Dabigatran Versus Warfarin for Atrial Fibrillation in Real-World Clinical Practice

Romanelli, Robert J.; Nolting, Laura; Dolginsky, Marina; Kym, Eunice; Orrico, Kathleen B.

doi:10.1161/circoutcomes.115.002369

Cited by 83 publications

(66 citation statements)

References 31 publications

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“…A meta-analysis of seven observational studies, comparing dabigatran with warfarin, indicated that the ability of dabigatran to prevent ischemic stroke and bleeding outcomes is comparable to that of warfarin, which is consistent with the data obtained from the RE-LY trial [9]. These findings do not differ between the Japanese patients and the U.S. and European cohorts.…”

Section: Discussionsupporting

confidence: 78%

Effectiveness and safety of dabigatran versus warfarin in “real‐world” Japanese patients with atrial fibrillation: A single‐center observational study

Naganuma

Shiga

Nagao

et al. 2016

Journal of Arrhythmia

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BackgroundIn “real-world” practice, anticoagulant therapy is indicated for patients whose clinical profiles are not addressed in randomized clinical trials. We assessed the effectiveness and safety of dabigatran versus warfarin in “real-world” Japanese patients with non-valvular atrial fibrillation (NVAF).MethodsAmong 613 NVAF patients who initiated dabigatran or warfarin therapy during the period between 2011 and 2013, 362 patients were included in the study after propensity score adjustment. The median follow-up period was 1.3 years. The effectiveness and safety outcomes were thromboembolism and major bleeding, respectively.ResultsThe propensity-matched hazard ratios of thromboembolism and major bleeding with dabigatran were 1.03 (95% CI: 0.12-8.04, p=0.971) and 0.15 (95% CI: 0.01–0.90, p=0.037), respectively.ConclusionsThe ability of dabigatran to prevent thromboembolism is comparable to that of warfarin; however, the major bleeding rate is lower with dabigatran in “real-world” NVAF patients.

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Section: Discussionsupporting

confidence: 78%

Effectiveness and safety of dabigatran versus warfarin in “real‐world” Japanese patients with atrial fibrillation: A single‐center observational study

Naganuma

Shiga

Nagao

et al. 2016

Journal of Arrhythmia

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“…All studies documenting this protective effect relate to dabigatran, whereas the only matched cohort study reporting no statistically significant protective effect on ICH (HR 1.17, 95 % CI 0.66–2.05) compared rivaroxaban with warfarin. The latest meta-analysis of observational studies on dabigatran (not included in our analysis) corroborated these findings by pooling seven cohort studies (HR 0.44, 95 % CI 0.34–0.59, I 2 = 64 % for dabigatran 150 mg) [77]. The mechanism behind a reduced ICH risk is still largely unknown, although in vivo studies pointed out that the potential anti-inflammatory properties of dabigatran may partially explain the observed clinical benefit [78, 79].…”

Section: Discussionsupporting

confidence: 58%

Risk–Benefit Profile of Direct-Acting Oral Anticoagulants in Established Therapeutic Indications: An Overview of Systematic Reviews and Observational Studies

et al. 2016

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Since 2008, the direct-acting oral anticoagulants (DOACs) have expanded the therapeutic options of cardiovascular diseases with recognized clinical and epidemiological impact, such as non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE), and also in the preventive setting of orthopedic surgical patients. The large body of evidence, not only from pivotal clinical trials but also from ‘real-world’ postmarketing observational findings (e.g. analytical epidemiological studies and registry data) gathered to date allow for a first attempt at verifying a posteriori whether or not the pharmacological advantages of the DOACs actually translate into therapeutic innovation, with relevant implications for clinicians, regulators and patients. This review aims to synthesize the risk–benefit profile of DOACs in the aforementioned consolidated indications through an ‘evidence summary’ approach gathering the existent evidence-based data, particularly systematic reviews with meta-analyses of randomized controlled trials, as well as observational studies, comparing DOACs with vitamin K antagonists. Clinical evidence will be discussed and compared with major international guidelines to identify whether an update is needed. Controversial clinically relevant safety issues will be also examined in order to highlight current challenges and unsettled questions (e.g. actual bleeding risk in susceptible populations). It is anticipated that the large number of publications on NVAF or VTE (44 systematic reviews with meta-analyses and 12 observational studies retained in our analysis) suggests the potential existence of overlapping studies and calls for common criteria to qualitatively and quantitatively assess discordances, thus guiding future research.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0464-3) contains supplementary material, which is available to authorized users.

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“…Post-marketing studies are non-randomized, retrospective studies, but reflect the real-world clinical practice. These studies have also demonstrated similar findings (Romanelli et al, 2016;Villines and Peacok, 2016). In unselected population, the first prospective, observational, international study showed low stroke rates and bleeding in patients with non-valvular AF in use of rivaroxaban (Camm et al, 2015).…”

Section: Effectiveness and Safety Of Noacssupporting

confidence: 82%

Pharmacological profile of non-vitamin K antagonist oral anticoagulants

Silva¹

2017

Afr. J. Pharm. Pharmacol.

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female patients, oral anticoagulants are recommended, and considering shared decision between doctor and patient. However, they are contraindicated in patients with mechanical prosthetic valve and in patients with moderate-to-severe mitral stenosis and atrial fibrillation. They have also been approved for prevention and treatment of deep vein thrombosis and pulmonary embolism. Dabigatran, a direct thrombin inhibitor, was the first to be approved, followed by the factor Xa inhibitors, rivaroxaban, apixaban, and recently, in 2015, edoxaban. They have advantages such as the use of fixed-dose, with infrequent drug interaction, rapid onset of action and do not require monitoring of their anticoagulant action. Nonetheless, they have different half-lives, the need for dose adjustment according to renal function, weight and age of the patient. Its use in pregnant women and children or adolescents is not well established. There are also peculiarities about the risks of bleeding, effects on coagulation tests and specific antidotes. Through this review we discuss the pharmacokinetics and pharmacodynamics characteristics of direct oral anticoagulants, its indications, interactions and contraindications. Analysis of its efficacy, safety and risk-benefit ratio will also be addressed.

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Dabigatran Versus Warfarin for Atrial Fibrillation in Real-World Clinical Practice

Cited by 83 publications

References 31 publications

Effectiveness and safety of dabigatran versus warfarin in “real‐world” Japanese patients with atrial fibrillation: A single‐center observational study

Effectiveness and safety of dabigatran versus warfarin in “real‐world” Japanese patients with atrial fibrillation: A single‐center observational study

Risk–Benefit Profile of Direct-Acting Oral Anticoagulants in Established Therapeutic Indications: An Overview of Systematic Reviews and Observational Studies

Pharmacological profile of non-vitamin K antagonist oral anticoagulants

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