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1.
BMJ ; 379: e072623, 2022 11 23.
Artículo en Inglés | MEDLINE | ID: mdl-36520715

RESUMEN

OBJECTIVE: To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT). DESIGN: Randomised, double blind, placebo controlled clinical trial. SETTING: 28 outpatient clinics specialising in venous thromboembolism. PARTICIPANTS: 402 adults (≥18 years) with symptomatic isolated distal DVT. INTERVENTIONS: After receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion. MAIN OUTCOMES MEASURES: The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes. RESULTS: 200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred. CONCLUSIONS: Rivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage. TRIAL REGISTRATION: EudraCT 2016-000958-36; ClinicalTrials.gov NCT02722447.


Asunto(s)
Embolia Pulmonar , Tromboembolia Venosa , Trombosis de la Vena , Adulto , Humanos , Rivaroxabán/efectos adversos , Tromboembolia Venosa/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/inducido químicamente , Embolia Pulmonar/tratamiento farmacológico , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico
2.
PLoS One ; 14(7): e0219751, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31310608

RESUMEN

BACKGROUND: D-dimer levels measured during and after vitamin K antagonist withdrawal may be used in clinical practice to assess the individual risk of recurrent venous thromboembolism. Currently, direct oral anticoagulants (DOACs) are frequently used in venous thromboembolism treatment; however, their pharmacokinetics and pharmacodynamics characteristics are completely different than vitamin K antagonists. The present study aimed at comparing the results of D-dimer levels during and after anticoagulation withdrawal in patients with venous thromboembolism treated with DOACs or warfarin. MATERIAL AND METHODS: D-dimer levels were measured in 527 patients ("cases") during DOACs treatment (T0) and after 15 (T15), 30 (T30), 60 (T60) and 90 (T90) days after their discontinuation and in 527 patients ("controls") enrolled in the DULCIS study (all treated with warfarin), matched for sex, age (+/-3 y), type of D-dimer assay and site of venous thromboembolism. Both cases and controls received anticoagulant treatment after a first venous thromboembolism event that was unprovoked or associated with weak risk factors. RESULTS: The rate of positive D-dimer results was significantly higher in cases than in controls at T0 (10.8% vs 5.1%, p = 0.002) and at T30 (18.8% vs 11.8%, p = 0.019), as well as at the other time-points, though not statistically significant. CONCLUSION: D-dimer levels during and after stopping an anticoagulant treatment for a venous thromboembolism episode differ between patients treated with a DOAC than in those treated with warfarin. Specifically designed prospective studies are warranted to reassess the use of D-dimer as predictor of the risk of recurrent venous thromboembolism in patients treated with DOACs.


Asunto(s)
Anticoagulantes/uso terapéutico , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Tromboembolia Venosa/sangre , Tromboembolia Venosa/tratamiento farmacológico , Administración Oral , Anciano , Estudios de Casos y Controles , Técnicas de Laboratorio Clínico/normas , Ensayos Clínicos como Asunto , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Riesgo , Rivaroxabán/uso terapéutico , Vitamina K/antagonistas & inhibidores , Vitamina K/sangre , Warfarina/uso terapéutico
3.
Expert Opin Pharmacother ; 14(5): 655-67, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23414291

RESUMEN

INTRODUCTION: Until recently, only vitamin K antagonists (VKAs) were used for long-term anticoagulation. New oral anticoagulants, with pharmacokinetic and pharmacodynamic characteristics different to VKAs, are now available for some indications. Rivaroxaban (Xarelto®) is an oral Factor Xa inhibitor approved in many countries for long-term treatment of patients with atrial fibrillation or venous thromboembolism. This article is addressed to all professionals involved in the management of treated patients to highlight the characteristics of rivaroxaban and provide practical guidance on management of treated patients. AREAS COVERED: This article is based on a consensus of specialists involved in the management of anticoagulant treatment, including thrombosis experts, cardiologists, neurologists, emergency medicine specialists, and general practitioners. The authors performed a nonsystematic review of the literature, and expressed guidance statements based on the results of the review as well as personal experience. EXPERT OPINION: Availability of new anticoagulant drugs, including rivaroxaban, is an important step forward to allow easier, more effective, and safer long-term anticoagulation in patients in whom adequate anticoagulation is currently denied due to the limitations of VKAs. However, given their totally new properties, associated risks, and expected broad clinical use, expert professionals and manufacturers must urgently tackle a series of issues.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Morfolinas/uso terapéutico , Tiofenos/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Administración Oral , Animales , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Fibrilación Atrial/sangre , Coagulación Sanguínea/efectos de los fármacos , Consenso , Interacciones Farmacológicas , Sustitución de Medicamentos , Factor Xa/metabolismo , Inhibidores del Factor Xa , Hemorragia/inducido químicamente , Humanos , Cumplimiento de la Medicación , Morfolinas/administración & dosificación , Morfolinas/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Guías de Práctica Clínica como Asunto , Rivaroxabán , Tiofenos/administración & dosificación , Tiofenos/efectos adversos , Resultado del Tratamiento , Tromboembolia Venosa/sangre
4.
Chest ; 141(2 Suppl): e44S-e88S, 2012 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-22315269

RESUMEN

BACKGROUND: The objective of this article is to summarize the published literature concerning the pharmacokinetics and pharmacodynamics of oral anticoagulant drugs that are currently available for clinical use and other aspects related to their management. METHODS: We carried out a standard review of published articles focusing on the laboratory and clinical characteristics of the vitamin K antagonists; the direct thrombin inhibitor, dabigatran etexilate; and the direct factor Xa inhibitor, rivaroxaban RESULTS: The antithrombotic effect of each oral anticoagulant drug, the interactions, and the monitoring of anticoagulation intensity are described in detail and discussed without providing specific recommendations. Moreover, we describe and discuss the clinical applications and optimal dosages of oral anticoagulant therapies, practical issues related to their initiation and monitoring, adverse events such as bleeding and other potential side effects, and available strategies for reversal. CONCLUSIONS: There is a large amount of evidence on laboratory and clinical characteristics of vitamin K antagonists. A growing body of evidence is becoming available on the first new oral anticoagulant drugs available for clinical use, dabigatran and rivaroxaban.


Asunto(s)
Anticoagulantes/administración & dosificación , Medicina Basada en la Evidencia , Guías de Práctica Clínica como Asunto , Sociedades Médicas , Trombosis/tratamiento farmacológico , Trombosis/prevención & control , Administración Oral , Anticoagulantes/efectos adversos , Anticoagulantes/farmacocinética , Antitrombinas/administración & dosificación , Antitrombinas/efectos adversos , Antitrombinas/farmacocinética , Bencimidazoles/administración & dosificación , Bencimidazoles/efectos adversos , Bencimidazoles/farmacocinética , Dabigatrán , Relación Dosis-Respuesta a Droga , Factor Xa/metabolismo , Inhibidores del Factor Xa , Humanos , Morfolinas/administración & dosificación , Morfolinas/efectos adversos , Morfolinas/farmacocinética , Piridinas/administración & dosificación , Piridinas/efectos adversos , Piridinas/farmacocinética , Rivaroxabán , Tiofenos/administración & dosificación , Tiofenos/efectos adversos , Tiofenos/farmacocinética , Trombosis/sangre , Estados Unidos , Vitamina K/antagonistas & inhibidores , Vitamina K/sangre
5.
Eur J Haematol ; 84(6): 484-92, 2010 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-20192986

RESUMEN

BACKGROUND: Venous thromboembolism (VTE) is a major complication of myeloma therapy recently observed with the increasing use of up-front thalidomide and dexamethasone (thal-dex). The pathogenesis of thal-induced VTE is not well recognized, and the role of prothrombotic factors, especially of thrombophilic abnormalities, is not yet determined. MATERIAL AND METHODS: Two hundred and sixty-six patients with newly diagnosed multiple myeloma (MM) were primarily treated with thal-dex in preparation for subsequent high-dose therapy and autologous stem-cell transplantation. Out of these 266 patients, 190 were evaluated for thrombophilic alterations at baseline, and 125 of them were also re-assessed after thal-dex therapy. RESULTS: The presence of genetic thrombophilic polymorphisms among patients with MM was superimposable to that of normal controls and was associated with a twofold increase in the relative risk of VTE. aAPCR and elevated factor VIII levels were frequent, albeit transient, alterations and were not associated with a significant increase in the risk of VTE. Two hundred and forty-six patients received a thromboprophylaxis with fixed low-dose warfarin (1.25 mg/day) during thal-dex therapy. Of these patients (or 10.6%), 26 had symptomatic VTE events. Their patients-years rate of VTE (35.5%) was significantly lower in comparison with the 86.2% rate recorded among the first 19 patients who initially entered the study and did not receive any kind of thromboprophylaxis (P = 0.043). CONCLUSIONS: On the basis of these data, a baseline thrombophilic work up is not recommended in patients with receiving up-front thal-dex. For these patients, fixed low-dose warfarin may be a valuable prophylaxis against VTE.


Asunto(s)
Dexametasona/administración & dosificación , Mieloma Múltiple/tratamiento farmacológico , Talidomida/administración & dosificación , Trombofilia/inducido químicamente , Trombosis/inducido químicamente , Trombosis/prevención & control , Resistencia a la Proteína C Activada/genética , Adulto , Anciano , Anticoagulantes/administración & dosificación , Estudios de Casos y Controles , Dexametasona/efectos adversos , Factor V/genética , Factor VIII/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mieloma Múltiple/sangre , Protrombina/genética , Factores de Riesgo , Talidomida/efectos adversos , Trombofilia/sangre , Trombofilia/genética , Tromboembolia Venosa/inducido químicamente , Tromboembolia Venosa/prevención & control , Warfarina/administración & dosificación
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