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

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.

Approved Uses of Dabigatran Etexilate as an Anticoagulant

2011 ◽  
Vol 27 (6) ◽  
pp. 258-265
Author(s):  
Joshua B Darnell ◽  
Erika L Kleppinger
Keyword(s):  
Atrial Fibrillation ◽  
Data Extraction ◽  
Dabigatran Etexilate ◽  
Anticoagulation Therapy ◽  
Minor Bleeding ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Phase 3 ◽  
Study Selection ◽  
Life Threatening

Objective: To review, analyze, and critique dabigatran etexilate's approved uses as an anticoagulant. Data Sources: Literature searches were performed via MEDLINE, International Pharmaceutical Abstracts, and Google Scholar through February 2011, using the term dabigatran. Additional data were obtained from tertiary sources and prescribing information. Study Selection and Data Extraction: All published Phase 3 anticoagulation trials investigating dabigatran for currently approved indications were selected. Information from other anticoagulation trials investigating dabigatran was used for critiquing Phase 3 studies. Data Synthesis: Dabigatran etexilate has been evaluated in multiple clinical trials as an alternative to enoxaparin for prevention of venous thromboembolism in total hip and knee replacement surgeries. It has also been evaluated as an alternative to warfarin in stroke and systemic embolism prevention in patients with atrial fibrillation. Results have generally been positive, with few exceptions. The standard adult dose of dabigatran 150 mg twice daily, approved for use in the US for stroke prevention in nonvalvular atrial fibrillation, was found to be superior to warfarin in regard to occurrence rates of stroke or systemic embolism and hemorrhagic stroke. The occurrence rates of intracranial bleeding, life-threatening bleeding, and major or minor bleeding were lower with dabigatran 150 mg twice daily than with warfarin; however, the occurrence of gastrointestinal bleeding was significantly higher. Conclusions: With its numerous benefits, and despite its drawbacks, dabigatran remains a promising option for oral anticoagulation therapy.

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 A single institution’s experience with using dabigatran, rivaroxaban and warfarin for prevention of thromboembolism in atrial fibrillation

2017 ◽  
Vol 27 (1) ◽  
pp. 20-25 ◽  
Author(s):  
Li Xin Chan ◽  
Yee May Wong ◽  
Pow-Li Chia ◽  
Zhen Liang Kek
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Oral Anticoagulants ◽  
Tertiary Hospital ◽  
Minor Bleeding ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Warfarin Group ◽  
One Year

Background: Although non-vitamin K antagonist oral anticoagulants (NOACs) are approved for stroke prevention in atrial fibrillation (AF) patients, their use in the local clinical setting has not been well studied. This study aims to evaluate the clinical outcomes of dabigatran, rivaroxaban and warfarin in a tertiary hospital in Singapore. Methods: This is a retrospective cohort study with one-year follow-up. A total of 383 patients recruited between June 2011 and December 2014 were studied. Incidents of stroke, systemic embolism and clinically relevant bleeding events were compared between dabigatran, rivaroxaban and warfarin. Results: Stroke rates were 5.47% per year with warfarin, 7.27% per year with dabigatran (HR=1.32; 95% CI 0.48−3.64; p=0.591) and 2.76% per year with rivaroxaban (HR=0.49; 95% CI 0.14−1.69; p=0.261). The warfarin group had significantly higher incidence of minor bleeding (62.4% vs 3.64% for dabigatran vs 13.79% for rivaroxaban; p<0.001), major bleeding (3.91% for warfarin, 0.91% for dabigatran, 0% for rivaroxaban; p=0.028) and other adverse events (51.18% for warfarin, 3.64% for dabigatran, 8.28% for rivaroxaban; p<0.001). Incidence of dyspepsia was higher in both NOAC groups compared to warfarin (0% for warfarin, 7.27% for dabigatran, 5.52% for rivaroxaban; p=0.003). Conclusion: Stroke and venous thromboembolism rates after one year were comparable among dabigatran, rivaroxaban and warfarin. Warfarin was associated with more bleeding and adverse events while both NOACs were associated with higher rates of dyspepsia. Further study is needed to assess the clinical benefit of NOACs in the Singaporean population.

scholarly journals Apixaban in Comparison to Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-Analysis of Observational Studies

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Muhammad U. Siddiqui ◽  
David Scalzitti ◽  
Zunaira Naeem
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Safety Outcome ◽  
Increased Risk

Introduction. Atrial fibrillation leads to increased risk of systemic embolism and stroke. To decrease these adverse events, anticoagulation is routinely prescribed. Nonvitamin K anticoagulants like apixaban and rivaroxaban are becoming popular and being used more frequently nowadays. We here compare the efficacy and safety of apixaban with those of warfarin. Methods and Analysis. This systematic review aims to assess the efficacy and safety of apixaban compared to those of warfarin. Eligible participants were adults diagnosed with nonvalvular atrial fibrillation. The intervention was apixaban, and the comparator was warfarin. The primary efficacy endpoint is the first admission with systemic embolism or stroke, and the primary safety outcome is the occurrence of major bleeding. Relevant studies were searched in the Cochrane Central Register of Controlled Trials, MEDLINE, PubMed, and clinicaltrials.gov. After being independently reviewed by two authors, five articles were included in the systematic review. The risk of bias of included studies was assessed using the Cochrane risk of bias tool and SIGN methodology. The RevMan software was used to assess the effect size and perform meta-analysis. Results. Apixaban was found to be superior to warfarin in terms of safety (RR 0.58; CI 0.52–0.66) but not superior to warfarin in terms of efficacy (RR 0.93; CI 0.70–1.24). Conclusion. Apixaban is superior to warfarin in terms of safety, but no difference in efficacy is noted. The choice of anticoagulation should be individualized based on the risk factor profile of the patient.

scholarly journals Dabigatran and warfarin in nonvalvular atrial fibrillation or atrial flutter in outpatient clinic practice in Brazil

2019 ◽  
Vol 77 (2) ◽  
pp. 80-83 ◽  
Author(s):  
Jean Michell Correia Monteiro ◽  
Daniel Lordelo San-Martin ◽  
Beatriz Carneiro Gondim Silva ◽  
Ian Felipe Barbosa Souza ◽  
Jamary Oliveira Filho ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Flutter ◽  
Major Bleeding ◽  
Thromboembolic Event ◽  
Minor Bleeding ◽  
Nonvalvular Atrial Fibrillation ◽  
Warfarin Group ◽  
Clinic Practice ◽  
Prior Stroke

ABSTRACT Objectives: To compare warfarin and dabigatran for thromboembolic event prevention in patients with nonvalvular atrial fibrillation or atrial flutter. Methods: This was a retrospective cohort of participants with nonvalvular atrial fibrillation or atrial flutter using either warfarin or dabigatran in a reference center in Brazil. Results: There were 112 patients (mean age 65.5 years), with 55.3% using warfarin. The median duration of follow-up was 1.9 years for warfarin and 1.6 years for dabigatran (p = 0.167). Warfarin patients had a higher median of medical appointments per year (8.3 [6.8-10.4] vs 3.1 [2.3-4.2], p < 0.001) and the frequency of minor bleeding was more than four times higher (17.7% vs 4.0%, p = 0.035). Among patients with prior stroke, those using warfarin had 2.6 times more medical appointments for person-years of follow-up (8.5 vs 3.3). There was no major bleeding or embolic event during follow-up period. Conclusion: The dabigatran group had a lower frequency of minor bleeding and number of medical appointments than the warfarin group, without more embolic events or major bleeding.

scholarly journals Patient characteristics and stroke and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban and vitamin K antagonists: a Spanish real-world study

2019 ◽  
Vol 8 (14) ◽  
pp. 1201-1212 ◽  
Author(s):  
Sreeram V Ramagopalan ◽  
Antoni Sicras-Mainar ◽  
Carlos Polanco-Sanchez ◽  
Robert Carroll ◽  
Jaime F de Bobadilla
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Medical Records ◽  
Vitamin K Antagonists ◽  
Patient Characteristics ◽  
Minor Bleeding ◽  
Thromboembolic Events ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation

Aim: To compare the risk of stroke, systemic thromboembolism and bleeding, in patients initiating apixaban or acenocoumarol for the treatment of nonvalvular atrial fibrillation. Methods: An observational, retrospective study was performed using medical records of patients who initiated apixaban or acenocoumarol between 2015 and 2017. Propensity score matching was used to match patients; stroke, systemic thromboembolism, major and minor bleeding events were compared between the matched patients. Results: Patients who were prescribed apixaban had a lower rate of systemic embolism/stroke (hazard ratio [HR] = 0.54; 95% CI: 0.38–0.78; p = 0.001), minor bleeding (HR = 0.64; 95% CI: 0.52–0.79; p < 0.001) and major bleeding (HR = 0.51; 95% CI: 0.37–0.72; p < 0.001). Conclusion: Patients prescribed apixaban for the treatment of nonvalvular atrial fibrillation had lower rates of thromboembolic events and minor/major bleeding than patients on acenocoumarol.

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