Dataset Information

Relation of apixaban bleeding rates to dose in patients with chronic kidney disease.

ABSTRACT: The objective of this study was to evaluate the safety and efficacy of apixaban 5 mg twice daily vs 2.5 mg twice daily for nonvalvular atrial fibrillation or venous thromboembolism in patients with chronic kidney disease stage 4 and 5, including those on hemodialysis. Data were collected retrospectively on patients with advanced chronic kidney disease and nonvalvular atrial fibrillation and/or venous thromboembolism who received apixaban while hospitalized at our institution between January 2013 and August 2018. The 5 mg twice daily group included 22 patients, and the 2.5 mg twice daily group included 73 patients. There was no difference between groups in major bleeding events (9.1% vs. 12.3%, P = 1.00), any bleeding event (45.4% vs. 67.1%, P = 0.08), ischemic stroke (0% vs. 2.7%, P = 1.00), or venous thromboembolism (4.5% vs. 0%, P = 0.23). Subgroup analyses of patients with a serum creatinine >2.5 mg/dL or creatinine clearance <25 mL/min and patients on hemodialysis produced similar results. Until larger trials are conducted, clinicians should make patient-specific decisions about the optimal dose of apixaban in patients with severe renal impairment.

SUBMITTER: Yun S

PROVIDER: S-EPMC8366955 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Relation of apixaban bleeding rates to dose in patients with chronic kidney disease.

Yun Sarah S Sevinsky Regan R Spracklin Tasleem T Tatara Alexandra A Fenves Andrew Zoltan AZ

Proceedings (Baylor University. Medical Center) 20210604 5

The objective of this study was to evaluate the safety and efficacy of apixaban 5 mg twice daily vs 2.5 mg twice daily for nonvalvular atrial fibrillation or venous thromboembolism in patients with chronic kidney disease stage 4 and 5, including those on hemodialysis. Data were collected retrospectively on patients with advanced chronic kidney disease and nonvalvular atrial fibrillation and/or venous thromboembolism who received apixaban while hospitalized at our institution between January 2013 ...[more]

PMID: 34456472

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Project description:Introduction: Accumulation of apixaban in plasma is a major concern in patients with chronic kidney disease (CKD). Studies that investigated plasma apixaban level in CKD patients and its association with clinically significant events are scarce. Methods: Patients with CKD Stage 1-4 who were taking apixaban, either 2.5 mg BD or 5 mg BD were recruited. The peak and trough plasma apixaban level were measured after 2 h and 12 h of last dose respectively. The results were correlated with renal function and clinical events during the period of follow-up from 1 January 2018 to 31 October 2021. Results: 141 patients (CKD Stage 1, n = 12; Stage 2, n = 74; Stage 3, n = 48, stage 4, n = 7) were included for analysis. The plasma peak and trough apixaban were significantly higher in patients with CKD stage 3 when compared with those having CKD stage 2 and 1 (peak levels: 223.4 ± 107.8 ng/ml vs. 161.0 ± 55.2 ng/ml vs. 126.6 ± 30.2 ng/ml; trough levels: 118.3 ± 67.9 ng/ml vs. 81.2 ± 33.0 ng/ml vs. 51.9 ± 31.1 ng/ml, p < 0.05 or all) in patients taking 5 mg BD. Plasma trough apixaban level was negatively correlated with eGFR in patients taking 5 mg BD (r 2 = -0.174, p < 0.001) and 2.5 mg BD (r 2 = -0.215, p < 0.05). The plasma peak and trough apixaban level correlated with PT (r 2 = 0.065, p = 0.003 and r 2 = 0.096, p < 0.01 respectively). Multivariate analysis showed that plasma trough apixaban levels were associated with the risk of bleeding complications (Odd ratio: 1.011, 95% CI:1.002-1.021, p = 0.023). Conclusion: The plasma apixaban level shows a trend of increase with worsening renal function, and an increase in the plasma apixaban level is suggestive of an increased risk of bleeding complications in patients with CKD. Further large-scale prospective studies are needed to evaluate relationship between plasma apixaban level and renal function as well as safety outcome in CKD patients. Moreover, the role of drug level monitoring should be prospectively evaluated for dosage optimization and the minimization of bleeding risks in CKD patients.

Project description:BackgroundRecommendations for apixaban dosing on the basis of kidney function are inconsistent between the US Food and Drug Administration and European Medicines Agency for patients with atrial fibrillation. Optimal apixaban dosing in chronic kidney disease remains unknown.MethodsWith the use of deidentified electronic health record data from the Optum Labs Data Warehouse, patients with atrial fibrillation and chronic kidney disease stage 4/5 initiating apixaban between 2013 and 2021 were identified. Risks of bleeding and stroke/systemic embolism were compared by apixaban dose (5 versus 2.5 mg), adjusted for baseline characteristics by the inverse probability of treatment weighting. The Fine-Gray subdistribution hazard model was used to account for the competing risk of death. Cox regression was used to examine risk of death by apixaban dose.ResultsAmong 4313 apixaban new users, 1705 (40%) received 5 mg and 2608 (60%) received 2.5 mg. Patients treated with 5 mg apixaban were younger (mean age, 72 versus 80 years), with greater weight (95 versus 80 kg) and higher serum creatinine (2.7 versus 2.5 mg/dL). Mean estimated glomerular filtration rate was not different between the groups (24 versus 24 mL·min-1·1.73 m-2). In inverse probability of treatment weighting analysis, apixaban 5 mg was associated with a higher risk of bleeding (incidence rate 4.9 versus 2.9 events per 100 person-years; incidence rate difference, 2.0 [95% CI, 0.6-3.4] events per 100 person-years; subdistribution hazard ratio, 1.63 [95% CI, 1.04-2.54]). There was no difference between apixaban 5 mg and 2.5 mg groups in the risk of stroke/systemic embolism (3.3 versus 3.0 events per 100 person-years; incidence rate difference, 0.2 [95% CI, -1.0 to 1.4] events per 100 person-years; subdistribution hazard ratio, 1.01 [95% CI, 0.59-1.73]), or death (9.9 versus 9.4 events per 100 person-years; incidence rate difference, 0.5 [95% CI, -1.6 to 2.6] events per 100 person-years; hazard ratio, 1.03 [95% CI, 0.77-1.38]).ConclusionsCompared with 2.5 mg, use of 5 mg apixaban was associated with a higher risk of bleeding in patients with atrial fibrillation and severe chronic kidney disease, with no difference in the risk of stroke/systemic embolism or death, supporting the apixaban dosing recommendations on the basis of kidney function by the European Medicines Agency, which differ from those issued by the US Food and Drug Administration.

Dataset Information

Relation of apixaban bleeding rates to dose in patients with chronic kidney disease.

Publications

Relation of apixaban bleeding rates to dose in patients with chronic kidney disease.

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