Efficacy and safety of rivaroxaban in real-life patients with atrial fibrillation

Barón-Esquivias, Gonzalo; Fernández-Avilés, Francisco; Atienza, Felipe; Pueyo, Pablo Pastor; Toro, Rocío; Fernández, Marcelo Sanmartín

doi:10.1586/14779072.2015.1026259

Cited by 8 publications

(4 citation statements)

References 81 publications

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“…8,9 Several recent studies of DOACs in ‘real-world’ clinical settings have shown similar efficacy and safety to the RCTs, but these were not designed to investigate interacting drugs. 10–15 Some data are available on clinical outcomes of specific PK-DDIs with DOACs but the evidence is conflicting. For example, amiodarone has been associated with increased odds of bleeding in patients taking rivaroxaban, 16 and patients who had major bleeds on rivaroxaban appeared twice as likely to be taking a P-gp inhibitor with or without a CYP3A inhibitor.…”

Section: Introductionmentioning

confidence: 99%

Potential drug–drug interactions with direct oral anticoagulants in elderly hospitalized patients

Forbes

Polasek

2017

Therapeutic Advances in Drug Safety

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Section: Introductionmentioning

confidence: 99%

Potential drug–drug interactions with direct oral anticoagulants in elderly hospitalized patients

Forbes

Polasek

2017

Therapeutic Advances in Drug Safety

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“…The ROCKET AF trial represents a landmark trial establishing the use of rivaroxaban as an effective and well-tolerated alternative oral anticoagulant to warfarin in patients with AF. Recent analyses have reinforced the robustness of the results of the ROCKET AF trial and suggest that the results hold up well in real life clinical practice [Martinez-Rubio et al 2014; Baron-Esquivias et al 2015]. The results from the ROCKET AF trial parallel those from other major trials establishing the use of NOACs in AF patients [Connolly et al 2009; Granger et al 2011; Giugliano et al 2013].…”

Section: Resultsmentioning

confidence: 86%

Primary and key secondary results from the ROCKET AF trial, and their implications on clinical practice

Shah

Patel

2016

Therapeutic Advances in Cardiovascular Disease

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Background:The safety and efficacy of the oral anticoagulant rivaroxaban were studied in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF trial). A number of subanalyses of the ROCKET AF trial have subsequently analyzed the use of rivaroxaban in special patient populations. Methods: The outcomes of the ROCKET AF trial were reviewed. The use of rivaroxaban in higher risk populations, as determined by the presence of co-morbidities included in the CHADS2 criteria, was analyzed. Requirements for dose adjustment in patients with renal impairment and in East Asian patients were described. Finally, clinical management challenges, including interruptions in therapy, drug discontinuation, management of bleeding events, drug interactions, and management of patients requiring cardioversion/ablation were reviewed. Results: Rivaroxaban is efficacious in high-risk populations, including elderly patients, patients with diabetes, heart failure, history of stroke, prior myocardial infarction, or peripheral arterial disease (PAD). Patients with PAD have a higher risk of bleeding with rivaroxaban compared with warfarin. East Asian populations do not require a dose adjustment for rivaroxaban, while a reduced dose of 15 mg daily is required for patients with moderate renal impairment. Rivaroxaban remains effective with temporary interruptions in therapy and in patients requiring cardioversion/ablation. Rates of major bleeding and subsequent outcomes were similar in patients on warfarin and rivaroxaban, although rates of gastrointestinal bleeding were higher with rivaroxaban. Concurrent use of antiarrhythmic therapy was not associated with adverse outcomes. Conclusions: Rivaroxaban represents an efficacious alternative to warfarin in high-risk patients with AF. Dose adjustment is required for patients with moderate renal impairment. Rivaroxaban can be used safely in a number of challenging clinical management scenarios although the concurrent use of amiodarone requires more study.

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“…This approval was based on the ROCKET-AF results [59]. Patients included in clinical trials usually differ somewhat from those attended in daily clinical practice [94,95]. Consequently, studies performed in the clinical practice setting are very relevant.…”

Section: Efficacy and Safety Of Rivaroxaban In 'Real-life' Patients Witmentioning

confidence: 99%

Atrial fibrillation and chronic kidney disease: focus on rivaroxaban

Barrios

Górriz

2015

J. Comp. Eff. Res.

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Renal insufficiency increases the risk of stroke and bleeding in atrial fibrillation patients. Although vitamin K antagonists reduce the risk of stroke in patients with moderate renal dysfunction, this observation is less clear in patients with renal impairment. Moreover, the risk of bleeding with vitamin K antagonists increases as renal function worsens. Maintaining international normalized ratio values within therapeutic targets is more difficult in patients with renal dysfunction, and those agents may cause warfarin-related nephropathy and vascular calcification. Rivaroxaban is the only nonvitamin K oral anticoagulant with a dose specifically tested in patients with moderate renal insufficiency. Rivaroxaban is effective for the prevention of stroke in atrial fibrillation patients with moderate renal dysfunction, with a lower risk of intracranial and fatal bleeding.

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Efficacy and safety of rivaroxaban in real-life patients with atrial fibrillation

Cited by 8 publications

References 81 publications

Potential drug–drug interactions with direct oral anticoagulants in elderly hospitalized patients

Potential drug–drug interactions with direct oral anticoagulants in elderly hospitalized patients

Primary and key secondary results from the ROCKET AF trial, and their implications on clinical practice

Atrial fibrillation and chronic kidney disease: focus on rivaroxaban

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