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Clinical utility of rivaroxaban in stroke prevention associated with nonvalvular atrial fibrillation - patient considerations.

ABSTRACT: The direct factor Xa inhibitor rivaroxaban was the first within the group of orally available direct factor Xa inhibitors to gain clinical approval for oral anticoagulation in patients with nonvalvular atrial fibrillation in 2011. The -xabans, as drugs from the group of oral direct factor Xa inhibitors are often referred to, comprise currently three drugs (apixaban, edoxaban, and rivaroxaban) with clinical approval for a variety of clinical indications that require oral anticoagulation therapy. The number of patients with nonvalvular atrial fibrillation requiring long-term oral anticoagulation therapy for the prevention of stroke and systemic embolism is predicted to increase up to five times by 2050. Many of these patients will be within the elderly and aging population that is at a higher risk of stroke and also at a higher risk for bleeding events. This requires novel options for efficient and safe oral anticoagulation, and rivaroxaban is one of the novel oral anticoagulants that have been shown to be at least as effective as vitamin K antagonists in patients with nonvalvular atrial fibrillation. Furthermore, like all of the novel oral anticoagulants, rivaroxaban provides a significant reduction in intracerebral hemorrhage compared with vitamin K antagonists such as warfarin. The clinical utility of oral anticoagulation with rivaroxaban in patients with nonvalvular atrial fibrillation is discussed here, along with special patient considerations, including impaired renal function, switching from a vitamin K antagonist, and patients with concomitant acute coronary syndrome.

SUBMITTER: Ahrens I

PROVIDER: S-EPMC3938442 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Clinical utility of rivaroxaban in stroke prevention associated with nonvalvular atrial fibrillation - patient considerations.

Ahrens Ingo I Bode Christoph C

Journal of blood medicine 20140224

The direct factor Xa inhibitor rivaroxaban was the first within the group of orally available direct factor Xa inhibitors to gain clinical approval for oral anticoagulation in patients with nonvalvular atrial fibrillation in 2011. The -xabans, as drugs from the group of oral direct factor Xa inhibitors are often referred to, comprise currently three drugs (apixaban, edoxaban, and rivaroxaban) with clinical approval for a variety of clinical indications that require oral anticoagulation therapy. ...[more]

PMID: 24591854

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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.

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Clinical utility of rivaroxaban in stroke prevention associated with nonvalvular atrial fibrillation - patient considerations.

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Clinical utility of rivaroxaban in stroke prevention associated with nonvalvular atrial fibrillation - patient considerations.

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