Association Between Dabigatran vs Warfarin and Risk of Osteoporotic Fractures Among Patients With Nonvalvular Atrial Fibrillation

Association Between Dabigatran vs Warfarin and Risk of Osteoporotic Fractures Among Patients With Nonvalvular Atrial Fibrillation
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DOI:
10.1001/jama.2017.1363
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发表时间:
2017-03-21
影响因子:
120.7
通讯作者:
Wong, Ian C. K.
Wong, Ian C. K.
中科院分区:
医学1区
文献类型:
--
作者:
Lau, Wallis C. Y.;Chan, Esther W.;Wong, Ian C. K.

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重要性:达比加群用于非瓣膜性房颤(NVAF)患者骨质疏松性骨折的风险尚不清楚。目的探讨达比加群与华法林治疗非瓣膜性房颤发生骨质疏松性骨折的风险。设计、环境和参与者采用香港医院管理局管理的全民数据库进行回顾性队列研究。2010年至2014年期间新诊断为非瓣膜性房颤并使用达比加群或华法林治疗的患者,随访至2016年7月31日,倾向评分为1:2。研究期间使用达比加群或华法林的情况。使用泊松回归比较达比加群和华法林使用者骨质疏松性髋部骨折和椎体骨折的风险。计算相应的发病率比(IRR)和95% ci的绝对风险差(ARD)。结果:在51 496例新诊断为非瓣膜性房颤动的患者中,8152例新使用达比加群(n = 3268)和华法林(n = 4884)的患者通过倾向评分匹配(50%为女性,平均[SD]年龄为74岁)。随访期间,104例(1.3%)患者发生骨质疏松性骨折(达比加群32例[1.0%];华法林72例[1.5%])。泊松回归分析结果显示,与华法林相比,使用达比加群与骨质疏松性骨折的风险显著降低相关(0.7 vs 1.1 / 100人-年;ARD / 100人-年,-0.68 [95% CI, -0.38至-0.86];IRR, 0.38 [95% CI, 0.22至0.66])。在有跌倒史、骨折史或两者都有的患者中,与较低风险的关联具有统计学意义(达比加群vs华法林,1.6 vs 3.6 / 100人-年;ARD / 100人-年,-3.15 [95% CI, -2.40至-3.45];IRR, 0.12 [95% CI, 0.04至0.33]),但在没有病史的患者中没有(0.6 vs 0.7 / 100人-年;ARD / 100人-年,-0.04 [95% CI, 0.67至-0.39];IRR, 0.95 [95% CI, 0.45至1.96])(相互作用的P值,
IMPORTANCE The risk of osteoporotic fracture with dabigatran use in patients with nonvalvular atrial fibrillation (NVAF) is unknown.OBJECTIVE To investigate the risk of osteoporotic fracture with dabigatran vs warfarin in patients with NVAF.DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study using a population-wide database managed by the Hong Kong Hospital Authority. Patients newly diagnosed with NVAF from 2010 through 2014 and prescribed dabigatran or warfarin were matched by propensity score at a 1: 2 ratio with follow-up until July 31, 2016.EXPOSURES Dabigatran or warfarin use during the study period. MAIN OUTCOMES AND MEASURES Risk of osteoporotic hip fracture and vertebral fracture was compared between dabigatran and warfarin users using Poisson regression. The corresponding incidence rate ratio (IRR) and absolute risk difference (ARD) with 95% CIs were calculated.RESULTS Among 51 496 patients newly diagnosed with NVAF, 8152 new users of dabigatran (n = 3268) and warfarin (n = 4884) were matched by propensity score (50% women; mean [SD] age, 74 [11] years). Osteoporotic fracture developed in 104 (1.3%) patients during follow-up (32 dabigatran users [1.0%]; 72 warfarin users [1.5%]). Results of Poisson regression analysis showed that dabigatran use was associated with a significantly lower risk of osteoporotic fracture compared with warfarin (0.7 vs 1.1 per 100 person-years; ARD per 100 person-years, -0.68 [95% CI, -0.38 to -0.86]; IRR, 0.38 [95% CI, 0.22 to 0.66]). The association with lower risk was statistically significant in patients with a history of falls, fractures, or both (dabigatran vs warfarin, 1.6 vs 3.6 per 100 person-years; ARD per 100 person-years, -3.15 [95% CI, -2.40 to -3.45]; IRR, 0.12 [95% CI, 0.04 to 0.33]), but not in those without a history (0.6 vs 0.7 per 100 person-years; ARD per 100 person-years, -0.04 [95% CI, 0.67 to -0.39]; IRR, 0.95 [95% CI, 0.45 to 1.96]) (P value for interaction,