Dataset Information

Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data.

ABSTRACT: BACKGROUND:No studies have directly compared the effectiveness and safety of dabigatran and rivaroxaban using US Medicare data. OBJECTIVE:Our objective was to compare effectiveness and safety between rivaroxaban 20 mg/dabigatran 150 mg and rivaroxaban 15 mg/dabigatran 75 mg among patients with atrial fibrillation (AF). METHODS:Using 2010-2013 US Medicare Part D data, we selected patients with AF initiating dabigatran 150/75 mg or rivaroxaban 20/15 mg between 4 November 2011 (when rivaroxaban was approved) and 31 December 2013. Our sample included 7322 patients receiving dabigatran 150 mg, 5799 patients receiving rivaroxaban 20 mg, 1818 receiving dabigatran 75 mg, and 2568 receiving rivaroxaban 15 mg. We followed them until stroke, other thromboembolic events, bleeding, discontinuation or switch of an anticoagulant, death, or 31 December 2013. We constructed Cox proportional hazard models with propensity score weighting to compare clinical outcomes between groups. RESULTS:There was no difference in the risk of stroke between dabigatran 150 mg and rivaroxaban 20 mg (hazard ratio [HR] 1.05; 95 % confidence interval [CI] 0.97-1.13) or between dabigatran 75 mg and rivaroxaban 15 mg (HR 1.05; 95 % CI 0.94-1.18). Compared with dabigatran 150 mg, rivaroxaban 20 mg was associated with a higher risk of other thromboembolic events (HR 1.28; 95 % CI 1.14-1.44), major bleeding (HR 1.32; 95 % CI 1.17-1.50), and death (HR 1.36; 95 % CI 1.19-1.56). The risk of thromboembolic events other than stroke (HR 1.37; 95 % CI 1.15-1.62), major bleeding (HR 1.51; 95 % CI 1.25-1.82), and death (HR 1.21; 95 % CI 1.04-1.41) was also higher for rivaroxaban 15 mg than for dabigatran 75 mg. CONCLUSIONS:There was no difference in stroke prevention between rivaroxaban and dabigatran; however, rivaroxaban was associated with a higher risk of thromboembolic events other than stroke, death, and bleeding.

SUBMITTER: Hernandez I

PROVIDER: S-EPMC6572759 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data.

Hernandez Inmaculada I Zhang Yuting Y

American journal of cardiovascular drugs : drugs, devices, and other interventions 20170201 1

<h4>Background</h4>No studies have directly compared the effectiveness and safety of dabigatran and rivaroxaban using US Medicare data.<h4>Objective</h4>Our objective was to compare effectiveness and safety between rivaroxaban 20 mg/dabigatran 150 mg and rivaroxaban 15 mg/dabigatran 75 mg among patients with atrial fibrillation (AF).<h4>Methods</h4>Using 2010-2013 US Medicare Part D data, we selected patients with AF initiating dabigatran 150/75 mg or rivaroxaban 20/15 mg between 4 November 2011 ...[more]

PMID: 27637493

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Project description:IMPORTANCE:It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice. OBJECTIVE:To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data. DESIGN, SETTING, AND PARTICIPANTS:In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011. EXPOSURES:Dabigatran users (n = 1302) and warfarin users (n = 8102). MAIN OUTCOMES AND MEASURES:We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities. RESULTS:Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease. CONCLUSIONS AND RELEVANCE:Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.

Project description:Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used for prevention of stroke secondary to nonvalvular atrial fibrillation (NVAF). Increased use of NOACs is partially a result of simplified regimens compared with warfarin, which has been associated with poor adherence and persistence to therapy. Few studies have assessed adherence to NOACs, especially using contemporary data now that multiple NOACs are available.To evaluate adherence to NOACs in a cohort of newly diagnosed NVAF patients who are commercially insured.Incident, treatment-naïve NVAF patients were identified in 2013 from a large claims database. Patients were included who initiated rivaroxaban, dabigatran, or apixaban within 30 days after diagnosis. Subjects were required to have 12 months of pre-index information to assess demographic and clinical characteristics (comorbidities, CHA2 DS2-VASc, and HAS-BLED scores). Adherence to the index medication and adherence to any oral anticoagulant was assessed using proportion of days covered (PDC) at 3, 6, and 9 months. The number of switches and gaps in therapy were also evaluated. Analyses were stratified by stroke risk scores, and a logistic regression model was used to control for factors that may predict high adherence (PDC ? 0.80).A total of 3,455 rivaroxaban, 1,264 dabigatran, and 504 apixaban users were included with no major clinical or demographic differences between groups. At 3, 6, and 9 months of follow-up, dabigatran had lower adherence (PDC = 0.77, 0.67, and 0.62) compared with rivaroxaban (PDC = 0.84, 0.75, and 0.70; P < 0.001) and apixaban (PDC = 0.82, 0.75, and 0.71; P < 0.001), as well as nearly twice the number of switches to either other anticoagulants or antiplatelet therapy. At 9 months, 55.0% of rivaroxaban initiators had PDC ? 0.80, which was comparable with 56.8% for apixaban and significantly greater than 46.7% for dabigatran (P < 0.001). Adherence was higher overall as stroke risk increased and showed dabigatran had consistently lower adherence compared with the other NOACs. Overall adherence to any oral anticoagulants, allowing for switches to another NOAC or warfarin, was not dependent on the index medication (9-month PDC = 0.74, 0.71, and 0.74 for rivaroxaban, dabigatran, and apixaban initiators). Adjusted analyses showed that increasing age and comorbid hypertension and diabetes were associated with higher adherence. Compared with rivaroxaban, dabigatran initiators had nearly 30% lower odds of being adherent to their index medication, and no differences were observed between apixaban and rivaroxaban. At 9 months, there were no differences between NOACs for overall adherence to oral anticoagulants.In this real-world analysis of adherence to NOACs, rivaroxaban and apixaban had favorable profiles compared with dabigatran, and rivaroxaban appeared to have higher overall adherence among the NOACs. Clinicians and managed care organizations should consider the implications of lower adherence on clinical outcomes as well as quality assessment.The project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through grant number UL1TR000117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. Brown reports receiving a training fellowship from Human and Pfizer. Study concept and design were contributed by Brown and Shewale. Talbert took the lead in data collection, along with Brown, and data interpretation was primarily performed by Brown, along with Shewale. The manuscript was written primarily by Brown, along with Shewale, and revised by all the authors.

Project description:Few studies have assessed adherence to non-vitamin K antagonist oral anticoagulants (NOACs), especially using contemporary data now that multiple NOACs are available.To compare adherence and treatment patterns among NOACs for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).Incident and treatment-naive NVAF patients were identified during 2013-2014 from a large claims database in this retrospective cohort study. Patients were included who initiated rivaroxaban, dabigatran, or apixaban within 30 days after diagnosis. Adherence to the index medication and adherence to any oral anticoagulant was assessed using the proportion of days covered (PDC) at 3, 6, and 9 months. The number of switches and gaps in therapy were also evaluated. Analyses were stratified by stroke risk scores, and a logistic regression model was used to control for factors that may predict high adherence.Dabigatran had lower adherence (PDC = 0.76, 0.64, 0.57) compared with rivaroxaban (PDC = 0.83, 0.73, 0.66; P < 0.001) and apixaban (PDC = 0.82, 0.72, 0.66; P < 0.001) at 3, 6, and 9 months of follow-up and twice the number of switches to either other anticoagulants or antiplatelet therapy. Adherence was higher overall as stroke risk increased, and dabigatran had consistently lower adherence compared with the other NOACs. Multivariable logistic regression predicting PDC ? 0.80 showed rivaroxaban users with higher odds of high adherence compared with dabigatran or rivaroxaban across all time periods. Adjusted analyses showed that increasing age and comorbid hypertension and diabetes were associated with higher adherence.In this real-world analysis of adherence to NOACs, rivaroxaban and apixaban had favorable unadjusted adherence profiles compared with dabigatran, while rivaroxaban users had higher odds of high adherence (PDC ? 0.80) among the NOACs in adjusted analyses. Clinicians and managed care organizations should consider the implications of lower adherence on clinical outcomes and quality assessment.This project was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through grant number UL1TR000117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The authors have nothing to disclose. Study concept and design were contributed by Brown and Shewale. Brown and Talbert collected the data, and data analysis was performed primarily by Brown, along with Shewale and Talbert. The manuscript was written primarily by Brown, along with Shewale, and revised by all the authors.

Dataset Information

Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data.

Publications

Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data.

Similar Datasets

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