利伐沙班与华法林及达比加群用于房颤治疗：丹麦常规医疗中的比较有效性与安全性

Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care.

作者信息

Gorst-Rasmussen Anders, Lip Gregory Y H, Bjerregaard Larsen Torben

机构信息

Unit of Clinical Biostatistics and Bioinformatics, Aalborg University Hospital, Aalborg, Denmark.

Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Health, Aalborg University, Aalborg, Denmark.

出版信息

Pharmacoepidemiol Drug Saf. 2016 Nov;25(11):1236-1244. doi: 10.1002/pds.4034. Epub 2016 May 27.

DOI:10.1002/pds.4034

PMID:27229855

Abstract

PURPOSE

To evaluate effectiveness and safety of rivaroxaban versus warfarin or dabigatran etexilate in a prospective cohort of routine care non-valvular atrial fibrillation (AF) patients during February 2012 to August 2014.

METHODS

We identified in nationwide health registries a cohort of AF patients who were new-users of rivaroxaban 15 mg (R15) or 20 mg (R20); dabigatran 110 mg (D110) or 150 mg (D150); or warfarin. Propensity-adjusted Cox regression was used to compare outcome rates in four settings: 'R15 vs. warfarin'; 'R15 vs. D110'; 'R20 vs. warfarin'; and 'R20 vs. D150'.

RESULTS

Rivaroxaban users (R15: n = 776; R20: n = 1629) were older and with more comorbidities than warfarin (n = 11 045) and dabigatran users (D110: n = 3588; D150: n = 5320). Rivaroxaban 15-mg users had the overall highest crude mortality rate. After propensity adjustment, rivaroxaban had lower stroke rates vs. warfarin (R15: hazard ratio [HR] 0.46, 95% confidence interval [CI]: 0.26-0.82; R20 HR: 0.72, 95%CI: 0.51-1.01), and similar stroke rates vs. dabigatran. The bleeding rate was similar to warfarin and moderately higher vs. dabigatran (R15 vs. D110 HR: 1.28, 95%CI: 0.82-2.01; R20 vs. D150 HR: 1.81, 95%CI: 1.25-2.62). The mortality rate was higher vs. dabigatran (R15 vs. D110 HR: 1.43, 95%CI: 1.13-1.81; R20 vs. D150 HR: 1.52, 95%CI: 1.06-2.19).

CONCLUSIONS

Rivaroxaban was associated with similar or lower stroke rates, but higher bleeding and mortality rates. Channeling of rivaroxaban towards elderly and less healthy patients may have generated residual confounding. In particular, our findings cannot stand alone when deciding which oral anticoagulant to prescribe. Copyright © 2016 John Wiley & Sons, Ltd.

摘要

目的

评估2012年2月至2014年8月期间，在接受常规治疗的非瓣膜性心房颤动（AF）患者前瞻性队列中，利伐沙班与华法林或达比加群酯相比的有效性和安全性。

方法

我们在全国健康登记处识别出一组AF患者，他们是利伐沙班15毫克（R15）或20毫克（R20）、达比加群110毫克（D110）或150毫克（D150）的新使用者，或华法林的新使用者。采用倾向调整Cox回归比较四种情况下的结局发生率：“R15与华法林”；“R15与D110”；“R20与华法林”；以及“R20与D150”。

结果

与华法林使用者（n = 11045）和达比加群使用者（D110：n = 3588；D150：n = 5320）相比，利伐沙班使用者（R15：n = 776；R20：n = 1629）年龄更大，合并症更多。利伐沙班15毫克使用者的总体粗死亡率最高。倾向调整后，与华法林相比，利伐沙班的卒中发生率较低（R15：风险比[HR] 0.46，95%置信区间[CI]：0.26 - 0.82；R20 HR：0.72，95%CI：0.51 - 1.01），与达比加群的卒中发生率相似。出血率与华法林相似，与达比加群相比略高（R15与D110 HR：1.28，95%CI：0.82 - 2.01；R20与D150 HR：1.81，95%CI：1.25 - 2.62）。死亡率高于达比加群（R15与D110 HR：1.43，95%CI：1.13 - 1.81；R20与D150 HR：1.52，95%CI：1.06 - 2.19）。