A T Cohen1, N R Hill2, X Luo3, C Masseria3, S A Abariga4, A O Ashaye5. 1. Guy's and St. Thomas' Hospitals, King's College, London, UK. 2. Bristol-Myers Squibb Company, Lawrenceville, NJ, USA. 3. Pfizer, Inc., New York, NY, USA. 4. Evidera Inc., Waltham, MA, USA. 5. Evidera Inc., Waltham, MA, USA. Electronic address: ajibade_ashaye@yahoo.com.
Abstract
BACKGROUND: Direct oral anticoagulants (DOACs) are indicated for the prevention of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation. While no head-to-head randomized controlled trials (RCTs) exist that evaluate the efficacy and safety of DOACs, network meta-analyses (NMAs) based mainly on RCTs for each DOAC and using various methodologies have been published. This systematic literature review summarizes the evidence on stroke/SE bleeding events, mortality, and other adverse events from NMAs that reported indirect comparisons of DOACs. METHODS: Searches were conducted in PubMed, Embase, and the Cochrane Database of Systematic Reviews to identify NMAs published between January 2010 and March 2017 that compared vitamin K antagonists or DOACs using RCT data. Comparisons on stroke/SE and major bleeding (MB), as well as secondary outcomes, for DOAC versus DOAC comparisons were extracted and summarized using apixaban as the reference. RESULTS: Twenty-two NMAs were included in the final summary: All assessed MB; 15 assessed stroke/SE. No statistically significant differences were observed for apixaban compared with any DOAC in the 15 NMAs that assessed stroke/SE. Apixaban was associated with a lower risk for MB compared with rivaroxaban in 16 of 20 NMAs and dabigatran 150 mg in 13 of 16 NMAs. Four of 6 NMAs showed lower risk for GI bleeding for apixaban compared with rivaroxaban and dabigatran 150 mg; however, this outcome was not assessed by most NMAs. CONCLUSION: This systematic literature review of NMAs showed varying levels of bleeding risk among DOACs, with apixaban generally having a lower risk than rivaroxaban and dabigatran 150 mg.
BACKGROUND: Direct oral anticoagulants (DOACs) are indicated for the prevention of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation. While no head-to-head randomized controlled trials (RCTs) exist that evaluate the efficacy and safety of DOACs, network meta-analyses (NMAs) based mainly on RCTs for each DOAC and using various methodologies have been published. This systematic literature review summarizes the evidence on stroke/SE bleeding events, mortality, and other adverse events from NMAs that reported indirect comparisons of DOACs. METHODS: Searches were conducted in PubMed, Embase, and the Cochrane Database of Systematic Reviews to identify NMAs published between January 2010 and March 2017 that compared vitamin K antagonists or DOACs using RCT data. Comparisons on stroke/SE and major bleeding (MB), as well as secondary outcomes, for DOAC versus DOAC comparisons were extracted and summarized using apixaban as the reference. RESULTS: Twenty-two NMAs were included in the final summary: All assessed MB; 15 assessed stroke/SE. No statistically significant differences were observed for apixaban compared with any DOAC in the 15 NMAs that assessed stroke/SE. Apixaban was associated with a lower risk for MB compared with rivaroxaban in 16 of 20 NMAs and dabigatran 150 mg in 13 of 16 NMAs. Four of 6 NMAs showed lower risk for GI bleeding for apixaban compared with rivaroxaban and dabigatran 150 mg; however, this outcome was not assessed by most NMAs. CONCLUSION: This systematic literature review of NMAs showed varying levels of bleeding risk among DOACs, with apixaban generally having a lower risk than rivaroxaban and dabigatran 150 mg.
Authors: Antonios Douros; Madeleine Durand; Carla M Doyle; Sarah Yoon; Pauline Reynier; Kristian B Filion Journal: Drug Saf Date: 2019-10 Impact factor: 5.606
Authors: Steven Deitelzweig; Christine L Baker; Amol D Dhamane; Jack Mardekian; Oluwaseyi Dina; Lisa Rosenblatt; Cristina Russ; Tayla Poretta; Melissa Lingohr-Smith; Jay Lin Journal: J Drug Assess Date: 2020-04-24
Authors: Davide Capodanno; Marco Di Maio; Antonio Greco; Deepak L Bhatt; C Michael Gibson; Andreas Goette; Renato D Lopes; Roxana Mehran; Pascal Vranckx; Dominick J Angiolillo Journal: J Am Heart Assoc Date: 2020-08-01 Impact factor: 5.501