Safety and efficacy of apixaban versus warfarin in patients with end‐stage renal disease: Meta‐analysis

Background At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine clearance <15 mL/min or end‐stage renal disease (ESRD). However, the recommendations are based on pharmacokinetic and pharmacodynamic...

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Published inPacing and clinical electrophysiology Vol. 41; no. 6; pp. 627 - 634
Main Authors Chokesuwattanaskul, Ronpichai, Thongprayoon, Charat, Tanawuttiwat, Tanyanan, Kaewput, Wisit, Pachariyanon, Pavida, Cheungpasitporn, Wisit
Format Journal Article
LanguageEnglish
Published United States Wiley Subscription Services, Inc 01.06.2018
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Abstract Background At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine clearance <15 mL/min or end‐stage renal disease (ESRD). However, the recommendations are based on pharmacokinetic and pharmacodynamic data and there was lack of clinical trial evidence. We aimed to assess safety and efficacy of apixaban in patients with advanced chronic kidney disease (CKD) or ESRD. Methods Databases were searched through November 2017. Studies that reported incidence or odd ratios of bleeding complications or thromboembolic events in the use of apixaban in patients with CKD stage 4–5 or ESRD on dialysis were included. Effect estimates from the individual study were extracted and combined using random‐effect, generic inverse variance method of DerSimonian and Laird. Results Five studies were included into the analysis consisting of 43,850 patients in observational cohort studies. The majority of patients (87%) used apixaban for atrial fibrillation. The pooled estimated incidence of any bleeding complications on apixaban was 17.4% (95% confidence interval [CI]: 13.0%–23.0%). Compared to warfarin, apixaban was significantly associated with reduced risk of major bleeding (pooled odds ratio [OR], 0.42; 95% CI, 0.28–0.61). In studies in ESRD patients on dialysis, the pooled OR of major bleeding was 0.27 (95% CI, 0.07–0.95). There was no significant difference in risk of thromboembolic events in advanced CKD or ESRD patients on apixaban versus vitamin K antagonists (pooled OR, 0.56; 95% CI, 0.23–1.39). Conclusions Among patients with advanced CKD and ESRD, the use of apixaban was associated with lower risk of major bleeding compared to warfarin, and was found to be relatively effective with no excess risk of thromboembolic events.
AbstractList BackgroundAt the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine clearance <15 mL/min or end‐stage renal disease (ESRD). However, the recommendations are based on pharmacokinetic and pharmacodynamic data and there was lack of clinical trial evidence. We aimed to assess safety and efficacy of apixaban in patients with advanced chronic kidney disease (CKD) or ESRD.MethodsDatabases were searched through November 2017. Studies that reported incidence or odd ratios of bleeding complications or thromboembolic events in the use of apixaban in patients with CKD stage 4–5 or ESRD on dialysis were included. Effect estimates from the individual study were extracted and combined using random‐effect, generic inverse variance method of DerSimonian and Laird.ResultsFive studies were included into the analysis consisting of 43,850 patients in observational cohort studies. The majority of patients (87%) used apixaban for atrial fibrillation. The pooled estimated incidence of any bleeding complications on apixaban was 17.4% (95% confidence interval [CI]: 13.0%–23.0%). Compared to warfarin, apixaban was significantly associated with reduced risk of major bleeding (pooled odds ratio [OR], 0.42; 95% CI, 0.28–0.61). In studies in ESRD patients on dialysis, the pooled OR of major bleeding was 0.27 (95% CI, 0.07–0.95). There was no significant difference in risk of thromboembolic events in advanced CKD or ESRD patients on apixaban versus vitamin K antagonists (pooled OR, 0.56; 95% CI, 0.23–1.39).ConclusionsAmong patients with advanced CKD and ESRD, the use of apixaban was associated with lower risk of major bleeding compared to warfarin, and was found to be relatively effective with no excess risk of thromboembolic events.
At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine clearance <15 mL/min or end-stage renal disease (ESRD). However, the recommendations are based on pharmacokinetic and pharmacodynamic data and there was lack of clinical trial evidence. We aimed to assess safety and efficacy of apixaban in patients with advanced chronic kidney disease (CKD) or ESRD. Databases were searched through November 2017. Studies that reported incidence or odd ratios of bleeding complications or thromboembolic events in the use of apixaban in patients with CKD stage 4-5 or ESRD on dialysis were included. Effect estimates from the individual study were extracted and combined using random-effect, generic inverse variance method of DerSimonian and Laird. Five studies were included into the analysis consisting of 43,850 patients in observational cohort studies. The majority of patients (87%) used apixaban for atrial fibrillation. The pooled estimated incidence of any bleeding complications on apixaban was 17.4% (95% confidence interval [CI]: 13.0%-23.0%). Compared to warfarin, apixaban was significantly associated with reduced risk of major bleeding (pooled odds ratio [OR], 0.42; 95% CI, 0.28-0.61). In studies in ESRD patients on dialysis, the pooled OR of major bleeding was 0.27 (95% CI, 0.07-0.95). There was no significant difference in risk of thromboembolic events in advanced CKD or ESRD patients on apixaban versus vitamin K antagonists (pooled OR, 0.56; 95% CI, 0.23-1.39). Among patients with advanced CKD and ESRD, the use of apixaban was associated with lower risk of major bleeding compared to warfarin, and was found to be relatively effective with no excess risk of thromboembolic events.
Background At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine clearance <15 mL/min or end‐stage renal disease (ESRD). However, the recommendations are based on pharmacokinetic and pharmacodynamic data and there was lack of clinical trial evidence. We aimed to assess safety and efficacy of apixaban in patients with advanced chronic kidney disease (CKD) or ESRD. Methods Databases were searched through November 2017. Studies that reported incidence or odd ratios of bleeding complications or thromboembolic events in the use of apixaban in patients with CKD stage 4–5 or ESRD on dialysis were included. Effect estimates from the individual study were extracted and combined using random‐effect, generic inverse variance method of DerSimonian and Laird. Results Five studies were included into the analysis consisting of 43,850 patients in observational cohort studies. The majority of patients (87%) used apixaban for atrial fibrillation. The pooled estimated incidence of any bleeding complications on apixaban was 17.4% (95% confidence interval [CI]: 13.0%–23.0%). Compared to warfarin, apixaban was significantly associated with reduced risk of major bleeding (pooled odds ratio [OR], 0.42; 95% CI, 0.28–0.61). In studies in ESRD patients on dialysis, the pooled OR of major bleeding was 0.27 (95% CI, 0.07–0.95). There was no significant difference in risk of thromboembolic events in advanced CKD or ESRD patients on apixaban versus vitamin K antagonists (pooled OR, 0.56; 95% CI, 0.23–1.39). Conclusions Among patients with advanced CKD and ESRD, the use of apixaban was associated with lower risk of major bleeding compared to warfarin, and was found to be relatively effective with no excess risk of thromboembolic events.
Abstract Background At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine clearance <15 mL/min or end‐stage renal disease (ESRD). However, the recommendations are based on pharmacokinetic and pharmacodynamic data and there was lack of clinical trial evidence. We aimed to assess safety and efficacy of apixaban in patients with advanced chronic kidney disease (CKD) or ESRD. Methods Databases were searched through November 2017. Studies that reported incidence or odd ratios of bleeding complications or thromboembolic events in the use of apixaban in patients with CKD stage 4–5 or ESRD on dialysis were included. Effect estimates from the individual study were extracted and combined using random‐effect, generic inverse variance method of DerSimonian and Laird. Results Five studies were included into the analysis consisting of 43,850 patients in observational cohort studies. The majority of patients (87%) used apixaban for atrial fibrillation. The pooled estimated incidence of any bleeding complications on apixaban was 17.4% (95% confidence interval [CI]: 13.0%–23.0%). Compared to warfarin, apixaban was significantly associated with reduced risk of major bleeding (pooled odds ratio [OR], 0.42; 95% CI, 0.28–0.61). In studies in ESRD patients on dialysis, the pooled OR of major bleeding was 0.27 (95% CI, 0.07–0.95). There was no significant difference in risk of thromboembolic events in advanced CKD or ESRD patients on apixaban versus vitamin K antagonists (pooled OR, 0.56; 95% CI, 0.23–1.39). Conclusions Among patients with advanced CKD and ESRD, the use of apixaban was associated with lower risk of major bleeding compared to warfarin, and was found to be relatively effective with no excess risk of thromboembolic events.
Author Cheungpasitporn, Wisit
Chokesuwattanaskul, Ronpichai
Tanawuttiwat, Tanyanan
Thongprayoon, Charat
Pachariyanon, Pavida
Kaewput, Wisit
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  organization: University of Mississippi Medical Center
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Keywords atrial fibrillation
thromboembolic events
meta-analysis
bleeding complication
apixaban
vitamin K antagonist
warfarin
Language English
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Ronpichai Chokesuwattanaskul and Charat Thongprayoon are co‐first authors.
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Snippet Background At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with...
At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with creatinine...
Abstract Background At the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients...
BackgroundAt the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with...
BACKGROUNDAt the present, apixaban is the only nonvitamin K oral anticoagulant approved by the Food and Drug Administration for use with patients with...
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SubjectTerms Antagonists
Anticoagulants
Anticoagulants - adverse effects
Anticoagulants - pharmacology
apixaban
atrial fibrillation
Bleeding
bleeding complication
Cardiac arrhythmia
Creatinine
Dialysis
Fibrillation
Health risk assessment
Humans
Kidney diseases
Kidney Failure, Chronic - complications
Meta-analysis
Pharmacodynamics
Pyrazoles - adverse effects
Pyrazoles - pharmacology
Pyridones - adverse effects
Pyridones - pharmacology
thromboembolic events
Thromboembolism
Thromboembolism - etiology
Thromboembolism - prevention & control
Thrombosis - etiology
Thrombosis - prevention & control
Vitamin K
vitamin K antagonist
Warfarin
Warfarin - adverse effects
Warfarin - pharmacology
Title Safety and efficacy of apixaban versus warfarin in patients with end‐stage renal disease: Meta‐analysis
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fpace.13331
https://www.ncbi.nlm.nih.gov/pubmed/29577340
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Volume 41
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