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Edoxaban in the Evolving Scenario of Non Vitamin K Antagonist Oral Anticoagulants Imputed Placebo Analysis and Multiple Treatment Comparisons  [PDF]
Paolo Verdecchia, Fabio Angeli, Gregory Y. H. Lip, Gianpaolo Reboldi
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0100478
Abstract: Background Edoxaban recently proved non-inferior to warfarin for prevention of thromboembolism in patients with non-valvular atrial fibrillation (AF). We conducted an imputed-placebo analysis with estimates of the proportion of warfarin effect preserved by each non vitamin K antagonist oral anticoagulant (NOAC) and indirect comparisons between edoxaban and different NOACs. Methods and Findings We performed a literature search (up to January 2014), clinical trials registers, conference proceedings, and websites of regulatory agencies. We selected non-inferiority randomised controlled phase III trials of dabigatran, rivaroxaban, apixaban and edoxaban compared with adjusted-dose warfarin in non-valvular AF. Compared to imputed placebo, all NOACs reduced the risk of stroke (ORs between 0.24 and 0.42, all p<0.001) and all-cause mortality (ORs between 0.55 and 0.59, all p<0.05). Edoxaban 30 mg and 60 mg preserved 87% and 112%, respectively, of the protective effect of warfarin on stroke, and 133% and 121%, respectively, of the protective effect of warfarin on all-cause mortality. The risk of primary outcome (stroke/systemic embolism), all strokes and ischemic strokes was significantly higher with edoxaban 30 mg than dabigatran 150 mg and apixaban. There were no significant differences between edoxaban 60 mg and other NOACs for all efficacy outcomes except stroke, which was higher with edoxaban 60 mg than dabigatran 150 mg. The risk of major bleedings was lower with edoxaban 30 mg than any other NOAC, odds ratios (ORs) ranging between 0.45 and 0.67 (all p<0.001). Conclusions This study suggests that all NOACs preserve a substantial or even larger proportion of the protective warfarin effect on stroke and all-cause mortality. Edoxaban 30 mg is associated with a definitely lower risk of major bleedings than other NOACs. This is counterbalanced by a lower efficacy in the prevention of thromboembolism, although with a final benefit on all-cause mortality.
Efficacy of therapy with indirect anticoagulants: role of the foodstuff vitamin K contents  [cached]
A.P. Momot,O.V. Bespalova,E.N. Vorobyova
Rational Pharmacotherapy in Cardiology , 2006,
Abstract: The anticoagulants of indirect action during many years serve drugs of basic prophylaxis and therapy of thromboembolic episodes at cardiovascular, neurological, oncology, orthopaedic and other diseases, after surgical interventions and traumas, and also large bunch of the generically caused and acquired (secondary) thrombophilie. The contents of vitamin К1 in nutrition depend on a method of product preparation. The highest concentrations are found in dark green vegetables and grass: parsley, spinach, green turnip, and also in cabbage and lettuce.For achievement stable hypocoagulation at assignment of anticoagulants of indirect action the daily entering with nutrition of constant amounts of vitamin K (at a level 65-80 mkg/day) is necessary. Thus, a doctor at assignment of anticoagulants, is obliged to pay attention to character of a food and to inform patient about possible undesirable consequences at the use of products keeping high levels of vitamin К1.
Strain differences in toxicity of vitamin K antagonist warfarin in rats  [PDF]
?oki? Jelena,Ninkov Marina,Aleksandrov Popov Aleksandra,Mirkov Ivana
Journal of the Serbian Chemical Society , 2013, DOI: 10.2298/jsc121114010d
Abstract: Warfarin (4-hydroxy coumarin) is Vitamin K (VK) antagonist that inhibits Vitamin K-dependent (VKD) processes, such as blood coagulation. It exerts influence on some non-VKD-related activities as well. In this study, the effect of subacute (30-day) oral warfarin (2 mg L-1 and 1 mg L-1) intake on hematological parameters was examined in two rat strains, Albino Oxford (AO) and Dark Agouti (DA), that differ in their sensitivity to certain chemicals. Greater susceptibility to anticoagulant effect of 2 mg L-1 of warfarin was observed in AO rats and was associated with an increase in relevant hematological parameters in this strain. Although both strains responded to 2 mg L-1 of warfarin with quantitative changes in peripheral blood leukocytes differential bone marrow and lung responses were observed. Strain-related differences in proinflammatory activity of peripheral blood granulocytes and in mononuclear cell IFN-γ production were observed. Recognition of differences in quantitative and qualitative effects of oral warfarin on processes other than hemostasis might be of relevance for those humans who are on warfarin therapy. [Projekat Ministarstva nauke Republike Srbije, br. 173039]
New Oral Anticoagulants in the Treatment of Pulmonary Embolism: Efficacy, Bleeding Risk, and Monitoring  [PDF]
Kelly M. Rudd,Elizabeth (Lisa) M. Phillips
Thrombosis , 2013, DOI: 10.1155/2013/973710
Abstract: Anticoagulation therapy is mandatory in patients with pulmonary embolism to prevent significant morbidity and mortality. The mainstay of therapy has been vitamin-K antagonist therapy bridged with parenteral anticoagulants. The recent approval of new oral anticoagulants (NOACs: apixaban, dabigatran, and rivaroxaban) has generated significant interest in their role in managing venous thromboembolism, especially pulmonary embolism due to their improved pharmacokinetic and pharmacodynamic profiles, predictable anticoagulant response, and lack of required efficacy monitoring. This paper addresses the available literature, on-going clinical trials, highlights critical points, and discusses potential advantages and disadvantages of the new oral anticoagulants in patients with pulmonary embolism. 1. Introduction Pulmonary embolism (PE) is a common, potentially fatal disease with an annual incidence of approximately 70 cases per 100?000 people [1, 2]. Patients generally require hospitalization and recurrence is common [3]. In addition to significant morbidity and mortality, treatment costs associated with thrombosis and the arising postthrombotic syndromes are staggering, with costs exceeding 500 million dollars annually in the United States [1, 4, 5]. The mainstay of treatment for the past fifty years has been warfarin therapy, overlapped with a parenteral anticoagulant until the vitamin K antagonist (VKA) is fully therapeutic [2, 5]. While highly effective at reducing morbidity and mortality associated with PE, VKA therapy poses challenges, including variability in drug response, patient compliance, and drug-drug, drug-disease, and drug-diet interactions [6–9]. Great interest has been generated regarding the recently marketed new oral anticoagulants (NOACs) and their potential role as alternative anticoagulant therapies. 2. Risk Assessment in Pulmonary Embolism Pulmonary embolism is a serious and potentially fatal complication of a venous thrombotic event (VTE). Despite clinical trials yielding similar estimates for safety and efficacy in overall treatment when comparing deep vein thrombosis (DVT) and PE, patients with PE incur additional risks not seen in patients with DVT alone. The impact of PE on mortality is striking, with significant increases in the risk of death at both 30 and 90 days after event [10]. In addition to increasing mortality, PE also has significant impact on morbidity. Cardiorespiratory impairment, including pulmonary hypertension, can result in chronic and irreversible health concerns. Additionally, recurrent episodes of either VTE or PE
Twice- or Once-Daily Dosing of Novel Oral Anticoagulants for Stroke Prevention: A Fixed-Effects Meta-Analysis with Predefined Heterogeneity Quality Criteria  [PDF]
Andreas Clemens, Herbert Noack, Martina Brueckmann, Gregory Y. H. Lip
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0099276
Abstract: Background A number of novel oral anticoagulants (direct thrombin inhibitors or factor Xa inhibitors) are in clinical use for various indications. The dosing regimens differ between twice-daily and once-daily dosing for the prevention of stroke in patients with atrial fibrillation. With the availability of the results from four phase 3 studies (>70,000 patients), we explored whether twice-daily or once-daily dosing provides better risk-benefit balance among novel oral anticoagulants. Methods We conducted a strict, stepwise, fixed-effects meta-analysis with predefined heterogeneity quality criteria to generate the most appropriate common estimates for twice-daily (BID) or once-daily (QD) dosing regimens. An indirect comparison of these dosing regimens with fixed-effects meta-analysis common estimates (where available), or individual compound results, was done respectively. Results Comparing indirectly BID vs QD dosing regimens resulted in hazard ratios (HR [95% confidence interval]) for stroke and systemic embolism of 0.75 (0.58–0.96) for dabigatran 150 mg BID, and 0.91 (0.73–1.13) for apixaban BID vs the QD dosing regimen. For ischemic stroke, the HR of BID vs QD was 0.85 (0.69–1.05). For intracranial hemorrhage, BID vs rivaroxaban QD was 0.57 (0.37–0.88) and, vs edoxaban QD, 0.81 (0.54–1.22). Due to heterogeneity, common estimates for major bleeding QD or BID were not justified, therefore indirect comparison of regimens were not possible. All non-vitamin K antagonist oral anticoagulants reduced all-cause mortality vs warfarin with a HR of 0.90 (0.86–0.96) without differences between regimen. Conclusions Based on the available phase 3 study evidence, the twice-daily dosing regimen of non-vitamin K antagonist oral anticoagulants appears to offer a more balanced risk-benefit profile with respect to stroke prevention and intracranial hemorrhage.
Protein induced by vitamin K absence or antagonist II-producing gastric cancer  [cached]
Yoshihisa Takahashi, Tohru Inoue, Toshio Fukusato
World Journal of Gastrointestinal Pathophysiology , 2010,
Abstract: Protein induced by vitamin K absence or antagonist II (PIVKA-II) is a putative specific marker of hepatocellular carcinoma (HCC), but it may also be produced by a small number of gastric cancers. To date, 16 cases of PIVKA-II-producing gastric cancer have been reported, 2 of which were reported by us and all of which were identified in Japan. There are no symptoms specific to PIVKA-II-producing gastric cancer, and the representative clinical symptoms are general fatigue, appetite loss, and upper abdominal pain. Serum alpha-fetoprotein (AFP) levels are also increased in almost all cases. Liver metastasis is observed in approximately 80% of cases and portal vein tumor thrombus is observed in approximately 20% of cases. Differential diagnosis between metastatic liver tumor and HCC is often difficult. Grossly, almost all cases appear as advanced gastric cancer. Histologically, a hepatoid pattern is observed in many cases, in addition to a moderately to poorly differentiated adenocarcinoma component. The production of PIVKA-II and AFP is usually confirmed using immunohistochemical staining. Treatment and prognosis largely depends on the existence of liver metastasis, and the prognosis of patients with liver metastasis is very poor. PIVKA-II may be produced during the hepatocellularmetaplasia of the tumor cells.
Novel oral anticoagulants for stroke prevention in atrial fibrillation: a focus on the older patient
Yates SW
International Journal of General Medicine , 2013, DOI: http://dx.doi.org/10.2147/IJGM.S39379
Abstract: vel oral anticoagulants for stroke prevention in atrial fibrillation: a focus on the older patient Review (18) Total Article Views Authors: Yates SW Published Date March 2013 Volume 2013:6 Pages 167 - 180 DOI: http://dx.doi.org/10.2147/IJGM.S39379 Received: 20 October 2012 Accepted: 03 December 2012 Published: 21 March 2013 Scott W Yates Center for Executive Medicine, Plano, TX, USA Abstract: Atrial fibrillation (AF) is a common arrhythmia that is associated with an increased risk of stroke, particularly in the elderly. Traditionally, a vitamin K antagonist such as warfarin is prescribed for stroke prevention. Warfarin is effective at lowering stroke risk but has several limitations due to food restrictions, drug interactions, and a narrow therapeutic window. Various novel oral anticoagulants (NOACs) are available or under development to provide alternative treatment options. This article reviews the efficacy and safety of three NOACs (dabigatran etexilate, rivaroxaban, and apixaban) in addition to warfarin and aspirin, for prevention of stroke in patients with AF, focusing on the elderly population. Results of clinical trials demonstrate that the efficacy of NOACs for stroke prevention in patients with AF is as good as or better than that of warfarin. The NOACs are also associated with an equivalent or lower risk of bleeding. Regardless of the medication chosen, older patients with AF must be treated cautiously due to an increased risk of stroke and bleeding, as well as potential challenges related to drug interactions and monitoring requirements. NOACs may be suitable alternatives to warfarin for stroke prevention in older patients due to several advantages, including a faster onset of action, few drug or food interactions, and no requirement for regular monitoring. However, dose adjustments may be required for certain patients, such as those with severe renal impairment or in the setting of drug interactions.
Use of anticoagulants in elderly patients: practical recommendations
Helia Robert-Ebadi, Grégoire Le Gal, Marc Righini
Clinical Interventions in Aging , 2009, DOI: http://dx.doi.org/10.2147/CIA.S4308
Abstract: e of anticoagulants in elderly patients: practical recommendations Review (7966) Total Article Views Authors: Helia Robert-Ebadi, Grégoire Le Gal, Marc Righini Published Date April 2009 Volume 2009:4 Pages 165 - 177 DOI: http://dx.doi.org/10.2147/CIA.S4308 Helia Robert-Ebadi, Grégoire Le Gal, Marc Righini Division of Angiology and Hemostasis (HRE, MR), Department of Internal Medicine, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland, and Department of Internal Medicine and Chest Diseases, EA 3878 (GETBO), Brest University Hospital, Brest, France (GLG) Abstract: Elderly people represent a patient population at high thromboembolic risk, but also at high hemorrhagic risk. There is a general tendency among physicians to underuse anticoagulants in the elderly, probably both because of underestimation of thromboembolic risk and overestimation of bleeding risk. The main indications for anticoagulation are venous thromboembolism (VTE) prophylaxis in medical and surgical settings, VTE treatment, atrial fibrillation (AF) and valvular heart disease. Available anticoagulants for VTE prophylaxis and initial treatment of VTE are low molecular weight heparins (LMWH), unfractionated heparin (UFH) or synthetic anti-factor Xa pentasaccharide fondaparinux. For long-term anticoagulation vitamin K antagonists (VKA) are the first choice and only available oral anticoagulants nowadays. Assessing the benefit-risk ratio of anticoagulation is one of the most challenging issues in the individual elderly patient, patients at highest hemorrhagic risk often being those who would have the greatest benefit from anticoagulants. Some specific considerations are of utmost importance when using anticoagulants in the elderly to maximize safety of these treatments, including decreased renal function, co-morbidities and risk of falls, altered pharmacodynamics of anticoagulants especially VKAs, association with antiplatelet agents, patient education. Newer anticoagulants that are currently under study could simplify the management and increase the safety of anticoagulation in the future.
Use of anticoagulants in elderly patients: practical recommendations
Helia Robert-Ebadi,Grégoire Le Gal,Marc Righini
Clinical Interventions in Aging , 2009,
Abstract: Helia Robert-Ebadi, Grégoire Le Gal, Marc RighiniDivision of Angiology and Hemostasis (HRE, MR), Department of Internal Medicine, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland, and Department of Internal Medicine and Chest Diseases, EA 3878 (GETBO), Brest University Hospital, Brest, France (GLG)Abstract: Elderly people represent a patient population at high thromboembolic risk, but also at high hemorrhagic risk. There is a general tendency among physicians to underuse anticoagulants in the elderly, probably both because of underestimation of thromboembolic risk and overestimation of bleeding risk. The main indications for anticoagulation are venous thromboembolism (VTE) prophylaxis in medical and surgical settings, VTE treatment, atrial fibrillation (AF) and valvular heart disease. Available anticoagulants for VTE prophylaxis and initial treatment of VTE are low molecular weight heparins (LMWH), unfractionated heparin (UFH) or synthetic anti-factor Xa pentasaccharide fondaparinux. For long-term anticoagulation vitamin K antagonists (VKA) are the first choice and only available oral anticoagulants nowadays. Assessing the benefit-risk ratio of anticoagulation is one of the most challenging issues in the individual elderly patient, patients at highest hemorrhagic risk often being those who would have the greatest benefit from anticoagulants. Some specific considerations are of utmost importance when using anticoagulants in the elderly to maximize safety of these treatments, including decreased renal function, co-morbidities and risk of falls, altered pharmacodynamics of anticoagulants especially VKAs, association with antiplatelet agents, patient education. Newer anticoagulants that are currently under study could simplify the management and increase the safety of anticoagulation in the future.Keywords: anticoagulation, elderly patients, venous thromboembolism, hemorrhagic risk, atrial fibrillation, thrombin inhibitors, factor Xa inhibitor
Use of Prothrombin Complex Concentrate for Vitamin K Antagonist Reversal before Surgical Treatment of Intracranial Hemorrhage
Yun Wong
Clinical Medicine Insights: Case Reports , 2012, DOI: 10.4137/CCRep.S6433
Abstract: Background: Oral anticoagulant therapy (OAT) is used to prevent/treat thromboembolism. Major bleeding is common in patients on OAT; eg, warfarin increases intracranial hemorrhage (ICH) risk. Case: A 71-year-old male on warfarin (to reduce stroke risk) presented at Accident and Emergency Minor Injuries Unit with headache after reportedly sounding 'drunk'. On triage, the patient appeared lucid and well. However, International Normalized Ratio (INR) was 4.1. Head computed tomography (CT) indicated a large right-sided subdural hematoma. Prothrombin complex concentrate (PCC; Beriplex P/N, CSL Behring) with vitamin K normalized the INR within minutes of administration. The patient underwent neurosurgery without complications, and was discharged after 5 days, with no residual neurological symptoms. Conclusions: ICH patients can present with no neurological signs. In OAT patients with headache, INR must be established; if $3.0, normalization of INR and head CT are essential. PCC is the best option to rapidly reverse anticoagulation and correct INR pre-surgery.
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