Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care
Objectives To investigate effects of appropriately and inappropriately dosed apixaban/rivaroxaban versus warfarin on effectiveness and safety outcomes in patients with non-valvular atrial fibrillation (NVAF).Design Cohort study with nested case–control analyses using primary care electronic health r...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e059311.full |
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| author | Luis Alberto García Rodríguez Pareen Vora Luke Roberts Gunnar Brobert Samuel Fatoba María Eugenia Sáez Antonio González-Pérez |
| author_facet | Luis Alberto García Rodríguez Pareen Vora Luke Roberts Gunnar Brobert Samuel Fatoba María Eugenia Sáez Antonio González-Pérez |
| author_sort | Luis Alberto García Rodríguez |
| collection | DOAJ |
| description | Objectives To investigate effects of appropriately and inappropriately dosed apixaban/rivaroxaban versus warfarin on effectiveness and safety outcomes in patients with non-valvular atrial fibrillation (NVAF).Design Cohort study with nested case–control analyses using primary care electronic health records (IQVIA Medical Research Data UK database).Setting UK primary care.Participants Patients aged ≥18 years with NVAF newly prescribed apixaban (N=14 701), rivaroxaban (N=14 288) or warfarin (N=16 175) between 1 January 2012 and 30 June 2018, and followed up to 31 December 2018.Primary and secondary outcome measures Incident cases of ischaemic stroke/systemic embolism (IS/SE) and intracranial bleeding (ICB). Cases were matched to controls on age, sex and OAC naïve status. Using logistic regression, adjusted ORs with 95% CIs were calculated for the outcomes comparing apixaban/rivaroxaban use (appropriate or inappropriate dosing based on the product label criteria) and warfarin.Results For IS/SE, ORs (95% CIs) for apixaban versus warfarin were 1.19 (0.92–1.52) for appropriate dose and 1.01 (0.67–1.51) for inappropriate dose; for rivaroxaban versus warfarin, estimates were 1.07 (0.83–1.37) for appropriate dose and 1.21 (0.78–1.88) for inappropriate dose. For ICB, ORs (95% CIs) for apixaban versus warfarin were 0.67 (0.44–1.00) for appropriate dose and 0.45 (0.21–0.95) for inappropriate dose; for rivaroxaban versus warfarin, estimates were 0.81 (0.55–1.20) for appropriate dose and 1.14 (0.56–2.31) for inappropriate dose.Conclusions Dosing appropriateness in NVAF was not associated with a significant difference in IS/SE risk or increase in ICB risk versus warfarin. These findings may reflect residual confounding and biases that were difficult to control, as also seen in other observational studies. They should, therefore, be interpreted with caution, and prescribers should adhere to the dosing instructions in the respective Summary of Product Characteristics. Further studies on this topic from real-world populations are needed. |
| format | Article |
| id | doaj-art-32d4d86ecd8e4df7aa2725edd2fc8029 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-32d4d86ecd8e4df7aa2725edd2fc80292025-01-27T13:20:08ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-059311Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary careLuis Alberto García Rodríguez0Pareen Vora1Luke Roberts2Gunnar Brobert3Samuel Fatoba4María Eugenia Sáez5Antonio González-Pérez6Spanish Centre for Pharmacoepidemiologic Research (CEIFE), Madrid, Spain2 Epidemiology, Bayer AG, Berlin, Germany3 Study Medical Experts, Bayer PLC, Reading, UKBayer AB, Stockholm, Sweden5 Medical Affairs, Bayer PLC, Reading, UKSpanish Centre for Pharmacoepidemiologic Research, Madrid, SpainSpanish Centre for Pharmacoepidemiologic Research (CEIFE), Madrid, SpainObjectives To investigate effects of appropriately and inappropriately dosed apixaban/rivaroxaban versus warfarin on effectiveness and safety outcomes in patients with non-valvular atrial fibrillation (NVAF).Design Cohort study with nested case–control analyses using primary care electronic health records (IQVIA Medical Research Data UK database).Setting UK primary care.Participants Patients aged ≥18 years with NVAF newly prescribed apixaban (N=14 701), rivaroxaban (N=14 288) or warfarin (N=16 175) between 1 January 2012 and 30 June 2018, and followed up to 31 December 2018.Primary and secondary outcome measures Incident cases of ischaemic stroke/systemic embolism (IS/SE) and intracranial bleeding (ICB). Cases were matched to controls on age, sex and OAC naïve status. Using logistic regression, adjusted ORs with 95% CIs were calculated for the outcomes comparing apixaban/rivaroxaban use (appropriate or inappropriate dosing based on the product label criteria) and warfarin.Results For IS/SE, ORs (95% CIs) for apixaban versus warfarin were 1.19 (0.92–1.52) for appropriate dose and 1.01 (0.67–1.51) for inappropriate dose; for rivaroxaban versus warfarin, estimates were 1.07 (0.83–1.37) for appropriate dose and 1.21 (0.78–1.88) for inappropriate dose. For ICB, ORs (95% CIs) for apixaban versus warfarin were 0.67 (0.44–1.00) for appropriate dose and 0.45 (0.21–0.95) for inappropriate dose; for rivaroxaban versus warfarin, estimates were 0.81 (0.55–1.20) for appropriate dose and 1.14 (0.56–2.31) for inappropriate dose.Conclusions Dosing appropriateness in NVAF was not associated with a significant difference in IS/SE risk or increase in ICB risk versus warfarin. These findings may reflect residual confounding and biases that were difficult to control, as also seen in other observational studies. They should, therefore, be interpreted with caution, and prescribers should adhere to the dosing instructions in the respective Summary of Product Characteristics. Further studies on this topic from real-world populations are needed.https://bmjopen.bmj.com/content/12/6/e059311.full |
| spellingShingle | Luis Alberto García Rodríguez Pareen Vora Luke Roberts Gunnar Brobert Samuel Fatoba María Eugenia Sáez Antonio González-Pérez Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care BMJ Open |
| title | Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care |
| title_full | Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care |
| title_fullStr | Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care |
| title_full_unstemmed | Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care |
| title_short | Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case–control analyses from UK primary care |
| title_sort | safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation a cohort study with nested case control analyses from uk primary care |
| url | https://bmjopen.bmj.com/content/12/6/e059311.full |
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