美国食品药品监督管理局哨兵系统内利伐沙班安全性的前瞻性监测试点
Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.
作者信息
Chrischilles Elizabeth A, Gagne Joshua J, Fireman Bruce, Nelson Jennifer, Toh Sengwee, Shoaibi Azadeh, Reichman Marsha E, Wang Shirley, Nguyen Michael, Zhang Rongmei, Izem Rima, Goulding Margie R, Southworth Mary Ross, Graham David J, Fuller Candace, Katcoff Hannah, Woodworth Tiffany, Rogers Catherine, Saliga Ryan, Lin Nancy D, McMahill-Walraven Cheryl N, Nair Vinit P, Haynes Kevin, Carnahan Ryan M
机构信息
Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA.
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
出版信息
Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018 Jan 10.
PURPOSE
The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance.
METHODS
In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods.
RESULTS
Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71).
CONCLUSIONS
This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety.
目的
美国食品药品监督管理局的哨兵系统开发了用于序贯监测的工具。
方法
在非瓣膜性心房颤动患者中，我们采用倾向评分匹配和Cox回归，对利伐沙班新使用者与华法林使用者的结局进行序贯比较。在2个监测期内，对总共36173名利伐沙班起始使用者和79520名华法林起始使用者进行了可变比例匹配。
结果
在缺血性卒中（IS）（第一期）和颅内出血（ICH）（第二期）方面观察到有利于利伐沙班的具有统计学意义的信号，在胃肠道出血（GIB）（第二期）方面观察到有利于华法林的信号。在使用住院病历的主要位置诊断以提高定义特异性的随访分析中，利伐沙班与华法林新使用者相比，IS的风险比（HR）为0.61（0.47，0.79），GIB为1.47（1.29，1.67），ICH为0.71（0.50，1.01）。对于GIB，HR随年龄而异：<66岁，HR = 0.88（0.60，1.30）；66岁及以上，HR = 1.49（1.30，1.71）。
结论
本研究证明了哨兵系统进行前瞻性安全性监测的能力，并且未引发关于利伐沙班安全性的新担忧。
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