Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin

Lindner, Samuel M.; Fordyce, Christopher B.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Piccini, Jonathan P.; Breithardt, Günter; Mahaffey, Kenneth W.; Singer, Daniel E.; Hacke, Werner; Halperin, Jonathan L.; Hankey, Graeme J.; Berkowitz, Scott D.; Nessel, Christopher C.; Becker, Richard C.; Fox, Keith A.A.; Patel, Manesh R.

doi:10.1161/circulationaha.116.024666

Cited by 31 publications

(16 citation statements)

References 5 publications

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“…Consistent with the overall ROCKET‐AF trial results, rivaroxaban remains noninferior to warfarin for the principle efficacy end point across the full range of baseline CrCl included in the trial. Last, similar rates of the principle safety end point were observed across all renal function subgroups 28 …”

Section: Resultsmentioning

confidence: 55%

“…A final ad hoc analysis of the different baseline renal populations in the ROCKET‐AF trial was conducted by Lindner et al 28 . This analysis examined the primary efficacy and safety end points within patients now grouped by 4 different renal function/CrCl categories: moderate renal impairment, CrCl 30 to <50 mL/min; mild renal impairment, CrCl 50 to <80 mL/min; normal renal function, ≥80 mL/min; and high CrCl, CrCl > 95 mL/min) 28 . As expected, the rates of the primary efficacy end point increased with declining CrCl, regardless of treatment.…”

Section: Resultsmentioning

confidence: 99%

“… 28 This analysis examined the primary efficacy and safety end points within patients now grouped by 4 different renal function/CrCl categories: moderate renal impairment, CrCl 30 to <50 mL/min; mild renal impairment, CrCl 50 to <80 mL/min; normal renal function, ≥80 mL/min; and high CrCl, CrCl > 95 mL/min). 28 As expected, the rates of the primary efficacy end point increased with declining CrCl, regardless of treatment. Similarly, the rates of the primary safety end point also increased with declining CrCl, again regardless of treatment.…”

Section: Resultsmentioning

confidence: 99%

“…No differences were observed between treatment arms, except a significantly lower risk of major bleeding was observed in the CrCl ≥ 80 mL/min normal renal function group treated with warfarin versus rivaroxaban (2.34 vs 3.10 events per 100 patient‐years). 28 …”

Section: Resultsmentioning

confidence: 99%

“…Last, similar rates of the principle safety end point were observed across all renal function subgroups. 28 …”

Section: Resultsmentioning

confidence: 99%

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The Pharmacology, Efficacy, and Safety of Rivaroxaban in Renally Impaired Patient Populations

Ashton

Kerolus-Georgi

Moore

2021

The Journal of Clinical Pharma

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Rivaroxaban is a factor-Xa inhibitor oral anticoagulant first approved for use in the United States in 2011. Under the drug class commonly termed Direct Oral Anticoagulants, rivaroxaban is approved for 7 indications, the most within its class, which include: (1) Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation; (2) Treatment of Deep Vein Thrombosis (DVT); (3) Treatment of Pulmonary Embolism (PE); (4) Reduction in the risk of recurrence of DVT and/or PE; (5) Prophylaxis of DVT following hip or knee replacement surgery; (6) Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding; and (7) Reduction of risk of major cardiovascular events in patients with chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD). Considering the relationship between cardiovascular disease, renal impairment and the use of oral anticoagulants, the following targeted review was created. This review reports the results of the primary pharmacology, pharmacokinetic modeling, clinical safety and efficacy, and real-world post-marketing effectiveness and safety of rivaroxaban in patients with various degrees of renal impairment. Based on this data, rivaroxaban is a viable option for when anticoagulation is needed in patients that have both cardiovascular disease and renal impairment. However, as with any therapy, the benefits and risks of intervention should be carefully assessed and balanced. Patients treated with rivaroxaban for several of its approved indications should have their kidney function assessed, prior to and during continued therapy, to ensure consistency with the drug label.

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Section: Resultsmentioning

confidence: 55%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Last, similar rates of the principle safety end point were observed across all renal function subgroups. 28 …”

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

The Pharmacology, Efficacy, and Safety of Rivaroxaban in Renally Impaired Patient Populations

Ashton

Kerolus-Georgi

Moore

2021

The Journal of Clinical Pharma

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Prescription of DOACs in Patients with Atrial Fibrillation at Different Stages of Renal Insufficiency

Hahn,

Lamparter

2023

Adv Ther

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Atrial fibrillation (AF) and renal insufficiency often coexist and are increasingly prevalent with advancing age. Both the risk of thromboembolic events and bleeding propensity are higher in patients with AF and impaired renal function versus those with good renal health. Direct oral anticoagulants (DOACs) are being increasingly preferred over vitamin K antagonists (VKAs) in the treatment of patients with AF and impaired renal function as VKAs may accelerate progression of chronic kidney disease. DOACs, however, are eliminated by the kidneys to varying degrees, and their dosages must be adapted in accordance with renal function. Since creatinine clearance (CrCl) monitoring is recommended in patients with AF receiving DOAC therapy, CrCl must be routinely monitored in patients at the start and during the course of anticoagulation to avoid deviation from Summary of Product Characteristics dosage specifications. This review article provides an overview of current knowledge on the selection and dose of DOACs including apixaban, dabigatran, edoxaban and rivaroxaban in AF patients at different stages of renal insufficiency, with a special focus on elderly patients with comorbidities and receiving multiple medications. The groups discussed in this review include patients with varying levels of CrCl including hyperfiltration or CrCl > 90 ml/min, CrCl < 90–50 ml/min, CrCl < 50–30 ml/min, CrCl < 30–15 ml/min and end-stage renal disease or on dialysis.

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Edoxaban and the Issue of Drug-Drug Interactions: From Pharmacology to Clinical Practice

Corsini

Ferri

Proietti

et al. 2020

Drugs

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Edoxaban, a direct factor Xa inhibitor, is the latest non-vitamin K antagonist oral anticoagulants (NOACs). Despite being marketed later than other NOACs, its use is now spreading in current clinical practice, being indicated for both thromboprophylaxis in patients with non-valvular atrial fibrillation (NVAF) and for the treatment and prevention of venous thromboembolism (VTE). In patients with multiple conditions, the contemporary administration of several drugs can cause relevant drug-drug interactions (DDIs), which can affect drugs' pharmacokinetics and pharmacodynamics. Usually, all the NOACs are considered to have significantly fewer DDIs than vitamin K antagonists; notwithstanding, this is actually not true, all of them are affected by DDIs with drugs that can influence the activity (induction or inhibition) of P-glycoprotein (P-gp) and cytochrome P450 3A4, both responsible for NOACs disposition and metabolism to a different extent. In this review/expert opinion, we focused on an extensive report of edoxaban DDIs. All the relevant drugs categories have been examined to report on significant DDIs, discussing the impact on edoxaban pharmacokinetic and pharmacodynamic and the evidence for dose adjustment. Our analysis found that, despite a restrained number of interactions, some strong inhibitors/inducers of P-gp and drug-metabolising enzymes can affect edoxaban concentration, just as it happens with other NOACs, implying the need for a dose adjustment. However, our analysis of edoxaban DDIs suggests that given the small propensity for interaction of this agent, its use represents an acceptable clinical decision. Still, DDIs can be significant in certain clinical situations and a careful evaluation is always needed when prescribing NOACs.

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Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin

Cited by 31 publications

References 5 publications

The Pharmacology, Efficacy, and Safety of Rivaroxaban in Renally Impaired Patient Populations

The Pharmacology, Efficacy, and Safety of Rivaroxaban in Renally Impaired Patient Populations

Prescription of DOACs in Patients with Atrial Fibrillation at Different Stages of Renal Insufficiency

Edoxaban and the Issue of Drug-Drug Interactions: From Pharmacology to Clinical Practice

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