Post-Marketing Pharmacovigilance Study for the Active Detection and Evaluation of Major Bleeding in Rivaroxaban Users With Non-Valvular Atrial Fibrillation

Tamayo, Sally; Patel, Manesh R.; Yuan, Zuyi; Hopf, K; Peacock, W. Frank

doi:10.1016/s0735-1097(15)60281-9

Cited by 8 publications

(5 citation statements)

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“…Descriptive data were reported including patient demographics, comorbidities, concomitant medications, bleeding hospitalisations and management, bleeding characteristics, and outcomes. 16,17…”

Section: Resultsmentioning

confidence: 99%

“…For the current analysis, the database 15 Similarly, an 18-month update was presented at the 2015 American College of Cardiology Scientific Session on 15 th March 2015. 16 Peacock et al 17 presented the 2-year preliminary data at the ESC Congress on 31 st August 2015.…”

Section: United States Department Of Defense Post-marketing Safety Su...mentioning

confidence: 99%

“…Overall, 42.3% of patients with major bleeding were transferred to an intensive care unit, and 51.5% received a blood transfusion. 16,17…”

Section: Safety: Major Bleedingmentioning

confidence: 99%

“…Of the fatal bleedings, 74.3% were intracranial haemorrhages and 25.7% were gastrointestinal bleedings. 16,17 Tamayo et al 16,17 also presented the results of the cumulative incidences of major bleeding according to rivaroxaban dose, which were produced through an earlier interim analysis on the first 30,813 patients (Figure 2).…”

Section: Safety: Mortality Ratesmentioning

confidence: 99%

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International, Large-Scale, Real-World Clinical Data Confirm the Safety Profile of Rivaroxaban

Camm

2015

EMJ Cardiol

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Rivaroxaban is a direct factor Xa inhibitor and a non-vitamin K antagonist (VKA) novel oral anticoagulant (NOAC) approved for a number of indications. It has been approved since 2011 by both the United States Food and Drug Administration and the European Medicines Agency for use in patients with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke and systemic embolism. However, anticoagulant therapy (both VKAs and NOACs) has been associated with an increased risk of bleeding. Although the majority of bleeding events are minor from a clinical standpoint (e.g. ecchymoses), major bleeding events have also been reported. This warrants the need for robust and large-scale clinical and safety data to guide physicians in patient selection, risk stratification, and treatment choice. While NOACs have been subject to a number of randomised clinical trials, observational studies, and real-world registries, large-scale observational studies are still scarce. This article reviews the newly published data from the XANTUS and the United States Department of Defense post-marketing safety surveillance studies, two landmark real-world observational studies on rivaroxaban use and safety in NVAF patients, and puts them in perspective with regard to clinical trial data and other real-world data. Both sets of results were presented at the European Society of Cardiology Congress on 31st August, 2015. This data collection represents more than 45,000 patients from 22 countries.

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Section: Resultsmentioning

confidence: 99%

Section: United States Department Of Defense Post-marketing Safety Su...mentioning

confidence: 99%

“…Overall, 42.3% of patients with major bleeding were transferred to an intensive care unit, and 51.5% received a blood transfusion. 16,17…”

Section: Safety: Major Bleedingmentioning

confidence: 99%

Section: Safety: Mortality Ratesmentioning

confidence: 99%

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International, Large-Scale, Real-World Clinical Data Confirm the Safety Profile of Rivaroxaban

Camm

2015

EMJ Cardiol

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“…72 Updated data of this study recently presented at 2015 American College of Cardiology congress showed that in the first 18 months of the study, with 31 833 patients taking rivaroxaban, the incidence of major bleeding and fatal bleeding remained 2.85 and 0.09 per 100 personyears, respectively. 75 A recent study performed in primary care setting in Switzerland included 537 consecutive patients with NVAF who started treatment with rivaroxaban. Mean age of patients was 73 years, 57% were men, mean CHADS 2 score was 2.2, In ROCKET-AF, patients with mitral stenosis or artificial valve prostheses were excluded.…”

Section: Patients With Heart Failure 47mentioning

confidence: 99%

Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Clinical Practice: Focus on Rivaroxaban in Stroke Prevention in Patients With Atrial Fibrillation

Sanmartín-Fernández

Marzal-Martín

2016

Clin Appl Thromb Hemost

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Despite direct oral anticoagulants (DOACs) have overcome the most relevant limitations of vitamin K antagonists, many patients with atrial fibrillation are not receiving the appropriate anticoagulant therapy. In addition, when patients are anticoagulated with DOACs, some of them are not taking the dose recommended in the summary of product characteristics. This may be related, at least in part, to the concern about the applicability of findings from randomized clinical trials to real-life patients. In this context, performing studies in daily clinical practice to assess the efficacy and safety of DOACs in real-world setting is mandatory. The aim of this review is to update the current evidence regarding safety of rivaroxaban in clinical practice. The Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) showed that rivaroxaban was at least as effective as warfarin for preventing stroke or systemic embolism, with similar rates of major bleeding but with lesser risk of intracranial and fatal bleedings. Data from noninterventional studies and registries have confirmed the good results of ROCKET-AF. Even more, rates of bleeding may be inferior in real-life patients, since they have a lower risk profile than those included in ROCKET-AF.

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Novel oral anticoagulants in non-valvular atrial fibrillation: Pharmacological properties, clinical trials, guideline recommendations, new antidote drugs and real-world data

Kocabaş

Kaya

Avcı

2016

International Journal of the Cardiovascular Academy

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Post-Marketing Pharmacovigilance Study for the Active Detection and Evaluation of Major Bleeding in Rivaroxaban Users With Non-Valvular Atrial Fibrillation

Cited by 8 publications

References 0 publications

International, Large-Scale, Real-World Clinical Data Confirm the Safety Profile of Rivaroxaban

International, Large-Scale, Real-World Clinical Data Confirm the Safety Profile of Rivaroxaban

Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Clinical Practice: Focus on Rivaroxaban in Stroke Prevention in Patients With Atrial Fibrillation

Novel oral anticoagulants in non-valvular atrial fibrillation: Pharmacological properties, clinical trials, guideline recommendations, new antidote drugs and real-world data

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