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在一项基于法国健康保险数据库全国人群的横断面研究中,房颤直接口服抗凝治疗的起始趋势。

Trends in initiation of direct oral anticoagulant therapies for atrial fibrillation in a national population-based cross-sectional study in the French health insurance databases.

作者信息

Huiart Laetitia, Ferdynus Cyril, Renoux Christel, Beaugrand Amélie, Lafarge Sophie, Bruneau Léa, Suissa Samy, Maillard Olivier, Ranouil Xavier

机构信息

Unité de Soutien Méthodologique, CHU de la Réunion, Saint-Denis, France.

CHU de la Réunion, INSERM, CIC1410, Saint-Pierre, France.

出版信息

BMJ Open. 2018 Mar 30;8(3):e018180. doi: 10.1136/bmjopen-2017-018180.

Abstract

OBJECTIVE

Unlike several other national health agencies, French health authorities recommended that the newer direct oral anticoagulant (DOAC) agents only be prescribed as second choice for the treatment of newly diagnosed non-valvular atrial fibrillation (NVAF), with vitamin K antagonists (VKA) remaining the first choice. We investigated the patterns of use of DOACs versus VKA in the treatment of NVAF in France over the first 5 years of DOAC availability. We also identified the changes in patient characteristics of those who initiated DOAC treatment over this time period.

METHODS

Based on the French National Health Administrative Database, we constituted a population-based cohort of all patients who were newly treated for NVAF between January 2011 and December 2015. Trends in drug use were described as the percentage of patients initiating each drug at the time of treatment initiation. A multivariate analysis using logistic regression model was performed to identify independent sociodemographic and clinical predictors of initial anticoagulant choice.

RESULTS

The cohort comprised 814 446 patients who had received a new anticoagulant treatment for NVAF. The proportion of patients using DOACs as initial anticoagulant therapy reached 54% 3 months after the Health Ministry approved the reimbursement of dabigatran for NVAF, and 61% by the end of 2015, versus VKA use. In the multivariate analysis, we found that DOAC initiators were younger and healthier overall than VKA initiators, and this tendency was reinforced over the 2011-2014 period. DOACs were more frequently prescribed by cardiologists in 2012 and after (adjusted OR in 2012: 2.47; 95% CI 2.40 to 2.54).

CONCLUSION

Despite recommendations from health authorities, DOACs have been rapidly and massively adopted as initial therapy for NVAF in France. Observational studies should account for the fact that patients selected to initiate DOAC treatment are healthier overall, as failure to do so may bias the risk-benefit assessment of DOACs.

摘要

目的

与其他几个国家卫生机构不同,法国卫生当局建议,新型直接口服抗凝剂(DOAC)仅作为新诊断非瓣膜性心房颤动(NVAF)治疗的第二选择,维生素K拮抗剂(VKA)仍为首选。我们调查了在法国DOAC上市的头5年里,DOAC与VKA在NVAF治疗中的使用模式。我们还确定了在此期间开始DOAC治疗的患者特征变化。

方法

基于法国国家卫生行政数据库,我们构建了一个以人群为基础的队列,纳入了2011年1月至2015年12月期间所有新接受NVAF治疗的患者。药物使用趋势以治疗开始时启动每种药物的患者百分比来描述。使用逻辑回归模型进行多变量分析,以确定初始抗凝剂选择的独立社会人口统计学和临床预测因素。

结果

该队列包括814446例接受过NVAF新抗凝治疗的患者。在卫生部批准达比加群用于NVAF报销3个月后,使用DOAC作为初始抗凝治疗的患者比例达到54%,到2015年底与使用VKA相比为61%。在多变量分析中,我们发现与VKA启动者相比,DOAC启动者总体上更年轻、更健康,并且在2011 - 2014年期间这种趋势有所加强。2012年及之后,心脏病专家更频繁地开具DOAC处方(2012年调整后的比值比:2.47;95%置信区间2.40至2.54)。

结论

尽管有卫生当局的建议,但在法国DOAC已迅速且大量地被用作NVAF的初始治疗。观察性研究应考虑到选择开始DOAC治疗的患者总体上更健康这一事实,因为不这样做可能会使DOAC的风险效益评估产生偏差。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0e40/5884337/e09d8c7de2e9/bmjopen-2017-018180f01.jpg

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