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New anticoagulants for the prevention of venous thromboembolism  [cached]
Cecilia Becattini,Alessandra Lignani,Giancarlo Agnelli
Drug Design, Development and Therapy , 2010,
Abstract: Cecilia Becattini, Alessandra Lignani, Giancarlo AgnelliInternal and Cardiovascular Medicine and Stroke Unit, University of Perugia, ItalyAbstract: Anticoagulant drugs have an essential role in the prevention and treatment of thromboembolic diseases. Currently available anticoagulants substantially reduce the incidence of thromboembolic events in a number of clinical conditions. However, these agents have limitations that strengthen the case for the development of new anticoagulants. An ideal anticoagulant should be at least as effective as those currently in use, as well as safe, simple to use, and widely applicable. The majority of new anticoagulants currently under investigation are small molecules with a selective and direct anti-Xa or antithrombin action, allowing oral administration in fixed doses. These new agents are in different phases of clinical development. The anti-Xa agent rivaroxaban and the antithrombin agent dabigatran are already available for the prophylaxis of venous thromboembolism in some countries. Apixaban is in an advanced phase of clinical development and several anti-Xa agents are currently approaching phase III clinical trials. Promising results in terms of efficacy and safety profiles have been obtained with these agents in different clinical conditions. Differences in pharmacokinetics and pharmacodynamics could offer the potential for individualized anticoagulant therapies in the near future.Keywords: anticoagulant therapy, antithrombotic therapy, anticoagulants, direct thrombin inhibitors, factor Xa inhibitors
New anticoagulants for the prevention of venous thromboembolism
Cecilia Becattini, Alessandra Lignani, Giancarlo Agnelli
Drug Design, Development and Therapy , 2010, DOI: http://dx.doi.org/10.2147/DDDT.S6074
Abstract: nticoagulants for the prevention of venous thromboembolism Review (7731) Total Article Views Authors: Cecilia Becattini, Alessandra Lignani, Giancarlo Agnelli Published Date April 2010 Volume 2010:4 Pages 49 - 60 DOI: http://dx.doi.org/10.2147/DDDT.S6074 Cecilia Becattini, Alessandra Lignani, Giancarlo Agnelli Internal and Cardiovascular Medicine and Stroke Unit, University of Perugia, Italy Abstract: Anticoagulant drugs have an essential role in the prevention and treatment of thromboembolic diseases. Currently available anticoagulants substantially reduce the incidence of thromboembolic events in a number of clinical conditions. However, these agents have limitations that strengthen the case for the development of new anticoagulants. An ideal anticoagulant should be at least as effective as those currently in use, as well as safe, simple to use, and widely applicable. The majority of new anticoagulants currently under investigation are small molecules with a selective and direct anti-Xa or antithrombin action, allowing oral administration in fixed doses. These new agents are in different phases of clinical development. The anti-Xa agent rivaroxaban and the antithrombin agent dabigatran are already available for the prophylaxis of venous thromboembolism in some countries. Apixaban is in an advanced phase of clinical development and several anti-Xa agents are currently approaching phase III clinical trials. Promising results in terms of efficacy and safety profiles have been obtained with these agents in different clinical conditions. Differences in pharmacokinetics and pharmacodynamics could offer the potential for individualized anticoagulant therapies in the near future.
Differentiation of parenteral anticoagulants in the prevention and treatment of venous thromboembolism
Jawed Fareed, Cafer Adiguzel, Indermohan Thethi
Thrombosis Journal , 2011, DOI: 10.1186/1477-9560-9-5
Abstract: MEDLINE and EMBASE databases were searched to identify relevant original articles.Low-molecular-weight heparins have nearly replaced unfractionated heparin as the gold standard antithrombotic agent. Low-molecular-weight heparins currently available in the US are enoxaparin, dalteparin, and tinzaparin. Each low-molecular-weight heparin is a distinct pharmacological entity with different licensed indications and available clinical evidence. Enoxaparin is the only low-molecular-weight heparin that is licensed for both venous thromboembolism prophylaxis and treatment. Enoxaparin also has the largest body of clinical evidence supporting its use across the spectrum of venous thromboembolism management and has been used as the reference standard comparator anticoagulant in trials of new anticoagulants. As well as novel oral anticoagulant agents, biosimilar and/or generic low-molecular-weight heparins are now commercially available. Despite similar anticoagulant properties, studies report differences between the branded and biosimilar and/or generic agents and further clinical studies are required to support the use of biosimilar low-molecular-weight heparins. The newer parenteral anticoagulant, fondaparinux, is now also licensed for venous thromboembolism prophylaxis in surgical patients and the treatment of acute deep-vein thrombosis; clinical experience with this anticoagulant is expanding.Parenteral anticoagulants should be prescribed in accordance with recommended dose regimens for each clinical indication, based on the available clinical evidence for each agent to assure optimal safety and efficacy.Venous thromboembolism (VTE) is a common disease that occurs in hospitalized surgical and medical patients and in the community [1]. In 2003, over 12 million medical and surgical patients in the Nationwide Inpatient Sample, comprising 31% of all US hospital discharges for that year, were at risk of VTE and warranted thromboprophylaxis [2]. The risk of VTE can persist for a
The prevention and treatment of venous thromboembolism with LMWHs and new anticoagulants
Andrew D Blann, Chee W Khoo
Vascular Health and Risk Management , 2009, DOI: http://dx.doi.org/10.2147/VHRM.S4621
Abstract: evention and treatment of venous thromboembolism with LMWHs and new anticoagulants Review (4750) Total Article Views Authors: Andrew D Blann, Chee W Khoo Published Date September 2009 Volume 2009:5 Pages 693 - 704 DOI: http://dx.doi.org/10.2147/VHRM.S4621 Andrew D Blann, Chee W Khoo University Department of Medicine, City Hospital, Birmingham, UK Abstract: As the risk factors for thrombosis are becoming better understood, so is the need for anticoagulation. The inherent difficulties with warfarin are such that a low-molecular-weight heparin (LMWH) is often the key therapeutic. However, there are several different species of LMWH available to the practitioner, which leads to the need for an objective guide. New agents are coming onto the marketplace, and these may supersede both warfarin and the heparins. The current report will review the biochemistry and pharmacology of different LWMHs and identify which are more suitable for the different presentations of venous thromboembolism. It will conclude with a brief synopsis of new agents which may supersede warfarin and heparin.
Current Status of New Anticoagulants in the Management of Venous Thromboembolism  [PDF]
Roberto C. Montoya,Ajeet Gajra
Advances in Hematology , 2012, DOI: 10.1155/2012/856341
Abstract: Venous Thromboembolism, manifested as deep venous thrombosis and pulmonary embolism, is a common problem associated with significant morbidity, mortality, and resource expenditure. Unfractionated heparin, low-molecular-weight heparin, and vitamin K antagonists are the most common treatment and prophylaxis, and have demonstrated their efficacy in a vast number of previous studies. Despite their broad use, these agents have important limitations that have led to the development of new drugs in a bid to overcome the disadvantages of the old ones without decreasing their therapeutic effect. These novel medications, some approved and others in different stages of development, include direct thrombin inhibitors like dabigatran etexilate, and direct activated factor X inhibitors like rivaroxaban. The current paper will review the characteristics, clinical trial results, and current and potential therapeutic uses of these new agents with a focus on the categories of direct thrombin inhibitors and activated factor X inhibitors. Introduction Venous thromboembolism (VTE) is a disease that encompasses the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE). Despite being a preventable problem, VTE has a high prevalence. Without prophylaxis, the incidence of hospital-acquired DVT is approximately 10% to 40% among medical or general surgical patients and 40% to 60% following major orthopedic surgery. Also, approximately 10% of hospital deaths are caused by PE [1]. The effectiveness of primary thromboprophylaxis, to reduce the frequency of DVT and PE, is supported by well-established scientific evidence. Heparin products that include unfractionated heparin (UH), low-molecular-weight heparin (LMWH), and vitamin K antagonists (VKA) are the most commonly used prophylactic treatments and they have demonstrated good efficacy and cost effectiveness. While these agents have been used for many years, each class has its drawbacks and are far from being “ideal” anticoagulants. For this reason, the search for new anticoagulants continues and these efforts have been concentrated on drugs focusing on two targets: thrombin and activated factor X (FXa). These novel agents, currently approved or under evaluation for management of VTE, act directly on the active sites of thrombin or FXa and they include the direct thrombin inhibitor (DTI) Dabigatran Etexilate and the direct FXa inhibitors: rivaroxaban, apixaban, edoxaban, and betrixaban. 1. Direct Thrombin Inhibitors DTIs are agents that neutralize thrombin directly by binding to its active catalytic site and blocking
The prevention and treatment of venous thromboembolism with LMWHs and new anticoagulants  [cached]
Andrew D Blann,Chee W Khoo
Vascular Health and Risk Management , 2009,
Abstract: Andrew D Blann, Chee W KhooUniversity Department of Medicine, City Hospital, Birmingham, UKAbstract: As the risk factors for thrombosis are becoming better understood, so is the need for anticoagulation. The inherent difficulties with warfarin are such that a low-molecular-weight heparin (LMWH) is often the key therapeutic. However, there are several different species of LMWH available to the practitioner, which leads to the need for an objective guide. New agents are coming onto the marketplace, and these may supersede both warfarin and the heparins. The current report will review the biochemistry and pharmacology of different LWMHs and identify which are more suitable for the different presentations of venous thromboembolism. It will conclude with a brief synopsis of new agents which may supersede warfarin and heparin.Keywords: thrombosis, warfarin, heparin, anticoagulation
Potential role of new anticoagulants for prevention and treatment of venous thromboembolism in cancer patients  [cached]
Gómez-Outes A,Suárez-Gea ML,Lecumberri R,Terleira-Fernández AI
Vascular Health and Risk Management , 2013,
Abstract: Antonio Gómez-Outes,1 M Luisa Suárez-Gea,1 Ramón Lecumberri,2 Ana Isabel Terleira-Fernández,3,4 Emilio Vargas-Castrillón,3,4 Eduardo Rocha51Division of Pharmacology and Clinical Evaluation, Medicines for Human Use, Spanish Agency for Medicines and Medical Devices, Madrid, 2Department of Hematology, University Clinic of Navarra, Pamplona, 3Department of Clinical Pharmacology, Hospital Clínico, Madrid, 4Department of Pharmacology, Universidad Complutense, Madrid, 5Department of Hematology, School of Medicine, University of Navarra, Pamplona, SpainAbstract: Venous thromboembolism (VTE), encompassing deep vein thrombosis and pulmonary embolism, represents a major cause of morbidity and mortality in patients with cancer. Low molecular weight heparins are the preferred option for anticoagulation in cancer patients according to current clinical practice guidelines. Fondaparinux may also have a place in prevention of VTE in hospitalized cancer patients with additional risk factors and for initial treatment of VTE. Although low molecular weight heparins and fondaparinux are effective and safe, they require daily subcutaneous administration, which may be problematic for many patients, particularly if long-term treatment is needed. Studying anticoagulant therapy in oncology patients is challenging because this patient group has an increased risk of VTE and bleeding during anticoagulant therapy compared with the population without cancer. Risk factors for increased VTE and bleeding risk in these patients include concomitant treatments (surgery, chemotherapy, placement of central venous catheters, radiotherapy, hormonal therapy, angiogenesis inhibitors, antiplatelet drugs), supportive therapies (ie, steroids, blood transfusion, white blood cell growth factors, and erythropoiesis-stimulating agents), and tumor-related factors (local vessel damage and invasion, abnormalities in platelet function, and number). New anticoagulants in development for prophylaxis and treatment of VTE include parenteral compounds for once-daily administration (ie, semuloparin) or once-weekly dosing (ie, idraparinux and idrabiotaparinux), as well as orally active compounds (ie, dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban). In the present review, we discuss the pharmacology of the new anticoagulants, the results of clinical trials testing these new compounds in VTE, with special emphasis on studies that included cancer patients, and their potential advantages and drawbacks compared with existing therapies.Keywords: anticoagulants, venous thromboembolism, cancer, dabigatran, apixab
Efficacy and safety of new oral anticoagulants in prophylaxis and treatment of venous thromboembolism  [cached]
Luca Masotti,Cecilia Becattini,Roberto Cappelli,Giancarlo Landini
Reviews in Health Care , 2011, DOI: 10.7175/rhc.14117-26
Abstract: One of the main innovation emerged in recent years in the field of venous thromboembolism (VTE) has been represented by the clinical development and marketing of new oral anticoagulant agents used for prophylaxis and acute treatment. These drugs are represented by direct thrombin inhibitors (anti-factor IIa) and the direct inhibitors of activated factor X (anti-Xa). The main achievement of these new agents is represented by their ease of use without laboratory monitoring or dose adjustment. Dabigatran (anti-factor IIa), rivaroxaban, and apixaban (anti-Xa) are in advanced phase of clinical development with concluded phase III trials. Up to now the results of efficacy and safety of phase III clinical trials are available, while phase IV studies are currently ongoing. Overall, the phase III clinical trials showed the non inferiority of new oral anticoagulants in VTE prophylaxis of patients undergone to major orthopedic surgery, such as hip and knee arthroplasty, compared to conventional prophylaxis represented by subcutaneous low molecular weight heparin with similar safety. Moreover dabigatran has shown to be not inferior when compared to warfarin for the prevention of six months VTE recurrences, with a significative lower incidence of bleedings. Awaiting the results of many other ongoing phase III trials, since now it is possible to think that, in the next future, new oral anticoagulants will be widely diffused in clinical practice for their ease of use and feasibility. In this review the Authors analyse the available results of phase III clinical trials for dabigatran, rivaroxaban and apixaban, focusing on the antithrombotic endpoints for prevention and treatment of VTE and the bleeding risk. Moreover synthesis of ongoing trials will be displayed.
Management of Venous Thromboembolism in Patients with Advanced Gastrointestinal Cancers: What Is the Role of Novel Oral Anticoagulants?  [PDF]
Ludmila Katherine Martin,Tanios Bekaii-Saab
Thrombosis , 2012, DOI: 10.1155/2012/758385
Abstract: Venous thromboembolism (VTE) is a frequent complication of gastrointestinal cancers that increases morbidity and may impact mortality. Low-molecular-weight heparins (LMWHs) and vitamin K antagonists (VKAs) are standard anticoagulation options for the ambulatory gastrointestinal cancer patient with VTE, but both of these agents are challenging to use for various reasons. Novel oral anticoagulants (NOAs) are new, orally available anticoagulants designed to be easier to administer with more reliable pharmacokinetics that eliminate the need for frequent monitoring of various laboratory parameters. This paper reviews the existing efficacy and safety data for the use of NOAs dabigatran etexilate, rivaroxaban, and apixaban and discusses the potential role of these agents in the management of gastrointestinal cancer-related VTE.
Novos anticoagulantes orais no tromboembolismo venoso e fibrilha o auricular New oral anticoagulants in the treatment of venous thromboembolism and atrial fibrillation  [cached]
Luís Silvestre,Augusto Ministro,Ana Evangelista,Luís Mendes Pedro
Angiologia e Cirurgia Vascular , 2012,
Abstract: Os antagonistas da vitamina K foram, durante mais de 50 anos, os únicos anticoagulantes orais disponiveis. A imprevisibilidade da farmacocinética e farmacodinamica desta classe de fármacos, responsável pela dificuldade na sua utiliza o, conduziu à necessidade do desenvolvimento de novas moléculas anticoagulantes. Est o actualmente diponíveis os resultados dos estudos de novos anticoagulantes orais no tromboembolismo venoso e na fibrilha o auricular, que se revêem neste trabalho. For more than 50 years, vitamin K antagonists were the only oral anticoagulants available. The unpredictability of its pharmacokinetics and pharmacodynamics, responsible for its difficult clinical management, has raised the need of new anticoagulants. Results of trials involving the new anticoagulants in venous thromboembolism and atrial fibrillation are now available and reviewed in this paper.
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