Dose-Finding Study of Rivaroxaban in Hemodialysis Patients

Vriese, An S. De; Caluwé, Rogier; Bailleul, Els; Bacquer, Dirk De; Borrey, Daniëlle; Vlem, Bruno Van; Vandecasteele, Stefaan; Emmerechts, Jan

doi:10.1053/j.ajkd.2015.01.022

Cited by 130 publications

(110 citation statements)

References 22 publications

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“…A PK/PD study extended this finding by reporting similar AUCs (plasma concentration-time curve) in patients with ESKD and a 10-mg dose and healthy controls with a 20-mg dose (45). However, other controlled PK/PD studies challenged these findings and reported a 56% increase in AUC in patients with ESKD after a 15-mg dose administered postdialysis (46).…”

Section: Pharmacology In Kidney Diseasementioning

confidence: 83%

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease

Jain¹,

Reilly²

2018

CJASN

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Oral anticoagulants are commonly used drugs in patients with CKD and patients with ESKD to treat atrial fibrillation to reduce stroke and systemic embolism. Some of these drugs are used to treat or prevent deep venous thrombosis and pulmonary embolism in patients with CKD who undergo knee and hip replacement surgeries. Warfarin is the only anticoagulant that is approved for use by the Food and Drug Administration in individuals with mechanical heart valves. Each oral anticoagulant affects the coagulation profile in the laboratory uniquely. Warfarin and apixaban are the only anticoagulants that are Food and Drug Administration approved for use in patients with CKD and patients with ESKD. However, other oral anticoagulants are commonly used off label in this patient population. Given the acquired risk of bleeding from uremia, these drugs are known to cause increased bleeding events, hospitalization, and overall morbidity. Each anticoagulant has unique pharmacologic properties of which nephrologists need to be aware to optimally manage patients. In addition, nephrologists are increasingly asked to aid in the management of adverse bleeding events related to oral anticoagulant use in patients with CKD and patients with ESKD. This article summarizes the clinical pharmacology of these drugs and identifies knowledge gaps in the literature related to their use.

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Section: Pharmacology In Kidney Diseasementioning

confidence: 83%

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease

Jain¹,

Reilly²

2018

CJASN

View full text Add to dashboard Cite

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“…Another study showed similar drug levels in 18 hemodialysis patients taking 10 mg/day of rivaroxaban compared to healthy volunteers taking 20 mg/day. There was, however accumulation of the drug after a few days despite receiving hemodialysis which had no effect on plasma concentrations of the drug [31]. Given its high rate of renal elimination, dabigatran accumulates when administered to patients with ESRD [32]; however, it is the only of the 4 NOACs that is quickly eliminated by hemodialysis because of its low rate of binding to plasma proteins.…”

Section: Novel Oral Anticoagulants and Ckdmentioning

confidence: 99%

“…A reduced dose of 5 mg/day is only indicated with the presence of 1 of the following clinical characteristics: age ≥80 years or weight ≤60 kg. Moreover, recently FDA stated that administration of rivaroxaban 15 mg once daily will result in concentrations and pharmacodynamic activity similar to those observed in the ROCKET AF study [31]. However, clinical efficacy and safety studies with apixaban and rivaroxaban did not enroll patients with ESRD on dialysis or patients with a CrCl <15 mL/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-FXa activity) data in subjects with ESRD maintained on dialysis.…”

Section: Novel Oral Anticoagulants and Ckdmentioning

confidence: 99%

Recent Advances in Stroke Prevention in Patients with Atrial Fibrillation and End-Stage Renal Disease

Ronco¹,

Mazzone

Hosseinian

et al. 2017

Cardiorenal Med

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Background: Chronic kidney disease (CKD) is associated with a high prevalence of atrial fibrillation (AF), but in this population the risk/benefit ratio of anticoagulant therapy with vitamin K antagonists (VKA) for thromboprophylaxis is uncertain. Summary: In end-stage renal disease (ESRD) patients undergoing hemodialysis, VKA seem less effective in stroke prevention than in the general population, with an increased risk of major bleeding. Recently, novel oral anticoagulant agents (NOACs) have proven to be effective for stroke prevention in AF and have demonstrated an improved safety profile compared to VKA. Limited data from post hoc analyses of controlled clinical trials suggest the safe and effective use of NOACs in patients with moderate renal impairment (i.e., estimated glomerular filtration rate, eGFR, between 30 and 50 mL/min). The question still remains whether NOACs can be used in patients with an eGFR <30 mL/min, since there are no studies addressing this subject. In fact, patients with CKD stage 4 and 5 were excluded from controlled clinical trials on anticoagulation therapy for stroke prevention in AF. Left atrial appendage (LAA) occlusion represents a nonpharmacological alternative for stroke prevention in patients with AF who are difficult to manage medically. Preliminary data indicate a similar efficacy and safety profile in patients with CKD compared to patients with normal renal function. Key Messages: Stroke prevention in patients with ESRD and AF represents a clinical challenge with poor evidence. LAA occlusion may become the standard of care for stroke prevention in patients with ESRD and AF.

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“…Allo stato attuale rivaroxaban non è raccomandato nei pazienti affetti da ESRD (eGFR <15 mL/min) o sottoposti a trattamento emodialitico, dal momento che, anche in questo caso, vi è una rimozione piuttosto modesta della molecola attraverso le membrane di dialisi (41).…”

Section: Rivaroxabanunclassified

Non-vitamin-K-dependent Oral Anticoagulants in End-stage Renal Disease Patients with Non-valvular Atrial Fibrillation: An Impossible Wedding?

Lullo¹,

Floccari

Rivera

et al. 2017

Giornale di Tecniche Nefrologiche e Dialitiche

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Atrial fibrillation (AF) is the most common arrhythmia in patients with chronic kidney disease (CKD). In this population, AF is associated with an increased risk of thromboembolism and stroke as a result of a progressive decline in the glomerular filtration rate. However, CKD patients, in particular those on renal replacement therapy, also have an increased risk of bleeding, especially from the gastrointestinal tract. Oral anticoagulation is the most effective form of thromboprophylaxis in patients with AF presenting an increased risk of stroke. Limited evidence of its efficacy, the increased risk of bleeding as well as some concern regarding the use of warfarin in CKD have often resulted in the underuse of anticoagulation in CKD patients. A large body of evidence suggests that non-vitamin-K-dependent oral anticoagulants (NOACs) significantly reduce the risk of stroke, intracranial hemorrhage and mortality. Hence, they are currently recommended for patients with AF at risk of stroke. However, the metabolism of NOACs is largely dependent on the kidneys for elimination and little is known about their use in patients with creatinine clearance <25 mL/min, who have been excluded from all pivotal phase III NOAC trials. This review focuses on the current pharmacokinetic, observational and prospective data on NOACs in patients affected by moderate to advanced CKD (creatinine clearance 15–49 mL/min) and in those on dialysis.

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Dose-Finding Study of Rivaroxaban in Hemodialysis Patients

Cited by 130 publications

References 22 publications

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease

Recent Advances in Stroke Prevention in Patients with Atrial Fibrillation and End-Stage Renal Disease

Non-vitamin-K-dependent Oral Anticoagulants in End-stage Renal Disease Patients with Non-valvular Atrial Fibrillation: An Impossible Wedding?

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