Rivaroxaban
Rivaroxaban
Klass: A
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Produkter
Xarelto
XareltoATC-koder
B01AF01
B01AF01Substanser
rivaroxaban
rivaroxabanSammanfattning
Kliniska studier visar att rivaroxaban reducerar risken för stroke och systemisk embolism lika effektivt hos kvinnor och män med förmaksflimmer. Effekten av rivaroxaban som initial behandling och som recidivprofylax av djup ventrombos och lungemboli är lika hos kvinnor och män.
En lägre blödningsrisk har setts hos kvinnor men inte hos män som behandlats med rivaroxaban vid förmaksflimmer. För patienter som behandlats med rivaroxaban för djup ventrombos eller lungemboli har inga könsskillnader setts i kliniska studier.
Background
Pharmacokinetics and dosing
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A single-blind, placebo-controlled study in healthy individuals (16 men, 16 women) found no effect of sex on the pharmacokinetics and pharmacodynamics of rivaroxaban 10 mg [12]. No studies with a clinically relevant sex analysis regarding the dosing of rivaroxaban have been found.
Effect
New oral anticoagulants
In atrial fibrillation (AF) patients, large meta-analyses of phase III trials have found that NOACs (apixaban, dabigatran, edoxaban, rivaroxaban) are better than warfarin in preventing stroke and systemic embolism in both men and women [1-3]. In contrast, a meta-analysis on data from other phase III trials (in total 18 415 men, 13 094 women) on NOACs (apixaban, dabigatran, ximelagatran), found that men were more protected from stroke or systemic embolism than women [4]. An observational study on AF patients in Hong-Kong (4972 men, 4834 women) showed that use of NOACs (apixaban, dabigatran, rivaroxaban) was associated with lower all-cause mortality in women but not in men, when compared to warfarin [5]. However, risk of stroke and response t......
Försäljning på recept
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Fler män än kvinnor hämtade ut tabletter innehållande rivaroxaban (ATC-kod B01AF01) på recept i Sverige år 2017, totalt 26 507 män och 21 137 kvinnor. Det motsvarar 5,3 respektive 4,2 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var tabletter innehållande rivaroxaban 1,6 gånger vanligare hos män [18].
Referenser
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Ahmad Y, Lip GY, Apostolakis S. New oral anticoagulants for stroke prevention in atrial fibrillation: impact of gender, heart failure, diabetes mellitus and paroxysmal atrial fibrillation. Expert Rev Cardiovasc Ther. 2012;10(12):1471-80.
Pancholy SB, Sharma PS, Pancholy DS, Patel TM, Callans DJ, Marchlinski FE. Meta-analysis of gender differences in residual stroke risk and major bleeding in patients with nonvalvular atrial fibrillation treated with oral anticoagulants. Am J Cardiol. 2014;113(3):485-90.
Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62.
Proietti M, Cheli P, Basili S, Mazurek M, Lip GY. Balancing thromboembolic and bleeding risk with non-vitamin K antagonist oral anticoagulants (NOACs): A systematic review and meta-analysis on gender differences. Pharmacol Res. 2017;117(1):274-282.
Law SWY, Lau WCY, Wong ICK, Lip GYH, Mok MT, Siu CW et al. Sex-Based Differences in Outcomes of Oral Anticoagulation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2018;72(3):271-282.
Raccah BH, Perlman A, Zwas DR, Hochberg-Klein S, Masarwa R, Muszkat M et al. Gender Differences in Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation: Systematic Review and Network Meta-analysis. Ann Pharmacother. 2018;52(11):1135-1142.
Alotaibi GS, Almodaimegh H, McMurtry MS, Wu C. Do women bleed more than men when prescribed novel oral anticoagulants for venous thromboembolism? A sex-based meta-analysis. Thromb Res. 2013;132(2):185-9.
Loffredo L, Violi F, Perri L. Sex related differences in patients with acute venous thromboembolism treated with new oral anticoagulants A meta-analysis of the interventional trials. Int J Cardiol. 2016;212:255-8.
Lapner S, Cohen N, Kearon C. Influence of sex on risk of bleeding in anticoagulated patients: a systematic review and meta-analysis. J Thromb Haemost. 2014;12(5):595-605.
Gómez-Outes A, Terleira-Fernández AI, Lecumberri R, Suárez-Gea ML, Vargas-Castrillón E. Direct oral anticoagulants in the treatment of acute venous thromboembolism: a systematic review and meta-analysis. Thromb Res. 2014;134:774-82.
Hokusai-VTE Investigators, Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369:1406-15.
Kubitza D, Becka M, Zuehlsdorf M, Mueck W. Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects. J Clin Pharmacol. 2007;47:218-26.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-91.
Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL et al. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016;5(3):e002197.
EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-510.
EINSTEIN–PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-97.
Krause M, Henningsen A, Torge A, Juhl D, Junker R, Kenet G et al. Impact of gender on safety and efficacy of Rivaroxaban in adolescents & young adults with venous thromboembolism. Thromb Res. 2016;148(1):145-151.
Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2019-01-30.]
- Ahmad Y, Lip GY, Apostolakis S. New oral anticoagulants for stroke prevention in atrial fibrillation: impact of gender, heart failure, diabetes mellitus and paroxysmal atrial fibrillation. Expert Rev Cardiovasc Ther. 2012;10(12):1471-80.
- Pancholy SB, Sharma PS, Pancholy DS, Patel TM, Callans DJ, Marchlinski FE. Meta-analysis of gender differences in residual stroke risk and major bleeding in patients with nonvalvular atrial fibrillation treated with oral anticoagulants. Am J Cardiol. 2014;113(3):485-90.
- Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955-62.
- Proietti M, Cheli P, Basili S, Mazurek M, Lip GY. Balancing thromboembolic and bleeding risk with non-vitamin K antagonist oral anticoagulants (NOACs): A systematic review and meta-analysis on gender differences. Pharmacol Res. 2017;117(1):274-282.
- Law SWY, Lau WCY, Wong ICK, Lip GYH, Mok MT, Siu CW et al. Sex-Based Differences in Outcomes of Oral Anticoagulation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2018;72(3):271-282.
- Raccah BH, Perlman A, Zwas DR, Hochberg-Klein S, Masarwa R, Muszkat M et al. Gender Differences in Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation: Systematic Review and Network Meta-analysis. Ann Pharmacother. 2018;52(11):1135-1142.
- Alotaibi GS, Almodaimegh H, McMurtry MS, Wu C. Do women bleed more than men when prescribed novel oral anticoagulants for venous thromboembolism? A sex-based meta-analysis. Thromb Res. 2013;132(2):185-9.
- Loffredo L, Violi F, Perri L. Sex related differences in patients with acute venous thromboembolism treated with new oral anticoagulants A meta-analysis of the interventional trials. Int J Cardiol. 2016;212:255-8.
- Lapner S, Cohen N, Kearon C. Influence of sex on risk of bleeding in anticoagulated patients: a systematic review and meta-analysis. J Thromb Haemost. 2014;12(5):595-605.
- Gómez-Outes A, Terleira-Fernández AI, Lecumberri R, Suárez-Gea ML, Vargas-Castrillón E. Direct oral anticoagulants in the treatment of acute venous thromboembolism: a systematic review and meta-analysis. Thromb Res. 2014;134:774-82.
- Hokusai-VTE Investigators, Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369:1406-15.
- Kubitza D, Becka M, Zuehlsdorf M, Mueck W. Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects. J Clin Pharmacol. 2007;47:218-26.
- Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-91.
- Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL et al. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016;5(3):e002197.
- EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-510.
- EINSTEIN–PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-97.
- Krause M, Henningsen A, Torge A, Juhl D, Junker R, Kenet G et al. Impact of gender on safety and efficacy of Rivaroxaban in adolescents & young adults with venous thromboembolism. Thromb Res. 2016;148(1):145-151.
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2019-01-30.]
Uppdaterat
Litteratursökningsdatum 1/22/2019
Litteratursökningsdatum 1/22/2019Se även
Warfarin
Apixaban
Dabigatran
Edoxaban