Indicaciones de rivaroxabán en diferentes situaciones clínicas

Article information

Resumen

Rivaroxabán es un inhibidor oral directo y altamente selectivo del factor Xa de la coagulación. Los principales resultados del ROCKET-AF mostraron que en pacientes de alto riesgo con fibrilación auricular no valvular, rivaroxabán fue no inferior a la warfarina en la prevención del ictus o embolia sistémica, pero con un menor riesgo de intracraneales, fatales y en órgano crítico. Rivaroxabán ha demostrado ser eficaz y seguro en pacientes con insuficiencia renal, en pacientes ancianos, así como en aquellos con cardiopatía isquémica o ictus previo.

Rivaroxabán se toma una sola vez al día. En comparación con los otros nuevos anticoagulantes orales (ACO), rivaroxabán puede proporcionar un mejor cumplimiento y adherencia al tratamiento y, en consecuencia, reducir el riesgo de ictus durante el seguimiento. Además, las interacciones con otros fármacos son escasas. Esto, junto con que es de una sola toma diaria, hace que rivaroxabán suponga una excelente alternativa para la prevención de los episodios tromboembólicos en los pacientes polimedicados con fibrilación auricular.

En este manuscrito se revisa la evidencia disponible acerca de la eficacia y seguridad de rivaroxabán en los pacientes con fibrilación auricular en diferentes escenarios clínicos.

Palabras clave:

Rivaroxabán

Fibrilación auricular

Insuficiencia renal

Cardiopatía isquémica

Ictus

Una vez al día

Adherencia al tratamiento

Ancianos

Abstract

Rivaroxaban is an oral highly selective direct factor Xa inhibitor. The main results of ROCKET-AF showed that in high risk patients with nonvalvular atrial fibrillation, rivaroxabán was noninferior to warfarin for the prevention of stroke or systemic embolism, but with lesser risk of intracranial and fatal bleeding. Remarkably, rivaroxaban has been proven to be effective and safe in patients with renal dysfunction, elderly patients as well as in those with ischemic heart disease or previous stroke.

Rivaroxaban is taken only once daily. Compared with other new oral anticoagulants, this may provide better compliance and medication adherence and, consequently, a reduction in the risk of stroke during the follow-up. Moreover, the interactions with other drugs are low. This together with the once daily dose makes rivaroxabán an excellent alternative for the prevention of thromboembolic events in polymedicated patients with atrial fibrillation.

This manuscript reviews the available evidence about the efficacy and safety of rivaroxabán in patients with atrial fibrillation in different clinical settings.

Keywords:

Rivaroxabán

Atrial fibrillation

Renal insufficiency

Ischemic heart disease

Stroke

Once-daily

Medication adherence

Elderly

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Bibliografía

[1.]

R.G. Hart, L.A. Pearce, M.I. Aguilar.

Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation.

Ann Intern Med, 146 (2007), pp. 857-867

Medline

[2.]

C. Escobar, V. Barrios, D. Jiménez.

Atrial fibrillation and dabigatran: has the time come to use new anticoagulants?.

Cardiovasc Ther, 28 (2010), pp. 295-301

http://dx.doi.org/10.1111/j.1755-5922.2010.00216.x | Medline

[3.]

J. Hirsh, M. O’Donnell, J.I. Weitz.

New Anticoagulants.

Blood, 105 (2005), pp. 453-463

http://dx.doi.org/10.1182/blood-2003-12-4195 | Medline

[4.]

V. Barrios, A. Calderón, C. Escobar, M. De la Figuera.

Pacientes con fibrilación auricular asistidos en consultas de atención primaria Estudio Val-FAAP.

Rev Esp Cardiol, 65 (2012), pp. 47-53

http://dx.doi.org/10.1016/j.recesp.2011.08.008 | Medline

[5.]

D.J. Pinto, J.X. Qiao, R.M. Knabb.

The emergence of factor Xa inhibitors for the treatment of cardiovascular diseases: a patent review.

Expert Opin Ther Pat, 22 (2012), pp. 645-661

http://dx.doi.org/10.1517/13543776.2012.680438 | Medline

[6.]

European Medicines Agency (EMA). Xarelto®, “Summary of Product Characteristics”. Updated 20-Janurary-2012. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf

[7.]

V. Barrios, C. Escobar.

Rivaroxaban: a once-daily anticoagulant for the prevention of thromboembolic complications Expert Rev Cardiovasc Ther.

En prensa, (2012),

[8.]

R. Kreutz.

Pharmacodynamic and pharmacokinetic basics of rivaroxabán.

Fundam. Clin Pharmacol, 26 (2012), pp. 27-32

http://dx.doi.org/10.1111/j.1472-8206.2011.00981.x | Medline

[9.]

M.R. Patel, K.W. Mahaffey, J. Garg, G. Pan, D.E. Singer, W. Hacke, ROCKET AF Investigators, et al.

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

N Engl J Med, 365 (2011), pp. 883-891

http://dx.doi.org/10.1056/NEJMoa1009638 | Medline

[10.]

ROCKET AF Study Investigators.

Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF Study.

Am Heart J, 159 (2010), pp. 340-347

http://dx.doi.org/10.1016/j.ahj.2009.11.025 | Medline

[11.]

V. Barrios, C. Escobar, N. Murga, C. De Pablo, V. Bertomeu, A. Calderón, et al.

Clinical profile and management of hypertensive patients with chronic ischemic heart disease and renal dysfunction attended by cardiologists in daily clinical practice.

J Hypertens, 26 (2008), pp. 2230-2235

http://dx.doi.org/10.1097/HJH.0b013e328311cdee | Medline

[12.]

R.G. Hart, J.W. Eikelboom, A.J. Ingram, C.A. Herzog.

Anticoagulants in atrial fibrillation patients with chronic kidney disease.

Nat Rev Nephrol, 8 (2012), pp. 569-578

http://dx.doi.org/10.1038/nrneph.2012.160 | Medline

[13.]

K.A. Fox, J.P. Piccini, D. Wojdyla, R.C. Becker, J.L. Halperin, C.C. Nessel, et al.

Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment.

Eur Heart J, 32 (2011), pp. 2387-2394

http://dx.doi.org/10.1093/eurheartj/ehr342 | Medline

[14.]

G.J. Hankey, M.R. Patel, S.R. Stevens, R.C. Becker, G. Breithardt, A. Carolei, ROCKET AF Steering Committee Investigators, et al.

Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF.

Lancet Neurol, 11 (2012), pp. 315-322

http://dx.doi.org/10.1016/S1474-4422(12)70042-X | Medline

[15.]

V. Barrios, C. Escobar, V. Bertomeu, N. Murga, C. De Pablo, A. Calderón.

Control de los factores de riesgo en los pacientes hipertensos con cardiopatía isquémica crónica atendidos en las consultas de cardiología Estudio CINHTIA.

Rev Clin Esp, 208 (2008), pp. 400-404

Medline

[16.]

V. Barrios, C. Escobar, R. Echarri.

Atrial fibrillation and coronary heart disease: fatal attraction.

J Atr Fibrillation, 1 (2009), pp. 262-269

[17.]

A.J. Camm, G.Y. Lip, R. De Caterina, I. Savelieva, D. Atar, S.H. Hohnloser, et al.

2012 focused update of the ESC Guidelines for the management of atrial fibrillation: An update of the 2010 ESC Guidelines for the management of atrial fibrillation * Developed with the special contribution of the European Heart Rhythm Association.

Eur Heart J, 33 (2012), pp. 2719-2747

http://dx.doi.org/10.1093/eurheartj/ehs253 | Medline

[18.]

A.C. Skanes, J.S. Healey, J.A. Cairns, P. Dorian, A.M. Gillis, M.S. McMurtry, Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee, et al.

Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control.

Can J Cardiol, 28 (2012), pp. 125-136

http://dx.doi.org/10.1016/j.cjca.2012.01.021 | Medline

[19.]

G. Agnelli, A. Gallus, S.Z. Goldhaber, S. Haas, M.V. Huisman, R.D. Hull, et al.

Treatment of proximal deep-vein thrombosis with the oral direct factor Xa inhibitor rivaroxaban (BAY 59–7939): the ODIXa-DVT (Oral Direct Factor Xa Inhibitor BAY 59–7939 in Patients With Acute Symptomatic Deep-Vein Thrombosis) study.

Circulation, 116 (2007), pp. 180-187

http://dx.doi.org/10.1161/CIRCULATIONAHA.106.668020 | Medline

[20.]

H.R. Buller, LensingAW, M.H. Prins, G. Agnelli, A. Cohen, A.S. Gallus, et al.

A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study.

Blood, 112 (2008), pp. 2242-2247

http://dx.doi.org/10.1182/blood-2008-05-160143 | Medline

[21.]

C.M. Dezii.

A retrospective study of persistence with single-pill combination therapy vs. concurrent two-pill therapy in patients with hypertension.

Manag Care, 9 (2000), pp. 2-6

Medline

[22.]

W.H. Frishman.

Importance of medication adherence in cardiovascular disease and the value of once-daily treatment regimens.

Cardiol Rev, 15 (2007), pp. 257-263

http://dx.doi.org/10.1097/CRD.0b013e3180cabbe7 | Medline