scholarly journals Evaluation of Apixaban for the Treatment of Nonvalvular Atrial Fibrillation With Regard to Dosing and Safety in a Community Hospital

2017 ◽  
Vol 33 (4) ◽  
pp. 140-145 ◽  
Author(s):  
Katie B. Tellor ◽  
Michelle Wang ◽  
Melissa S. Green ◽  
Anastasia L. Armbruster
Keyword(s):  
Atrial Fibrillation ◽  
Community Hospital ◽  
Factor Xa ◽  
Retrospective Chart Review ◽  
Prescribing Patterns ◽  
Minor Bleeding ◽  
Nonvalvular Atrial Fibrillation ◽  
Hospital Design ◽  
Patient Demographics ◽  
Dosing Regimens

Background: Apixaban, a direct factor Xa inhibitor, is approved by the US Food and Drug Administration (FDA) for prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. Apixaban’s compelling safety and efficacy data, combined with minimal laboratory monitoring, make it an attractive anticoagulant. Objectives: To characterize and evaluate the dosing and safety of apixaban for the treatment of nonvalvular atrial fibrillation at a community hospital. Design/Patients: A retrospective chart review evaluated patients ≥18 years of age who received at least 2 consecutive doses of apixaban from January 1, 2013 to June 30, 2016. Patients with multiple admissions were evaluated for each hospitalization. Patients were excluded if height, weight, or serum creatinine was not documented during hospital admission. Patients who received apixaban for the treatment or prophylaxis of venous thromboembolism were excluded. Prescribing patterns were characterized based on FDA-approved dosing regimens and patient demographics. Safety outcomes included incidences of major, clinically relevant nonmajor, and minor bleeding. Results: Of the 707 patients evaluated, 82% received an FDA-approved apixaban regimen. Of the 127 patients (18%) who received an unapproved regimen, 5.5% (7 patients) received an unapproved frequency and 94.5% (120 patients) received an unapproved dose. The majority (98 patients, 81.7%) were underdosed. Composite bleeding rates were 2.7%, with 1.8% major bleeds, 0.7% clinically relevant nonmajor bleeds, and 0.1% minor bleeds. Conclusions: The use of apixaban must be monitored in order to ensure FDA-approved dosing regimens are being prescribed and patients are not being underdosed.

scholarly journals Apixaban-Calibrated Anti-FXa Activity in Relation to Outcome Events and Clinical Characteristics in Patients with Atrial Fibrillation: Results from the AVERROES Trial

TH Open ◽  
2017 ◽  
Vol 01 (02) ◽  
pp. e139-e145 ◽  
Author(s):  
Vinai Bhagirath ◽  
John Eikelboom ◽  
Jack Hirsh ◽  
Michiel Coppens ◽  
Jeffrey Ginsberg ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Clinical Characteristics ◽  
Factor Xa ◽  
Entire Group ◽  
Minor Bleeding ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Clinical Trial Registration

Background In patients with nonvalvular atrial fibrillation (AF), apixaban is given in doses of 5 or 2.5 mg twice daily, according to clinical characteristics. The usual on-treatment range of apixaban drug levels, as determined by apixaban-calibrated anti-factor Xa (anti-Xa) activity, has previously been measured in small cohorts; however, the association between anti-Xa activity and clinical outcomes and the predictors of variability in anti-Xa activity have not been well studied in the AF population. Methods and Results Anti-Xa activity was measured before taking the morning dose, 3 months after enrollment in the AVERROES study using a calibrated anti-Xa assay (Rotachrom). Patients with two of the following criteria—age >80; weight <60 kg; or creatinine >133 μg/L—received 2.5 mg twice daily (n = 145), while all others received 5 mg twice daily (n = 2,247). A total of 2,392 patients were included, with median follow-up of 1.1 years. Median apixaban anti-Xa activity was 122 ng/mL (interquartile range [IQR]: 63–198 ng/mL) for the entire group; 99 ng/mL (IQR: 60–146 ng/mL) for the 2.5-mg group; and 125 ng/mL (IQR: 64–202 ng/mL) for the 5-mg group (p = 0.003). A relationship was evident between bleeding and anti-Xa activity (p = 0.01), which was driven by minor bleeding. No relationship was evident between major bleeding or stroke/systemic embolism and anti-Xa activity. In those receiving the 5-mg dose, estimated glomerular filtration rate, sex, and age had the strongest association with anti-Xa activity. Conclusion There is considerable variability in anti-Xa activity among AF patients receiving apixaban. Rates of major bleeding and stroke/systemic embolism were low irrespective of anti-Xa activity. Clinical Trial Registration ClinicalTrials.gov NCT00496769; https://clinicaltrials.gov/ct2/show/NCT00496769.

scholarly journals Rivaroxaban versus Warfarin for Prevention of Thromboembolism in Bangladeshi Patients with Non-Valvular Atrial Fibrillation

2020 ◽  
Vol 16 (2) ◽  
pp. 99-105
Author(s):  
Golam Sodruddin ◽  
Md Mukhlesur Rahman ◽  
SM Ahsan Habib ◽  
MSI Tipu Chowdhury ◽  
Adnan Bashar ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Factor Xa ◽  
Haemorrhagic Stroke ◽  
Similar Efficacy ◽  
Minor Bleeding ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Safety Outcome ◽  
Warfarin Group ◽  
Bangladeshi Population

Background: The use of Warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulant effects than Warfarin. Methods: In this Open comparison trial, the researchers compared Rivaroxaban (at a daily dose of 20 mg or 15 mg daily in patient with a creatinine clearance of 30-49 ml/min ) with dose adjusted Warfarin (target INR 2.0 to3.0) in 2,846 patients with nonvalvular atrial fibrillation and CHA2DS2-VASc Score 2 or more. The primary efficacy outcome was stroke or systemic embolism and primary safety outcome was major or minor bleeding. This research was designed to determine whether Rivaroxaban have more efficacy and safety than Warfarin for the primary outcomes. Results: Total follow-up period was 6 months. Risk factors and co-morbidities were similar in both groups. Baseline investigations were also similar. Age and sex of both groups were matched. The rate of ischaemic stroke was 1.8% in Rivaroxaban group, as compared with 2.18% in the Warfarin group (p 0.479, nonsignificant). The rate of haemorrhagic stroke was 0.53% in Rivaroxaban group, as compared with 1.36 % in the Warfarin group (p 0.026, significant). Systemic embolism was 0.08% in Rivaroxaban group, as compared with 0.15 % in the Warfarin group (p 0.561, non-significant). The rate of major bleeding was 0.4% in Rivaroxaban group and 0.53 % in the Warfarin group (p 0.361, non-significant). The rate of minor bleeding was 2.10% in Rivaroxaban group, as compared with 2.33% in the Warfarin group (p 0.681, non-significant). Conclusions: Rivaroxaban have similar efficacy and better safety profile than Warfarin in patients with nonvalvular atrial fibrillation in Bangladeshi population. University Heart Journal Vol. 16, No. 2, Jul 2020; 99-105

Probable Rivaroxaban-Induced Full Body Rash: A Case Report

2017 ◽  
Vol 31 (5) ◽  
pp. 503-506 ◽  
Author(s):  
Evan Sasson ◽  
Marian James ◽  
Mark Russell ◽  
Darko Todorov ◽  
Henry Cohen
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Drug Events ◽  
Factor Xa ◽  
Similar Reaction ◽  
Medication Regimen ◽  
Nonvalvular Atrial Fibrillation ◽  
Novel Oral Anticoagulant ◽  
History Of ◽  
Potential Issue ◽  
Full Body

Introduction: Rivaroxaban is a novel oral anticoagulant with several indications, one of which is for stroke prevention in nonvalvular atrial fibrillation. We present a case of probable rivaroxaban-induced rash. Case Summary: A 79-year-old female with a medical history of atrial fibrillation experienced a stroke, after which she was prescribed rivaroxaban 20 mg. After several days, she developed a rash requiring admission to the emergency department and several days of treatment. The rash resolved and she was switched from rivaroxaban to apixaban and did not experience any adverse drug events. Discussion: Onset of symptoms occurred within days of rivaroxaban initiation. The patient had no allergy history and never reported a similar reaction while on concurrent home medication regimen. The resolution of rash and toleration of apixaban suggest a rivaroxaban-specific reaction. The mechanism of this rash is currently unclear. Conclusion: We report one of the first cases of probable rivaroxaban-induced rash, whereas the patient tolerated apixaban. Further investigation is warranted, but prescribers should be cognizant of this potential issue when choosing a factor Xa inhibitor for anticoagulation.

scholarly journals Anticoagulant Utilization and Direct Oral Anticoagulant Prescribing in Patients with Nonvalvular Atrial Fibrillation

2019 ◽  
Vol 72 (6) ◽  
Author(s):  
Priscilla Shum ◽  
Gordon Klammer ◽  
Dale Toews ◽  
Arden Barry
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulant ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Renal Dialysis ◽  
Retrospective Chart Review ◽  
Patient Characteristics ◽  
Nonvalvular Atrial Fibrillation ◽  
Patients Âgés ◽  
Fibrillation Auriculaire

ABSTRACTBackground: Direct oral anticoagulants (DOACs) are indicated for prevention of stroke and embolism in patients with nonvalvular atrial fibrillation (NVAF). These agents have been shown to be non-inferior to warfarin in terms of efficacy and safety. However, their uptake in practice has been variable, and prescribed dosages may be inconsistent with manufacturer recommendations.Objectives: To evaluate patterns of oral anticoagulant use in patients with NVAF, including determination of patient characteristics associated with the prescribing of warfarin or DOACs and whether prescribed dosages of DOACs were concordant with manufacturer recommendations.Methods: This retrospective chart review was conducted from April to September 2017 at Abbotsford Regional Hospital, Abbotsford, British Columbia. Patients at least 18 years of age with NVAF and CHADS-65 score of 1 or higher were included. Patients with contraindications to oral anticoagulants, those with reversible atrial fibrillation, and those undergoing renal dialysis were excluded. The dosage of DOACs was categorized as too low, too high, or correct in relation to manufacturer recommendations for the Canadian product. Results: A total of 120 patients were included. At discharge, 83 (69%) of the patients had a prescription for DOAC, 25 (21%) had a prescription for warfarin, and 12 (10%) had no prescription for an oral anticoagulant. There were no statistically significant differences between the warfarin and DOAC groups with respect to patient characteristics. Among the 56 patients for whom a full DOAC dose was indicated, 7 (13%) received a dose that was too low. Among the 23 patients for whom a full DOAC dose was not indicated, 4 (17%) received a dose that was too high. Conclusions: At the study hospital, most patients with NVAF and CHADS-65 score of at least 1 had a discharge prescription for DOAC. Patient characteristics appeared to be similar between the warfarin and DOAC groups. For a notable proportion of patients who received a DOAC, the dosage was incorrect. Appropriate prescribing of oral anticoagulants could be further improved by education for prescribers and involvement of hospital pharmacists.RÉSUMÉContexte : Les anticoagulants oraux directs (AOD) sont indiqués pour prévenir les AVC et les embolies parmi les patients atteints de fibrillation auriculaire non valvulaire (FANV). Il a été démontré que l’efficacité et l’innocuité de ces agents n’étaient pas inférieures à la warfarine. Cependant, leur adoption dans la pratique est inégale, et les doses prescrites peuvent être contraires aux recommandations des fabricants.Objectifs : Évaluation des habitudes d’utilisation des anticoagulants oraux pour les patients atteints de FANV, y compris la définition des caractéristiques des patients associées à la prescription de la warfarine ou des AOD, ainsi que de la conformité des doses prescrites de ces derniers aux recommandations des fabricants.Méthodes : Cet examen rétrospectif des dossiers a été mené d’avril à septembre 2017 à l’Hôpital régional d’Abbotsford à Abbotsford, en Colombie-Britannique. Des patients âgés d’au moins 18 ans, atteints de FANV et ayant un score CHADS-65 d’au moins 1, ont été inclus dans l’étude. Les patients présentant une contre-indication aux anticoagulants oraux, ceux atteints de fibrillation auriculaire réversible et ceux soumis à une dialyse rénale en ont été exclus. La dose d’AOD destinés au marché canadien a été catégorisée comme trop faible, trop élevée ou correcte par rapport aux recommandations du fabricant.Résultats : Cent-vingt patients au total ont participé à l’étude. Au moment du congé, 83 (69 %) d’entre eux avaient une prescription d’AOD, 25 (21 %) avaient une prescription de warfarine et 12 (10 %) n’avaient pas de prescription d’anticoagulant oral. En ce qui concerne les caractéristiques des patients, il n’y avait aucune différence statistique notable entre les groupes ayant reçu une prescription de warfarine et ceux ayant reçu une prescription d’AOD. Des 56 patients qui avaient reçu une indication de dose complète d’AOD, sept (13 %) ont reçu une dose trop faible. Des 23 patients qui n’avaient pas reçu d’indication de dose complète d’AOD, quatre (17 %) ont reçu une dose trop élevée.Conclusions : À l’hôpital où s’est déroulée l’étude, la plupart des patients atteints de FANV et ceux ayant un score CHADS-65 d’au moins 1 recevaient une prescription d’AOD au moment du congé. Les caractéris-tiques des patients semblaient similaires entre les groupes ayant reçu une prescription de warfarine et ceux ayant reçu une prescription d’AOD. La dose d’AOD reçue par une proportion notable de patients était incorrecte. La prescription appropriée d’anticoagulants oraux pourrait encore être améliorée si on sensibilisait les prescripteurs avec la collaboration des pharmaciens d’hôpitaux.   

scholarly journals The role of edoxaban in preventing thromboembolic complications in patients with atrial fibrillation

2020 ◽  
pp. 28-43
Author(s):  
O. O. Shakhmatova
Keyword(s):  
Atrial Fibrillation ◽  
Drug Interactions ◽  
Dose Reduction ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Extensive Study ◽  
Thromboembolic Complications ◽  
Nonvalvular Atrial Fibrillation ◽  
Life Threatening

Edoxaban is a selective direct factor Xa inhibitor. Edoxaban in a dose of 60 mg per day is an effective and safe option in the prevention of thromboembolic complications in patients with nonvalvular atrial fibrillation, including in combination therapy in patients after percutaneous coronary interventions. ENGAGE AF-TIMI 48 is currently the most extensive study comparing direct oral anticoagulants and warfarin in patients with atrial fibrillation, both in terms of number of participants and duration of observation. For edoxaban, an adequate approach to dose reduction has been developed in patients with alikely increase in plasma concentration due to renal impairment, low body weight or inter-drug interactions. Such dose reduction does notlead to an increase in the frequency of ischemic complications.Edoxaban is characterized by an optimal safety profile in patients with chronic moderate kidney disease, a small number of drug interactions and a convenient mode of administration. In patients with atrial fibrillation and concomitant ischemic heart disease, the use of Edoxaban is associated with a decrease in the frequency of myocardial infarctions, as well as strokes and episodes of systemic thromboembolism in comparison with warfarin. The drug can be successfully used as anticoagulant support for cardioversion and catheter ablation for atrial fibrillation.Edoxaban intake does not require routinelaboratory control. In case of unexpected situations (life-threatening bleeding, urgent surgical intervention) in patients receiving edoxaban, to assess the degree of anticoagulation should use the determination of anti-Xa activity. Clinical studies of a specific antidote of edoxaban - andexanet alfa are ongoing. Before approval of the specific antidote in severe andlife-threatening bleedings against the background of edoxaban administration, the use of prothrombin complex concentrate should be considered. Data on the effective and safe use of edoxaban in routine clinical practice have been accumulated.

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