Study Highlights Benefits of Novel Anticoagulants



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Direct oral anticoagulants (DOACs), particularly apixaban, reduce the risk of major bleeding compared with warfarin in patients with or without atrial fibrillation, according to British researchers who should reassure on the safety of Unlike warfarin, OADs do not require regular testing to check blood levels and are therefore increasingly used as an alternative to the older drug.

However, while previous clinical trials have suggested that AODs have a further, the majority of observational studies comparing DOACs with warfarin have focused only on patients with AF.

As Yana Vinogradova, researcher, The Division of Primary Care, University of Nottingham, and her colleagues point out that this "only accounts for half of the users of anticoagulants".

Anticoagulant Analysis

The current analysis therefore included more than 195,000 patients receiving anticoagulants, nearly half of whom had no FA, and nearly one-third were taking drugs other than warfarin.

Results, published online by BMJ on July 4, apixaban was associated with a lower risk of major bleeding, both cerebral and gastric in patients with and without AF versus warfarin .

While the risk of major bleeding was reduced with dabigatran in patients with FA and rivaroxaban in non-patients Patients with FA versus warfarin, rivaroxaban and low dose apixaban were related to a risk increased death.

While acknowledging the limitations of their analysis, the team writes: "Our study showed that the risk of major bleeding is lower in patients"

They add: "Our results give a first indication reassuring risk profiles for all patients taking anticoagulants, compared to those taking anticoagulants. To examine the risks and benefits of DOACs versus warfarin in a real-world setting, the team collected data from the QResearch and Clinical Practice Research Datalink primary care databases, both of which are representative of population of the United Kingdom.

They focused on patients aged 21 to 99 who received warfarin, dabigatran, rivaroxaban and apixaban between 2011 and 2016, with the exception of those who had an anticoagulant prescription in the previous 12 months. hospital admissions data, as well as mortality data provided by the Office of National Statistics (ONS), along with the main findings of major bleeding leading to hospitalization or death.

In addition, secondary outcomes include ischemic stroke, venous thromboembolism and all-cause mortality, all analyzes being adjusted for demographic and clinical variables, including ethnicity, smoking status , consumption of alcohol, deprivation, disorders of the

A total of 196,061 patients from both databases were included in the study, including 132,231 on warfarin, 7744 on dabigatran, 37,863 on rivaroxaban and 18,223 on apixaban [19659]. , 103,270 (53%) of patients were diagnosed with AF, while the remaining 92,791 (47%) were taking anticoagulants for other conditions.

Compared with warfarin, apixaban was associated with a reduced risk of major bleeding and intracranial hemorrhage in patients with AF, at an adjusted risk rate (HR) of 0.66 and 0.40 , respectively.

In patients without FA, apixaban was compared with warfarin, associated with a reduced risk of major bleeding, at a HR of 0.60. , gastrointestinal bleeding, at HR 0.55, and upper gastrointestinal bleeding (0.55).

Dabigatran was associated with a decreased risk of intracranial bleeding compared with warfarin in AF patients (HR 0.45), while rivaroxa prohibition was associated with a reduced risk of intracranial bleeding compared with with warfarin in non-AF patients (HR 0.54).

Rivaroxaban was associated with an increased risk of all-cause mortality compared to warfarin in AF (HR 1.19) and AF (HR 1.51) patients. Interestingly, low-dose apixaban was also associated with an increased risk of mortality in AF and non-AF patients at 1.27 and 1.34 HR respectively

Narrower monitoring [19659005] The team writes that these observations may reflect The team calculates that, overall, apixaban had the lowest number needed to treat more than 6 months to avoid a major bleeding compared to warfarin, in 182 patients with AF and in patients with AF. 138 non-AF patients

Rivaroxaban had the lowest number necessary to impair the observation of an additional death compared to warfarin for 6 months, to 202 AF patients and 61 non-AF patients . the results with anticoagulants in patients without AF, they point out that "this group, however, includes patients undergoing preventive treatment of venous thromboembolism or ischemic cerebrovascular accident after the hip or knee repl steel, fractures or dors Other operations and detailed study of this group would require further division. "

This work was supported by the National Institute for Health Research (NIHR) with a 11th round grant from the School of Primary Care Research (SPCR) (reference number 304) This article presents independent research funded by the NIHR SPCR

Julia Hippisley-Cox is professor of clinical epidemiology at the University of Nottingham and unpaid director of QResearch, a non-profit organization that is a partnership between the University of Nottingham and EMIS (commercial IT vendor for 60% of UK general practice). She is also a paid administrator of ClinRisk Limited, which produces open source and closed source software to ensure the reliable and scalable implementation of clinical risk algorithms (including QRISK2) in clinical computer systems to improve patient care. patients. No other conflict declared.

BMJ 2018; 362: k2505 doi: 10.1136 / bmj.k2505. Full text

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