Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK
Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
BMJ Open. 2020 May 30;10(5):e033357. doi: 10.1136/bmjopen-2019-033357.
There is concern about long-term safety of direct oral coagulants (DOACs) in clinical practice. Our aim was to investigate whether the introduction of DOACs compared with vitamin-K antagonists in England was associated with a change in admissions for bleeding or thromboembolic complications.
5508 General practitioner (GP) practices in England between 2011 and 2016.
All GP practices in England with a registered population size of greater than 1000 that had data for all 6 years.
The rate of emergency admissions to hospital for bleeding or thromboembolism, per 100 000 population for each GP practice in England.
The annual number of DOAC items prescribed for each GP practice population as a proportion of all anticoagulant items prescribed.
This longitudinal ecological study used panel regression models to investigate the association between trends in DOAC prescribing within GP practice populations and trends in emergency admission rates for bleeding and thromboembolic conditions, while controlling for confounders.
For each additional 10% of DOACs prescribed as a proportion of all anticoagulants, there was a 0.9% increase in bleeding complications (rate ratio 1.008 95% CI 1.003 to 1.013). The introduction of DOACs between 2011 and 2016 was associated with additional 4929 (95% CI 2489 to 7370) emergency admissions for bleeding complications. Increased DOAC prescribing was associated with a slight decline in admission for thromboembolic conditions.
Our data show that the rapid increase in prescribing of DOACs after changes in National Institute for Health and Care Excellence guidelines in 2014 may have been associated with a higher rate of emergency admissions for bleeding conditions. These consequences need to be considered in assessing the benefits and costs of the widespread use of DOACs.
人们对直接口服抗凝剂（DOAC）在临床实践中的长期安全性存在担忧。本研究旨在调查与维生素 K 拮抗剂相比，DOAC 在英国的引入是否与出血或血栓栓塞并发症的住院治疗变化相关。
2011 年至 2016 年期间，英格兰的 5508 家全科医生（GP）诊所。
所有在英格兰注册人口超过 1000 人的 GP 诊所，且所有 6 年的数据均可用。
英格兰每个 GP 诊所的每 100000 人因出血或血栓栓塞而急诊入院的人数。
每个 GP 诊所人群中 DOAC 的年处方数量占所有抗凝药物处方数量的比例。
这是一项纵向生态研究，使用面板回归模型，在控制混杂因素的情况下，调查 GP 诊所人群中 DOAC 处方趋势与出血和血栓栓塞情况的急诊入院率趋势之间的关联。
DOAC 处方占所有抗凝药物的比例每增加 10%，出血并发症的发生率就会增加 0.9%（比值比 1.008，95%CI 1.003 至 1.013）。2011 年至 2016 年间 DOAC 的引入与出血并发症的急诊入院人数增加了 4929 例（95%CI 2489 至 7370）有关。DOAC 处方的增加与血栓栓塞疾病的入院率略有下降有关。
我们的数据表明，2014 年国家卫生与保健卓越研究所指南改变后，DOAC 的处方迅速增加，可能与出血情况的急诊入院率升高有关。在评估 DOAC 广泛使用的益处和成本时，需要考虑到这些后果。
