Place of Dabigatran in Contemporary Pharmacotherapy

Gums, John G.

doi:10.1592/phco.31.4.335

Cited by 3 publications

(2 citation statements)

References 12 publications

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“…There was a significant difference in study drug discontinuation rates between dabigatran-(21%) and VKA-treated (17%) subjects in RE-LY, which may be explained by the open-label design, as well as higher rates of dyspepsia with dabigatran (possibly attributable to the drug's acid-containing formulation) [13, 48]. While temporary disruption of study drug for clinical indications was allowed in all three trials, prolonged disruption obligated permanent discontinuation of study drug in ROCKET AF, in line with the overall trial design which specified a per protocol on-treatment primary analysis plan.…”

Section: The Phase III Clinical Trials: Resultsmentioning

confidence: 99%

Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban

et al. 2012

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Unlike vitamin K antagonists (VKAs), the new oral anticoagulants (NOACs)—direct thrombin inhibitor, dabigatran, and direct activated factor X inhibitors, rivaroxaban, and apixaban—do not require routine INR monitoring. Compared to VKAs, they possess relatively rapid onset of action and short halflives, but vary in relative degrees of renal excretion as well as interaction with p-glycoprotein membrane transporters and liver cytochrome P450 metabolic enzymes. Recent completed phase III trials comparing NOACs with VKAs for stroke prevention in atrial fibrillation (AF)—the RE-LY, ROCKET AF, and ARISTOTLE trials—demonstrated at least noninferior efficacy, largely driven by significant reductions in haemorrhagic stroke. Major and nonmajor clinically relevant bleeding rates were acceptable compared to VKAs. Of note, the NOACs caused significantly less intracranial haemorrhagic events compared to VKAs, the mechanisms of which are not completely clear. With convenient fixed-dose administration, the NOACs facilitate anticoagulant management in AF in the community, which has hitherto been grossly underutilised. Guidelines should evolve towards simplicity in anticipation of greater use of NOACs among primary care physicians. At the same time, the need for caution with their use in patients with severely impaired renal function should be emphasised.

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Section: The Phase III Clinical Trials: Resultsmentioning

confidence: 99%

Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban

et al. 2012

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“…[21] With the frequency of AF expected to double by 2050, there has been a large push by the medical industry to find alternatives to Warfarin that are cost effective, clinically practical, simple for patients, and free of frequent monitoring requirements. [24] Newer oral anticoagulants have since been introduced as attractive alternatives to Warfarin.…”

Section: Introductionmentioning

confidence: 99%

Trends in the management of atrial fibrillation: A neurologist's perspective

Hedna

Favilla

Guerrero

et al. 2012

Journal of Cardiovascular Disease Research

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Cardiac embolism, primarily from atrial fibrillation (AF), is implicated in a quarter of all ischemic strokes. In the setting of AF, contraindications to traditional therapies can create a clinical dilemma when choosing an agent for secondary stroke prophylaxis. Newer horizons in the medical and surgical management of AF have helped us choose from a wide variety of available therapies, the best possible management. In this article, we review the current trends in AF management including newer oral anticoagulants as well as surgical devices from a neurologist's view.

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Gastrointestinal disorders and dabigatran

Hoffman

Galle

2012

Scandinavian Journal of Gastroenterology

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Anticoagulants play an important role in the prevention and treatment of a variety of acute and chronic thromboembolic disorders such as primary prevention and treatment of venous thromboembolism or prevention of stroke and systemic embolism in atrial fibrillation just to name of few. Within recent years, a promising new oral anticoagulant, the direct thrombin inhibitor dabigatran etexilate (dabigatran) successfully underwent clinical development and has emerged as an alternative to vitamin K antagonists according to a variety of recently revised and updated international guidelines referring to the indication of stroke prevention in atrial fibrillation. Considering the intensive clinical use of vitamin K antagonists in the mentioned indication as well as the widespread and increasing therapeutic need on one hand and the likely availability of a more efficacious alternative with fewer limitations in clinical practice on the other, there is good reason to assume that the use of dabigatran may be broad within the general medical community in the near future. Based on what is currently published in the public domain and clinical trial data it is suggested that dabigatran etexilate is associated with higher rates of dyspeptic symptoms compared to warfarin. Therefore, it is the authors' intent to review and discuss this potential dyspeptic side effect profile of dabigatran and potential counter measures from a gastroenterologist's perspective.

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Place of Dabigatran in Contemporary Pharmacotherapy

Cited by 3 publications

References 12 publications

Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban

Stroke Prevention in Atrial Fibrillation: Understanding the New Oral Anticoagulants Dabigatran, Rivaroxaban, and Apixaban

Trends in the management of atrial fibrillation: A neurologist's perspective

Gastrointestinal disorders and dabigatran

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