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https://hdl.handle.net/2440/106758
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dc.contributor.author | Caughey, G. | - |
dc.contributor.author | Kalisch Ellett, L. | - |
dc.contributor.author | Barratt, J. | - |
dc.contributor.author | Shakib, S. | - |
dc.date.issued | 2017 | - |
dc.identifier.citation | Therapeutic Advances in Drug Safety, 2017; 8(5):157-164 | - |
dc.identifier.issn | 2042-0986 | - |
dc.identifier.issn | 2042-0994 | - |
dc.identifier.uri | http://hdl.handle.net/2440/106758 | - |
dc.description.abstract | Introduction: Little is known about the potential safety issues associated with apixaban in clinical practice and their reporting in spontaneous adverse event (SAE) databases. Objective: To describe SAE reports associated with the oral anticoagulant apixaban from Australia, Canada and USA and to examine associated concomitant medicine use. Methods: SAE report databases from Australia, Canada and the USA were examined for all reports of adverse events associated with apixaban and concomitant medicines from 1 January 2012 to 30 September 2014. Disproportionality analysis (proportional reporting ratio (PRR) and reporting odds ratio (ROR)) was conducted for the quantitative detection of signals using the USA database. Results: There were 97 SAE reports associated with apixaban from Australia, 77 from Canada and 2877 from the USA. Reporting of haemorrhage (any type) was common, ranging from 18% for USA to 31% for Australia. Gastrointestinal (GI) haemorrhage was the most commonly reported haemorrhage, accounting for approximately 10% of adverse event reports across all countries. Positive signals were confirmed in the USA data (haemorrhage (any type) PRR, 12.1; χ2, 5582.2 and ROR, 13.4; 95% CI: 12.13-14.6; GI haemorrhage PRR, 11.8; χ2, 2325.4 and ROR, 12.3; 95% CI, 10.8-14.0). Reporting of concomitant use of medicines with the potential to increase bleeding risk ranged from 47.6% in Canada to 65.5% in Australia. Conclusion: A large proportion of adverse event reports for apixaban were associated with use of concomitant medicines which may have increased the risk of haemorrhage. | - |
dc.description.statementofresponsibility | Gillian E. Caughey, Lisa M. Kalisch Ellett, John D. Barratt and Sepehr Shakib | - |
dc.language.iso | en | - |
dc.publisher | Sage | - |
dc.rights | © The Author(s), 2017. Reprints and permissions: http://www.sagepub.co.uk/ journalsPermissions.nav | - |
dc.source.uri | http://dx.doi.org/10.1177/2042098616689771 | - |
dc.subject | Apixaban; novel oral anticoagulant; haemorrhage; adverse event; spontaneous reports | - |
dc.title | Apixaban, concomitant medicines and spontaneous reports of haemorrhagic events | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1177/2042098616689771 | - |
dc.relation.grant | http://purl.org/au-research/grants/nhmrc/1040938 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Caughey, G. [0000-0003-1192-4121] | - |
dc.identifier.orcid | Shakib, S. [0000-0002-7199-5733] | - |
Appears in Collections: | Aurora harvest 3 Medicine publications |
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