Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients

Laliberté, François; Cloutier, Michel; Nelson, Winnie W.; Coleman, Craig I.; Pilon, Dominic; Olson, William H.; Damaraju, C.V.; Schein, Jeffrey; Lefèbvre, Patrick

doi:10.1185/03007995.2014.907140

Cited by 171 publications

(116 citation statements)

References 16 publications

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“…Comparison of separate data for rivaroxaban with warfarin could not be extracted from 2 papers; adjusted HRs between OAC comparisons were lacking in 16; no separate AF data could be extracted from 1 paper with mixed disease states. Finally, 17 observational studies [7][8][9][10][11][12][20][21][22][23][24][25][26][27][28][29][30][31] were included in our analysis, with 3 comparing rivaroxaban versus dabigatran, 9-11 11 comparing rivaroxaban versus Warfarin, 20-27,29-31 and 3 evaluating both comparisons. 7,8,12 Studies with new users and switchers are shown in Table I in the online-only Data Supplement.…”

mentioning

confidence: 99%

Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation

Bai

Deng

Shantsila

et al. 2017

Stroke

119

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T he use of oral anticoagulants (OACs), such as the vitamin K antagonists (eg, warfarin), in patients with atrial fibrillation (AF) results in a significant reduction in stroke, ischemic stroke (IS), and systematic thromboembolism (TE), as well as all-cause mortality, when compared with placebo or control.1 However, warfarin has many limitations, including the necessity for regular anticoagulation monitoring, dietary and drug interactions, and the potential for serious bleeding if anticoagulation is poorly controlled, as reflected by a poor time in therapeutic range. 2 The availability of the non-vitamin K antagonist oral anticoagulants (NOACs) has changed the landscape for stroke prevention in AF, and a meta-analysis of randomized clinical trials (RCTs) by Ruff et al 3 has shown that usual-dose NOACs result in a significant reduction in stroke/TE and mortality with NOACs compared with warfarin, with a trend toward less major bleeding and significantly lower intracranial hemorrhage (ICH). However, RCTs have specific inclusion/ exclusion criteria, have set protocol-based follow-up, and perhaps represent a highly selected and controlled scenario, but still represent the gold standard of testing the effectiveness and safety of an intervention. Based on RCT data, indirect comparisons have been published showing how the different NOACs may perform relative to each other, 4,5 but only a headto-head RCT can definitively assess the relative efficacy and safety of one NOAC against another.When a drug is licensed and used in everyday clinical practice, these drugs are then prescribed to a broad spectrum of Background and Purpose-This study was designed to evaluate the effectiveness and safety of rivaroxaban in real-world practice compared with effectiveness and safety of dabigatran or warfarin for stroke prevention in atrial fibrillation through meta-analyzing observational studies. Methods-Seventeen studies were included after searching in PubMed for studies reporting the comparative effectiveness and safety of rivaroxaban versus dabigatran (n=3), rivaroxaban versus Warfarin (n=11), or both (n=3) for stroke prevention in atrial fibrillation. Results-Overall, the risks of stroke/systematic thromboembolism with rivaroxaban were similar when compared with those with dabigatran (stroke/thromboembolism: hazard ratio, 1.02; 95% confidence interval, 0.91-1.13; I 2 =70.2%, N=5), but were significantly reduced when compared with those with warfarin (hazard ratio, 0.75; 95% confidence interval, 0.64-0.85; I 2 =45.1%, N=9). Major bleeding risk was significantly higher with rivaroxaban than with dabigatran (hazard ratio, 1.38; 95% confidence interval, 1.27-1.49; I 2 =26.1%, N=5), but similar to that with warfarin (hazard ratio, 0.99; 95% confidence interval, 0.91-1.07; I 2 =0.0%, N=6). Rivaroxaban was associated with increased all-cause mortality and gastrointestinal bleeding, but similar risk of acute myocardial infarction and intracranial hemorrhage when compared with dabigatran. When compared with warfarin, rivaroxaban was ass...

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confidence: 99%

Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation

Bai

Deng

Shantsila

et al. 2017

Stroke

119

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“…The baseline period was defined as the 12‐month continuous health plan enrollment period prior to the index date and the observation period was defined as the period from the index date until whichever event of the following occurred first: end of 12 months of follow‐up, end of continuous health plan enrollment, end of data availability, end of continuous treatment (applied for the continued cohort only), or re‐initiation of oral anticoagulants (applied for the discontinued cohort only). Variables measured during the baseline period include demographics, year of index date, type of index VTE (DVT, PE, or both), VTE identified in the hospital or outpatient/ER, time from first VTE to first rivaroxaban dispensing, Quan‐Charlson comorbidity index (CCI), RIETE bleeding score,20 baseline healthcare resource utilization and costs, risk factors for VTE (including risk factors from the ACCP Evidence‐Based Clinical Practice Guidelines list)21 and bleeding 15…”

Section: Methodsmentioning

confidence: 99%

“…Rivaroxaban, an oral direct factor Xa inhibitor anticoagulant indicated for acute and extended treatment of VTE,13 has been demonstrated as a viable alternative therapy to traditional vitamin K antagonist (VKA) therapy with advantages of minimal drug and food interactions and no requirement for routine coagulation monitoring 13, 14, 15. Findings from a pair of phase III clinical trials have shown that extended treatment with rivaroxaban for an additional 6–12 months is safe and effective to decrease VTE recurrence risk in patients with VTE who have previously completed 6 or 12 months of anticoagulant therapy 14, 16.…”

Section: Introductionmentioning

confidence: 99%

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

Berger

Seheult

Laliberté

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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Essentials Clinical trials demonstrated the gain of extended anticoagulation among patients with VTE.In a real‐world setting, we evaluated outcomes of extended rivaroxaban use for unprovoked VTE.Extended rivaroxaban treatment lowered the risk of recurrent VTE among unprovoked VTE patients.Extended rivaroxaban treatment was not associated with increased risk of major bleeding. BackgroundRandomized trial data demonstrate the gain of extended duration anticoagulation in patients with venous thromboembolic events (VTE); however, real‐world data are limited.ObjectivesAssess the risk of recurrent VTE and major bleeding in a real‐world setting of patients who experienced unprovoked VTE and received extended treatment with rivaroxaban.Methods US claims databases (February 2011–April 2015) were used in this retrospective study. The study population included adult patients initiated on rivaroxaban within 7 days after their first unprovoked VTE (ie, deep vein thrombosis, pulmonary embolism) and received ≥3 months continuous rivaroxaban treatment (index date: end of 3‐month treatment). Patients who were treated beyond 3 months formed the continued cohort and the remainder formed the discontinued cohort (ie, discontinued at 3 months). Adjusted Kaplan‐Meier rates for recurrent VTE and major bleeding events were compared between cohorts with confounders being controlled through a propensity score weighting approach.ResultsPatients in the continued cohort (N = 3763) had significantly lower rates of recurrent VTE than those who discontinued (N = 1051): 0.57% vs 1.19% (P = .042), 1.07% vs 2.10% (P = .017), and 1.45% vs 2.60% (P = .023) at 3, 6, and 12 months, respectively. No significant differences in the rate of major bleeding were observed between cohorts. A sensitivity analysis among unprovoked VTE patients receiving rivaroxaban for ≥6 months showed similar results.ConclusionsContinued rivaroxaban treatment beyond an initial 3‐ or 6‐month treatment period significantly lowered the risk of recurrent VTE without a significant increase of major bleeding, compared to treatment discontinued at 3 or 6 months.

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“…Данные реальной клинической практики подтвер-ждают эффективность и хороший профиль безопасности ривароксабана, который демонстрирует значительно бо-лее высокие показатели приверженности к лечению в сравнении с варфарином [43]. В Дрезденском регистре применения НОАК у больных с ФП большие крово-течения при приеме ривароксабана 1 р/д развивались с частотой 3,1% в год [44], а 81,5% пациентов про-должали лечение этим антикоагулянтом при среднем периоде наблюдения 544 дня [45].…”

Section: использование ривароксабана у больных с фибрилляцией предсерunclassified

“…Поскольку долгосрочные исходы терапии пациентов с ФП, веро-ятно, будут зависеть от различий в приверженности к различным режимам приема пероральных антикоа-гулянтов, важно оценить предпочтение и возможное влияние препаратов на исходы при их приеме 1 или 2 р/д. Сообщалось о том, что больные с ФП, принимав-шие ривароксабан, отличались значительно более вы-соким уровнем приверженности (частоты регулярно-го соблюдения назначенного режима повторного прие-ма препаратов) в течение 3-х и 6-месячных периодов наблюдения по сравнению с показателями при лечении варфарином -84,5 против 75,6% и 81,5 против 68,3%, соответственно (р<0,0001 для обоих сравне-ний) [43]. По данным ретроспективного когортного ана-лиза антикоагулянтной терапии в США, включавшего более 32000 пациентов с ФП, получавших ривароксабан или варфарин, первый из препаратов больные чаще принимали без длительных перерывов и реже отка-зывались от лечения по сравнению с приемом варфа-рина [50].…”

Section: оNce-daily Anticoagulant In Atrial Fibrillationunclassified

Adherence to the Use of New Oral Anticoagulants in Patients With Atrial Fibrillation – the Way to Solve the Problem of Efficacy and Safety of Treatment

Канорский

2017

Racionalʹnaâ farmakoterapiâ v kardiologii

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Приверженность к приему новых пероральных антикоагулянтов у больных с фибрилляцией предсердий -путь к решению проблемы эффективности и безопасности леченияСергей Григорьевич Канорский* Кубанский государственный медицинский университет Россия, 350063, Краснодар, ул. Седина, 4 Фибрилляция предсердий (ФП) увеличивает риск развития инсульта, поэтому долгосрочная антикоагулянтная терапия является стандартом лечения абсолютного большинства пациентов с этой аритмией. Варианты антикоагулянтной терапии включают антагонисты витамина К, та-кие как варфарин, польза которых давно установлена, но имеющие ряд недостатков, а также их альтернативу -пероральные антикоагулян-ты -не антагонисты витамина К, рекомендуемые для лечения пациентов с ФП при умеренном или высоком риске развития инсульта. При-верженность к фармакотерапии важна для долгосрочной эффективности любых препаратов, однако в «реальном мире» у пациентов с ФП следует ожидать относительно низкие уровни приверженности к лекарственным средствам по сравнению с клиническими исследованиями. Опыт в нескольких областях терапии, включая лечение сердечно-сосудистых заболеваний, показывает, что низкая приверженность к посто-янному приему лекарств -обычное явление. Однако здесь могут оказаться выгодными простые схемы дозирования, поскольку долгосроч-ные исходы при ФП, вероятно, будут зависеть от приверженности к лечению. Ривароксабан можно назначать в фиксированных дозах без рутинного контроля коагуляции, а исследования III фазы и реальная клиническая практика продемонстрировали его безопасность и эффек-тивность у больных с ФП, включая пожилых людей и пациентов с сопутствующими заболеваниями. Прием перорального антикоагулянта не антагониста витамина К, в частности ривароксабана, 1 раз в день потенциально способен улучшать приверженность к терапии и результаты профилактики инсульта у пациентов с ФП.Ключевые слова: дозирование 1 раз в день, приверженность к лечению, антикоагулянты, фибрилляция предсердий, предупреждение ин-сульта, ривароксабан. Atrial fibrillation (AF) increases the risk of stroke, therefore long-term anticoagulant therapy is the standard for the treatment of the absolute majority of patients with this arrhythmia. Variants of anticoagulant therapy include vitamin K antagonists, such as warfarin, whose benefits are long established, but have a number of disadvantages, as well as their alternative -non-vitamin K antagonists -oral anticoagulants, recommended for the treatment of patients with AF with moderate or high risk of stroke. Adherence to pharmacotherapy is important for the long-term effectiveness of any medication; however, in the "real world" in patients with AF relatively low levels of adherence to drugs compared with clinical studies are expected. Experience in several areas of therapy, including the treatment of cardiovascular disease, shows that a low adherence to a constant intake of medications is common. However, in this respect, simple dosing regimens may be beneficial, since long-term outcomes in AF are likely to depend on adherence to treatment...

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Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients

Cited by 171 publications

References 16 publications

Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation

Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

Adherence to the Use of New Oral Anticoagulants in Patients With Atrial Fibrillation – the Way to Solve the Problem of Efficacy and Safety of Treatment

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