Underuse of Full Dose Factor Xa Inhibition in Atrial Fibrillation: Insight From the Sprint-Af Registry

Gupta, Milan; Singh, Narendra; Tsigoulis, Michelle; Kajil, Mahesh; Cox, Jafna L.; Dorian, Paul; Mancini, G.B. John; Ha, Andrew C.T.

doi:10.1016/s0735-1097(15)60348-5

Cited by 5 publications

(7 citation statements)

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“…This analysis suggested that more patients are being prescribed a reduced dose of the Factor Xa inhibitors than those who met eligibility criteria as defined in the phase III clinical trials. 45 It is possible these results reflect dosing decisions based on other clinical considerations, where patients with a higher comorbid burden, who are more likely to have worse outcomes, may be receiving the lower dose even if they do not meet the recommended dosing criteria. Recent real-world evidence reported on outcomes in patients receiving lower doses of the NOACs without a ‘renal indication’ for dose reduction.…”

Section: Clinical Considerationsmentioning

confidence: 93%

“…Emerging real-world evidence and global prescription data suggest patients with AF are not being dosed appropriately. 45 , 46 An analysis of the SPRINT AF registry assessed the prevalence of Canadian patients eligible for the reduced dose of apixaban or rivaroxaban. This analysis suggested that more patients are being prescribed a reduced dose of the Factor Xa inhibitors than those who met eligibility criteria as defined in the phase III clinical trials.…”

Section: Clinical Considerationsmentioning

confidence: 99%

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Nonvitamin K antagonist oral anticoagulant use in patients with renal impairment

Turpie

Purdham

Ciaccia

2017

Therapeutic Advances in Cardiovascular Disease

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The nonvitamin K antagonist oral anticoagulants (NOACs), also referred to as direct oral anticoagulants (DOACs), dabigatran, apixaban, edoxaban, and rivaroxaban, have emerged as effective alternatives to vitamin K antagonists (VKAs) across several indications, including the prevention of stroke and systemic embolism (SSE) in patients with atrial fibrillation (AF) and the treatment of venous thromboembolism (VTE). Their use in patients with renal impairment is of particular importance, given the prevalence of renal dysfunction in the indicated populations and the impact of renal function on the metabolism of the NOACs. This publication reviews the pharmacokinetic/pharmacodynamic properties of the NOACs and clinical trial results for patients with renal impairment within the AF and VTE indications. Pharmacokinetic/pharmacodynamic data show the NOACs are dependent on renal clearance to varying extents. Relative to VKAs, the efficacy and safety of the NOACs is preserved in patients with moderate renal impairment. The dosing recommendations for patients with renal impairment differ depending on the NOAC, whereby some of the NOACs require dose reductions based solely on renal function, while others require consideration of additional criteria. However, despite these specific dosing recommendations, emerging real-world evidence suggests patients are not being dosed appropriately, indicating a possible knowledge gap. Adherence to recommended dosing algorithms has implications on the optimal efficacy and safety of the NOACs. To this end, renal function should be assessed in patients on a NOAC, as worsening of renal function may warrant change in the dose of a NOAC or change in oral anticoagulant.

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Section: Clinical Considerationsmentioning

confidence: 93%

Section: Clinical Considerationsmentioning

confidence: 99%

Nonvitamin K antagonist oral anticoagulant use in patients with renal impairment

Turpie

Purdham

Ciaccia

2017

Therapeutic Advances in Cardiovascular Disease

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“…Dose reductions were mandated predominantly based on renal function (and also on other characteristics) in the phase III trials. Emerging real‐world data suggest patients prescribed DOACs are not being dosed as defined in the clinical trials (Gupta et al , ; Weitz & Eikelboom, ) . An analysis of the SPRINT AF registry assessed the prevalence of Canadian patients eligible for the reduced dose of apixaban or rivaroxaban (Gupta et al , ).…”

Section: Some Practical Considerationsmentioning

confidence: 99%

“…Emerging real‐world data suggest patients prescribed DOACs are not being dosed as defined in the clinical trials (Gupta et al , ; Weitz & Eikelboom, ) . An analysis of the SPRINT AF registry assessed the prevalence of Canadian patients eligible for the reduced dose of apixaban or rivaroxaban (Gupta et al , ). This analysis suggested that more patients are being prescribed a reduced dose of the factor Xa inhibitors than those who meet eligibility criteria (Gupta et al , ).…”

Section: Some Practical Considerationsmentioning

confidence: 99%

“…An analysis of the SPRINT AF registry assessed the prevalence of Canadian patients eligible for the reduced dose of apixaban or rivaroxaban (Gupta et al , ). This analysis suggested that more patients are being prescribed a reduced dose of the factor Xa inhibitors than those who meet eligibility criteria (Gupta et al , ). Recently, a large US database study reported on outcomes relating to dosing of DOACs (Yao et al , ).…”

Section: Some Practical Considerationsmentioning

confidence: 99%

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The use of direct oral anticoagulants in chronic kidney disease

Parker

Thachil

2018

Br J Haematol

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Increasing use of direct oral anticoagulants (DOACs) has made management of non-valvular atrial fibrillation and venous thromboembolism easier in most patients. But the presence of co-existing renal impairment could render the use of DOACs problematic because all of these drugs have varying degrees of renal excretion. In this paper we address misconceptions about the safety and efficacy of DOACs in moderate-severe renal impairment by presenting a summary of the literature from phase III trials and real-world studies. It also addresses the important consideration of correct estimate of renal function for DOAC dosing. It is hoped that the review will serve as a valuable resource for clinicians involved in anticoagulation decision-making in patients with renal impairment to guide the choice of most suitable agent. Accurate dosing is of particular relevance as registry data suggests it is done inconsistently and may be resulting in avoidable thromboembolic and bleeding events.

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Laboratory Monitoring of Non–Vitamin K Antagonist Oral Anticoagulant Use in Patients With Atrial Fibrillation

et al. 2017

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Robust evidence from patients with atrial fibrillation randomized to NOACs or warfarin demonstrates that unmonitored NOAC therapy is at least as effective and safe as monitored warfarin, with lower rates of intracranial hemorrhage and reduced mortality. Further research is required to determine whether routine laboratory monitoring might provide a net benefit for patients. Until such data are available, clinicians should continue to prescribe NOACs in fixed doses without routine monitoring.

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Underuse of Full Dose Factor Xa Inhibition in Atrial Fibrillation: Insight From the Sprint-Af Registry

Cited by 5 publications

References 0 publications

Nonvitamin K antagonist oral anticoagulant use in patients with renal impairment

Nonvitamin K antagonist oral anticoagulant use in patients with renal impairment

The use of direct oral anticoagulants in chronic kidney disease

Laboratory Monitoring of Non–Vitamin K Antagonist Oral Anticoagulant Use in Patients With Atrial Fibrillation

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