Dabigatran and Kidney Disease

Knauf, Felix; Chaknos, C. Michael; Berns, Jeffrey S.; Perazella, Mark A.

doi:10.2215/cjn.01260213

Cited by 33 publications

(32 citation statements)

References 39 publications

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“…13 Patients on dabigatran (dialyzable) who achieved less urea clearance (< 230 cc/min) had more major bleeding than patients whose urea clearance was ≥230 cc/min (Figure 2). The amount of dialysis urea clearance did not decrease the risk of bleeding with rivaroxaban likely because the drug is not affected by dialysis.…”

Section: Resultsmentioning

confidence: 99%

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Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis

et al. 2015

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Background Dabigatran and rivaroxaban are new oral anticoagulants that are eliminated through the kidneys. Their use in dialysis patients is discouraged because these drugs can bio-accumulate to precipitate inadvertent bleeding. We wanted to determine if prescription of dabigatran or rivaroxaban was occurring in the dialysis population and if these practices were safe. Methods and Results Prevalence plots were used to describe the point prevalence (monthly) of dabigatran and rivaroxaban use among 29,977 hemodialysis patients with atrial fibrillation (AF). Poisson regression compared the rate of bleeding, stroke, and arterial embolism in patients who started dabigatran, rivaroxaban, or warfarin. The first record of dabigatran prescription among hemodialysis patients occurred 45 days after the drug became available in the US. Since then, dabigatran and rivaroxaban use in the AF-ESRD population has steadily risen where 5.9% of anti-coagulated dialysis patients are started on dabigatrian or rivaroxaban. In covariate adjusted Poisson regression, dabigatran (RR=1.48; 95% CI 1.21-1.81, p=0.0001) and rivaroxaban (RR=1.38; 95% CI 1.03-1.83, p=0.04) associated with a higher risk of hospitalization or death from bleeding when compared to warfarin. The risk of hemorrhagic death was even larger with dabigatran (RR=1.78; 95% CI 1.18-2.68, p=0.006) and rivaroxaban (RR=1.71; 95% CI 0.94-3.12, p=0.07) relative to warfarin. There were too few events in the study to detect meaningful differences in stroke and arterial embolism between the drug groups. Conclusions More dialysis patients are being started on dabigatran and rivaroxaban, even when their use is contraindicated and there are no studies to support the benefits outweigh the risks of these drugs in ESRD.

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Section: Resultsmentioning

confidence: 99%

“…The half-life of the drug is 9 hours, but increases to 25-30 hours in individuals with a creatinine clearance <30 cc/min. 13 …”

Section: Discussionmentioning

confidence: 99%

Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis

et al. 2015

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“…The patients studied in the RE‐VERSE AD trial had a median creatinine clearance of 58 ml/minute . The half‐life of dabigatran is elevated in patients with renal impairment, and in patients with a creatinine clearance of 15–30 ml/minute, the half‐life is increased to approximately 25–30 hours . In additional data submitted to the FDA from the RE‐VERSE AD trial, two of 90 patients required administration of an additional 5‐g dose within 24 hours of the initial dose due to elevation of coagulation parameters and rebleeding…”

Section: Discussionmentioning

confidence: 99%

Management of Dabigatran‐Associated Bleeding with Two Doses of Idarucizumab Plus Hemodialysis

et al. 2016

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Vitamin K antagonists have been a mainstay of treatment for patients requiring anticoagulation for atrial fibrillation, but direct oral anticoagulants, such as dabigatran, have become increasingly prescribed. Compared with warfarin, dabigatran has a significantly lower risk of life-threatening bleeding; however, bleeding events can still occur, supporting the need for effective reversal strategies. Idarucizumab was recently approved by the U.S. Food and Drug Administration to reverse the anticoagulant effects of dabigatran when life-threatening bleeding occurs or an urgent need for an invasive medical procedure exists. Before idarucizumab's approval, reversal strategies included hemodialysis, coagulation factor replacement, and, in the setting of acute ingestion, activated charcoal. We describe the case of a 58-year-old, obese woman with a history of atrial fibrillation who developed acute kidney injury while taking dabigatran 150 mg twice/day, resulting in coagulopathy. Despite receiving idarucizumab 5 g and hemodialysis, there was a rebound increase in prothrombin time (PT) and activated partial thromboplastin time (aPTT) values, prompting administration of an additional 5-g dose of idarucizumab and continued hemodialysis, with subsequent PT and aPTT values remaining within their appropriate ranges. To our knowledge, this is the first case report to describe the successful use of repeat dosing of idarucizumab with hemodialysis to reverse the anticoagulant effects of dabigatran. Although two doses of idarucizumab were given to our patient, this dosing regimen is not the current standard of practice. Administration of idarucizumab and the use of additional reversal strategies should involve an assessment of each individual patient's severity of bleeding and subsequent risk of thrombosis. Due to the recent availability of idarucizumab and varying success with alternative reversal strategies, additional knowledge is needed for the optimal reversal of anticoagulation from dabigatran.

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“…The half-life of the drug increases from 9 hours with normal renal function to 25-30 hours in patients with creatinine clearance <30mL/min (47). It is dialysable, with 50-60% of the drug removed after a 4 hours of haemodialysis (48).…”

Section: Use Of Newer Anticoagulantsmentioning

confidence: 99%

Anticoagulation for Atrial Fibrillation in End-stage Kidney Disease

Lee¹,

Johnson²

2015

jcbmr

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Atrial fibrillation (AF) is the most common arrhythmia in the general population and it has been found to have a higher prevalence in end-stage kidney disease (ESKD). It is associated with a higher risk of stroke and mortality compared to those without AF. Patients with ESKD have generally been excluded from randomized controlled trials (RCTs) evaluating the efficacy of anticoagulation in reduction of stroke risk. Current observational evidence for anticoagulation for AF in the ESKD population has yielded conflicting results, but in aggregate favours a lack of benefit in stroke risk reduction with an increase in bleeding risk. There are also reports that warfarin use in ESKD patients on dialysis is associated with greater International Normalised Ratio (INR) variability and increased risk of vascular calcification and calciphylaxis (uraemic calcific arteriolopathy). RCTs are required to assess the net clinical benefit of anticoagulation in this group.

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Dabigatran and Kidney Disease

Cited by 33 publications

References 39 publications

Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis

Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis

Management of Dabigatran‐Associated Bleeding with Two Doses of Idarucizumab Plus Hemodialysis

Anticoagulation for Atrial Fibrillation in End-stage Kidney Disease

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