVAF patients treated with warfarin to assess the quality of INR control and possible predictors of poor INR control. Time within, above, and below the recommended INR range (2.0-3.0) was calculated for patients who had received warfarin for ≥6 months and had three or more INR values. The analysis also assessed INR patterns and resource utilization of patients with an INR >4.0. Logistic regression models were used to determine factors associated with poor INR control.
Patients (n = 9433) had an average of 1.6 measurements per 30 days. Mean follow-up time was 544 days. Approximately 39% of INR values were out of range, with 23% of INR values being <2.0 and 16% being >3.0. Mean percent time with INR in therapeutic range was 67%; INR <2.0 was 19% and INR >3.0 was 14%. Patients with more than one reading of INR >4.0 (~39%) required an average of one more visit and took 3 weeks to return to an in-range INR. Male sex and age >75 years were predictive of better INR control, whereas a history of heart failure or diabetes were predictive of out-of-range INR values. However, patient characteristics did not predict the likelihood of INR >4.0.
Out-of-range INR values remain frequent in patients with NVAF treated with warfarin. Exposure to high INR values was common, resulting in increased resource utilization.
使用华法林治疗维持稳定的抗凝水平具有挑战性。很少有研究探讨非瓣膜性心房颤动（NVAF）患者在接受华法林抗凝预防卒中≥6个月时国际标准化比值（INR）的稳定性。
我们的目的是描述接受华法林治疗至少6个月的NVAF患者的INR控制情况。
利用CoagClinic™数据库中的回顾性患者数据，我们分析了接受华法林治疗的NVAF患者的数据，以评估INR控制的质量以及INR控制不佳的可能预测因素。对于接受华法林治疗≥6个月且有三个或更多INR值的患者，计算其在推荐INR范围（2.0 - 3.0）内、之上和之下的时间。该分析还评估了INR>4.0的患者的INR模式和资源利用情况。使用逻辑回归模型确定与INR控制不佳相关的因素。
患者（n = 9433）平均每30天进行1.6次测量。平均随访时间为544天。约39%的INR值超出范围，其中23%的INR值<2.0，16%的INR值>3.0。INR处于治疗范围内的平均时间百分比为67%；INR<2.0为19%，INR>3.0为14%。INR>4.0的读数超过一次的患者（约39%）平均需要多就诊一次，且需要3周时间才能使INR恢复到范围内。男性和年龄>75岁预示着更好的INR控制，而心力衰竭或糖尿病病史则预示着INR值超出范围。然而，患者特征并不能预测INR>4.0的可能性。
在接受华法林治疗的NVAF患者中，INR值超出范围的情况仍然很常见。高INR值的情况很普遍，导致资源利用增加。
