Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

Chen, Esa Y H; Diug, Basia; Bell, Jane; Namara, Kevin Mc; Dooley, Michael; Kirkpatrick, Carl M.; McNeil, John J; Caughey, Gillian E.; Ilomäki, Jenni

doi:10.1177/2042098615618171

Cited by 8 publications

(7 citation statements)

References 16 publications

(17 reference statements)

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“…In contrast to our study, spontaneous reports to the Australian Therapeutic Goods Administration between June 2009 and May 2014 revealed more reports of hemorrhages associated with dabigatran than those associated with rivaroxaban (504 vs 240). 34 Compared to this Australian study, our study revealed three times more reports of bleeding due to dabigatran (504 vs 1,518) and less than half the number of reports of bleeding due to rivaroxaban (93 vs 240). 17 The randomized evaluation of long-term anticoagulation therapy reported that the frequency of major gastrointestinal bleeding was significantly higher with dabigatran use than that with warfarin use.…”

Section: Discussioncontrasting

confidence: 77%

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015

Alshammari

Ata

Alhawassi

et al. 2018

TCRM

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PurposeTo analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years.MethodsReports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases.ResultsA total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65–12.97) for dabigatran, 15.61 (95% CI 14.42–16.90) for warfarin, and 18.86 (95% CI 15.31–23.23) for rivaroxaban.ConclusionsThe signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.

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Section: Discussioncontrasting

confidence: 77%

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015

Alshammari

Ata

Alhawassi

et al. 2018

TCRM

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“…Therefore, an examination of the impact of the audiovisual tool on patients’ knowledge of and satisfaction with newer oral anticoagulants, particularly in patients for whom warfarin is contraindicated, could be our next goal, as those agents may share similar educational aspects (e.g., the importance of taking the medicine at the same time each day, self-awareness of bleeding tendency, and reporting significant signs and symptoms immediately to physicians or the ACC). [ 41 ]…”

Section: Discussionmentioning

confidence: 99%

The impact of a pharmacist-led warfarin educational video in a Saudi setting

Shilbayeh

2020

J Pharm Bioall Sci

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A BSTRACT Context: Internationally, various warfarin education strategies have been described in the medical literature and delivered by a variety of health-care providers. However, none of these were tested in a Saudi setting. Aim: The aim of this study was to assess the impact of pharmacist interventions via an educational video on improving patient knowledge of and satisfaction with warfarin therapy and the international normalized ratio (INR). Setting and Design: This study adopted a prospective pre- and posttest design and enrolled 91 patients from an anticoagulant clinic at King Khaled University Hospital in Riyadh, Saudi Arabia, between September 2017 and February 2018. Materials and Methods: All patients completed the Anticoagulation Knowledge Assessment (AKA) and Anti-Clot Treatment Satisfaction (ACTS) scales. Subsequently, the patients watched a 10-min educational video containing basic information regarding warfarin and were given relevant informative booklets. The patients were reassessed after a mean follow-up period of approximately 52 days. Results: In total, 85 patients completed the study. The impact of the intervention on patient knowledge was highly significant (mean difference = 17.7%, 95% confidence interval (CI) = 21.75–13.58, P < 0.000). In addition, the patients showed significant increases in their ACTS benefits subscale scores (mean difference = 0.73, 95% CI = 1.22–0.24, P = 0.004). Despite being long-term warfarin users, the patients’ INRs had a greater tendency to be within the target range after the intervention (56.63% ± 35% vs. 64.72% ± 35% of the time; mean difference, 8.1 percentage points; effect size = 0.23). However, there was no significant effect on patients’ perceptions of the warfarin burden. Conclusion: This study provided evidence that a pharmacist-led audiovisual intervention via an educational video coupled with an informational booklet effectively improved patients’ knowledge retention and satisfaction with warfarin therapy benefits. Longer studies are needed to determine the impact of this intervention on patients’ perceptions of warfarin burdens and their INRs.

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“…A study based in Australia showed both oral anticoagulants to be associated with considerable amount of hemorrhage within the first 30 days [13]. Two hundred and forty hemorrhagic adverse events were observed with rivaroxaban whereas 504 events were observed among patients treated with dabigatran.…”

Section: Discussionmentioning

confidence: 99%

Bleeding outcomes associated with rivaroxaban and dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis

Bundhun

Soogund

Teeluck

et al. 2017

BMC Cardiovasc Disord

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BackgroundWarfarin is commonly used as a secondary prevention of stroke in patients with atrial fibrillation (AF). However, limitations have been observed even with the use of this medication. Recently, several newer direct oral anticoagulants (DOACs) have been approved for use by the food and drug administrations. Unfortunately, these newer drugs have seldom been compared directly with each other. Therefore, this study aimed to compare the bleeding events associated with rivaroxaban and dabigatran in patients treated for non-valvular AF.MethodsEMBASE, Medline (National Library of Medicine) and the Cochrane Central Registry of Controlled Trials were searched for studies comparing rivaroxaban with dabigatran using the terms ‘rivaroxaban, dabigatran and atrial fibrillation’. Primary endpoints were: any bleeding outcomes, intracranial bleeding and gastro-intestinal (GI) bleeding. Secondary outcomes included stroke/systemic embolism (SE)/transient ischemic attack (TIA), venous thromboembolism and mortality. Odds ratios (OR) with 95% confidence intervals (CIs) were calculated. The pooled analyses were carried out with RevMan 5.3 software. All the authors had full access to the data and approved the manuscript as written.ResultsA total number of 4895 patients were included. This analysis showed that rivaroxaban was not associated with a significantly higher bleeding event when compared to dabigatran (OR: 1.28, 95% CI: 0.95–1.72; P = 0.11). GI bleeding was similarly manifested between these two DOACs (OR: 0.98, 95% CI: 0.43–2.25; P = 0.97). Even if intracranial bleeding was higher with the use of rivaroxaban, (OR: 2.18, 95% CI: 0.51–9.25; P = 0.29), the result was not statistically significant. Moreover, stroke/SE/TIA and venous thromboembolism were also not significantly different (OR: 0.81, 95% CI: 0.53–1.23; P = 0.32) and (OR: 2.06, 95% CI: 0.73–5.82; P = 0.17) respectively. However, even if mortality favored dabigatran (OR: 1.42, 95% CI: 0.99–2.06; P = 0.06), this result only approached statistical significance.ConclusionHead to head comparison showed that rivaroxaban was not associated with significantly higher bleeding events compared to dabigatran. Intracranial bleeding, GI bleeding, stroke/SE/TIA, venous thromboembolism and mortality were also not significantly different between these two DOACs. However, due to the limited number of patients analyzed, and which were mainly obtained from observational studies, this hypothesis might only be confirmed in future randomized trials. Furthermore, the CHADS2-VASC and HAS-BLED score which might play an important role in predicting bleeding risks should also not be ignored.

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Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

Cited by 8 publications

References 16 publications

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015

The impact of a pharmacist-led warfarin educational video in a Saudi setting

Bleeding outcomes associated with rivaroxaban and dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis

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Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

Cited by 8 publications

References 16 publications

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010&ndash;2015

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010&ndash;2015

The impact of a pharmacist-led warfarin educational video in a Saudi setting

Bleeding outcomes associated with rivaroxaban and dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis

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Product

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Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010–2015