scholarly journals Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation

Medicine ◽  
2021 ◽  
Vol 100 (23) ◽  
pp. e26272
Author(s):  
I-Chih Chen ◽  
Wei-Ting Chang ◽  
Po-Chao Hsu ◽  
Ya-Lan Yeh ◽  
Syuan Zheng ◽  
...  
2017 ◽  
Vol 52 (1) ◽  
pp. 54-59 ◽  
Author(s):  
Caitlin M. Gibson ◽  
Carmen B. Smith ◽  
Sondra Davis ◽  
Michael J. Scalese

Background: Apixaban is a direct oral anticoagulant (DOAC) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Other DOACs require renal dose adjustments based solely on creatinine clearance. Apixaban differs in that its dose adjustments are more complex, potentially leading to prescribing errors. Objective: To determine if adherence to Food and Drug Administration (FDA)-approved dosing for apixaban is maintained in hospitalized patients with NVAF. Methods: Patients ≥18 years old with NVAF who received apixaban during admission to 1 of 3 hospitals were evaluated. The primary outcome was to determine if providers order apixaban in accordance with FDA-approved dosages. Secondary outcomes included determining if pharmacist review increased the number of orders in accordance with FDA-approved dosing, which of the 3 criteria (age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL) were met in patients receiving off-label dosing, and the rationale for off-label prescribing. Results: A total of 556 patients met inclusion criteria. Apixaban was dosed according to FDA labeling by providers in 83.4% (n = 464) of orders. After pharmacist review, 87.0% (n = 484) of orders were at the approved dose, 12.2% (n = 68) were underdosed, and 0.7% (n = 4) were overdosed. Most patients who were underdosed met only 1 dose reduction criterion—most commonly age ≥80 years (56.0%). Reasons for off-label dosing included home dose continuation (39.0%), history of or perceived bleeding risk (30.5%), or unspecified/other (30.5%). Conclusions: The majority of apixaban orders for NVAF were based on FDA-approved dosages after provider entry and pharmacist review.


Author(s):  
Jennifer A. Rymer ◽  
Laura Webb ◽  
Debbe McCall ◽  
Mellanie T. Hills ◽  
Tracy Y. Wang

Background Direct oral anticoagulants (DOACs) are effective in reducing the stroke risk for patients with nonvalvular atrial fibrillation if prescribed at the labeled dose, yet underdosing is frequent. Little is known about clinician knowledge and patient or clinician preferences for DOAC dosing. Methods and Results From April 2019 to March 2020, 240 clinicians and 343 patients with atrial fibrillation completed an assessment of anticoagulation knowledge/preferences. Clinician knowledge of DOAC dosing was tested with 4 hypothetical patient scenarios. Patients and clinicians were asked to grade the importance of 25 factors in anticoagulation decision making. Among clinicians, the median age was 55 years, and 23% were primary care clinicians. In scenarios of a patient indicated for full‐dose DOAC, 41.2% of clinicians underdosed apixaban and 17.6% underdosed rivaroxaban. In scenarios of a patient indicated for reduced‐dose DOAC, 64.6% and 71.7% of clinicians chose to use reduced‐dose apixaban and rivaroxaban, respectively. Only 35.0% of clinicians correctly answered all 4 scenarios with the label‐indicated dose; this knowledge gap was similar between clinicians who did and did not underdose. Among patients with atrial fibrillation, the median age was 65 years, and 89% were currently anticoagulated. Patients and clinicians ranked stroke prevention and avoiding severe bleeding as very important to anticoagulation decision making. Patients were more likely than clinicians to rank the ability to reduce anticoagulation dose if needed as very important (70.5% versus 43.6%; P <0.001). Conclusions There are considerable knowledge gaps regarding DOAC dosing in clinicians treating patients with atrial fibrillation, as well as significant differences in treatment dosing preferences between clinicians and patients.


2019 ◽  
Vol 20 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Pierluigi Merella ◽  
Giovanni Lorenzoni ◽  
Nicola Marziliano ◽  
Paola Berne ◽  
Graziana Viola ◽  
...  

2019 ◽  
Vol 105 (6) ◽  
pp. 1439-1455 ◽  
Author(s):  
Patrick Blin ◽  
Caroline Dureau‐Pournin ◽  
Yves Cottin ◽  
Jacques Bénichou ◽  
Patrick Mismetti ◽  
...  

2021 ◽  
Vol 10 (17) ◽  
pp. 3918
Author(s):  
Sola Han ◽  
Young-Hoon Kim ◽  
Myung-Yong Lee ◽  
Oh Young Bang ◽  
Sung-Won Jang ◽  
...  

Reduced-dose nonvitamin K antagonist oral anticoagulants (NOACs) are commonly prescribed to Asian patients with nonvalvular atrial fibrillation (NVAF). We aimed to compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) between patients treated with reduced-dose NOACs and those treated with warfarin, using the claims database in Korea. Patients with NVAF newly initiated on oral anticoagulants (OACs; apixaban, dabigatran, rivaroxaban, and warfarin) between 1 July 2015 and 30 November 2016 were included. Among all patients with NVAF treated with OACs, 5249, 6033, 7602, and 8648 patients were treated with reduced-dose apixaban, dabigatran, rivaroxaban, and warfarin, respectively. Patients treated with reduced-dose NOACs were older and had higher CHA2DS2-VASc and HAS-BLED scores than those treated with warfarin. Compared to warfarin, all reduced-dose NOACs showed significantly lower risk of S/SE (hazard ratios (95% confidence interval), 0.63 (0.52–0.75) for apixaban; 0.51 (0.42–0.61) for dabigatran; and 0.67 (0.57–0.79) for rivaroxaban) and MB (0.54 (0.45–0.65) for apixaban; 0.58 (0.49–0.69) for dabigatran; 0.73 (0.63–0.85) for rivaroxaban). In the real-world practice among Asians with NVAF, all reduced-dose NOACs were associated with a significantly lower risk of S/SE and MB compared to those of warfarin.


1997 ◽  
Vol 77 (05) ◽  
pp. 0845-0848 ◽  
Author(s):  
B G Koefoed ◽  
C Feddersen ◽  
A L Gulløv ◽  
P Petersen

SummaryThe efficacy of conventional dose adjusted oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation is well- documented but not considered ideal as primary antithrombotic treatment in elderly patients. The antithrombotic effect of fixed minidose warfarin 1.25 mg/day alone or in combination with aspirin 300 mg/day, of conventional dose adjusted warfarin (INR 2.0-3.0), and of aspirin 300 mg/day have been investigated in outpatients with chronic nonvalvular atrial fibrillation in the second Copenhagen Atrial Fibrillation, Aspirin and Anticoagulant Therapy Study (AFASAK 2). In order to investigate the effect on the coagulation system of the treatments, the International Normalized Ratio of the prothrombin time (INR) and prothrombin fragment 1 + 2 (F1 +2) were monitored at baseline and after three months of treatment in 100 patients consecutively included in the trial. At baseline no differences in INR and F1+2 between the four treatment groups were present. After three months of therapy the level of INR increased significantly from baseline in patients receiving warfarin in any dose and the level of F1+2 decreased significantly by combined minidose warfarin-aspirin and by dose adjusted warfarin. When comparing the changes over time in FI +2 (three-month value minus baseline value) during therapy with fixed minidose warfarin, combined minidose warfarin-aspirin and aspirin alone no significant difference between the groups was found. In conclusion, INR was changed by all three warfarin regimens but only dose adjusted warfarin (INR 2.0-3.0) had a marked effect on F1+2.


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