Rivaroxaban in patients with diabetes mellitus and atrial fibrillation
Authors:
Monika Péčová 1,2; Jakub Benko 3; Martin Jozef Péč 3; Tomáš Bolek 3; Juraj Sokol 1; Matej Samoš 3; Eva Hajtmanová 2; Ján Staško 1; Marián Mokáň 3
Authors‘ workplace:
Klinika hematológie a transfuziológie JLF UK a UNM, Martin
1; Onkologické centrum UNM, Martin
2; I. interná klinika JLF UK a UNM, Martin
3
Published in:
Forum Diab 2022; 11(2): 87-93
Category:
Overview
The prevalence of atrial fibrillation and diabetes mellitus is rising, and these disorders frequently occur simultaneously. Diabetes mellitus is an independent risk factor of ischemic stroke and systemic embolism in patients with atrial fibrillation. Moreover, patients with atrial fibrillation-associated stroke and concomitant diabetes mellitus seem to have worse outcome compared to non-diabetic patients. Intensive activation of coagulation, decreased fibrinolytic activity, changes in platelet and endothelial function, together with increased levels of tissue plasminogen activator and factor VIII activity might directly link diabetes mellitus with atrial fibrillation-associated stroke. Long-term anticoagulation is indicated in majority of patients with diabetes mellitus and atrial fibrillation to prevent adverse embolic events connected with atrial fibrillation. This article reviews up-to-date literature regarding the use of rivaroxaban in patients with diabetes mellitus and with atrial fibrillation.
Keywords:
atrial fibrillation – diabetes mellitus – rivaroxaban – direct oral anticoagulants
Sources
1. Go AS, Hylek EM, Phillips KA et al. Prevalence of diagnosed atrial fibrillation in adults: National implications for rhythm management and stroke prevention: The AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285(18): 2370–2375. Dostupné z DOI: <http://dx.doi.org/10.1001/jama.285.18.2370>.
2. [GBD 2016 Disease and Injury Incidence and Prevalence Collaborators]. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100): 1211–1259. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140–6736(17)32154–2>.
3. [GBD 2016 Causes of Death Collaborators]. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980–2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017; 390(10100): 1151–1210. Dostupné z DOI: <http://dx.doi.org/10.1016/S0140–6736(17)32152–9>.
4. Prídavková D, Samoš M, Bolek T et al. Type 2 Diabetes, Atrial Fibrillation, and Direct Oral Anticoagulation. J Diabetes Res 2019; 2019: 5158308. Dostupné z DOI: <http://dx.doi.org/10.1155/2019/5158308>.
5. Ostgren CJ, Merlo J, Rastam L et al. [Skaraborg Hypertension and Diabetes Project]. Atrial fibrillation and its association with type 2 diabetes and hypertension in a Swedish community. Diabetes Obes Metab 2004; 6(5): 367–374. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1462–8902.2004.00358.x>.
6. Nichols GA, Reinier K, Chugh SS. Independent contribution of diabetes to increased prevalence and incidence of atrial fibrillation. Diabetes Care 2009; 32(10): 1851–1856. Dostupné z DOI: <http://dx.doi.org/10.2337/dc09–0939>.
7. Huxley RR, Alonso A, Lopez L et al. Type 2 diabetes, glucose homeostasis and incident atrial fibrillation: the Atherosclerosis Risk in Communities study. Heart 2012; 98(2): 133–138. Dostupné z DOI: <http://dx.doi.org/10.1136/heartjnl-2011–300503>.
8. Huxley RR, Filion KB, Konety S et al. Meta- analysis of cohort and case-control studies of type 2 diabetes mellitus and risk of atrial fibrillation. Am J Cardiol 2011; 108(1): 56–62. Dostupné z DOI: <http://dx.doi.org/10.1016/j.amjcard.2011.03.00>.
9. Tadic M, Cuspidi C. Type 2 diabetes mellitus and atrial fibrillation: from mechanisms to clinical practice. Arch Cardiovasc Dis 2015; 108(4): 269–276. Dostupné z DOI: <http://dx.doi.org/10.1016/j.acvd.2015.01.009>.
10. Hankey GJ, Jamrozik K, Broadhurst RJ et al. Long-term disability after first-ever stroke and related prognostic factors in the Perth Community Stroke Study, 1989–1990. Stroke 2002; 33(4): 1034–1040. Dostupné z DOI: <http://dx.doi.org/10.1161/01.str.0000012515.66889.2>.
11. Klem I, Wehinger C, Schneider B et al. Diabetic atrial fibrillation patients: mortality and risk for stroke or embolism during a 10-year follow-up. Diabetes Metab Res Rev 2003; 19(4): 320–328. Dostupné z DOI: <http://dx.doi.org/10.1002/dmrr.38>.
12. Muñoz-Rivas N, Méndez-Bailón M, Hernández-Barrera V et al. Time trends in ischemic stroke among type 2 diabetic and non-diabetic patients: analysis of the Spanish National Hospital Discharge Data (2003–2012). PLoS One 2015; 10(12): e0145535. Dostupné z DOI: <http://dx.doi.org/10.1371/journal.pone.0145535>.
13. Bell DS, Goncalves E. Atrial fibrillation and type 2 diabetes: Prevalence, etiology, pathophysiology and effect of an-ti-diabetic therapies. Diabetes Obes Metab 2019; 21(2): 210–217. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.13512>.
14. Lee S, Ay C, Kopp CW et al. Impaired glucose metabolism is associated with increased thrombin generation potential in patients undergoing angioplasty and stenting. Cardiovasc Diabetol 2018; 17(1): 131. Dostupné z DOI: <http://dx.doi.org/10.1186/s12933–018–0774–0>.
15. Benjamin EJ, Levy D, Vaziri SM et al. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA 1994; 271(11): 840–844. 16. Aksnes TA Schmieder RE, Kjeldsen SE et al. Impact of new-onset diabetes mellitus on develop- ment of atrial fibrillation and heart failure in high-risk hypertension (from the VALUE Trial). Am J Cardiol 2008; 101(5): 634–638. Dostupné z DOI: <http://dx.doi.org/10.1016/j.amjcard.2007.10.025>.
17. Murphy NF, Simpson C, Jhund P et. A national survey of the prevalence, incidence, primary care burden and treatment of atrial fibrillation in Scotland. Heart 2007; 93(5): 606–612. Dostupné z DOI: <http://dx.doi.org/10.1136/hrt.2006.107573>.
18. Chung MK, Eckhardt LL, Chen L.Y et al. Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation: A Scientific Statement from the American Heart Association. Circulation 2020; 141(16): e750–e772. Dostupné z DOI: <http://dx.doi.org/10.1161/CIR.0000000000000748>.
19. Connolly SJ Ezekowitz MD, Yusuf S et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361(12): 1139–1151. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa0905561>.
20. Giugliano RP, Ruff CT, Braunwald E et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2013; 369(22): 2093–2104. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1310907>.
21. Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365(11): 981–992. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1107039>.
22. Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365(10): 883–891. Dostupné z DOI: <http://dx.doi.org/10.1056/NEJMoa1009638>.
23. Turpie AG. New oral anticoagulants in atrial fibrillation. Eur Heart J 2008; 29(2): 155–165. Dostupné z DOI: <http://dx.doi.org/10.1093/eurheartj/ehm575>.
24. Abdulsattar Y, Bhambri R, Nogid A. Rivaroxaban (Xarelto) for the prevention of thromboembolic disease: an inside look at the oral direct factor Xa inhibitor. P T. 2009; 34(5):238–244. 25. Kubitza D, Becka M, Wensing G et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59–7939–an oral, direct Factor Xa inhibitor – after multiple dosing in healthy male subjects. Eur J Clin Pharmacol 2005; 61(12): 873–880. Dostupné z DOI: <http://dx.doi.org/10.1007/ s00228–005–0043–5>.
26. Gulseth MP, Michaud J, Nutescu EA. Rivaroxaban: an oral direct inhibitor of factor Xa. Am J Health System Pharm 2008; 65(16): 1520– 1529. Dostupné z DOI: <http://dx.doi.org/10.2146/ajhp070624>.
27. Kubitza D, Becka M, Voith B et al. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59–7939, an oral, direct factor Xa inhibitor. Clin Pharmacol Ther 2005; 78(4): 412–421. Dostupné z DOI: <http://dx.doi.org/10.1016/j.clpt.2005.06.011>.
28. Mueck W, Borris LC, Dahl OE et al. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost 2008; 100(3): 453–461. 29. Mueck W, Stampfuss J, Kubitza D et al. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin Pharmacokinet 2014; 53(1): 1–16. Dostupné z DOI: <http://dx.doi.org/10.1007/s40262–013–0100–7>.
30. Abrams PJ, Emerson CR. Rivaroxaban: a novel, oral, direct factor Xa inhibitor. Pharmacotherapy 2009; 29(2): 167–181. Dostupné z DOI: <http://dx.doi.org/10.1592/phco.29.2.167>.
31. Samoš M, Bolek T, Prídavková et al. Dlhodobá antikoagulačná liečba u pacientov s diabetes mellitus a fibriláciou predsiení – možnosti a úskalia. Forum Diab 2021; 10(2): 80–86.
32. Kubitza D, Becka M, Mueck W et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol 2010; 70(5): 703–712. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1365–2125.2010.03753.x>.
33. Yao X, Shah ND, Sangaralingham LR et al. Non-vitamin K antagonist oral anticoagulant dosing in patients with atrial fibrillation and renal dysfunction. J Am Coll Cardiol 2017; 69(23): 2779–2790. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jacc.2017.03.600>.
34. Haas S, Bode C, Norrving B et al. Practical guidance for using rivaroxaban in patients with atrial fibrillation: balancing benefit and risk. Vasc Health Risk Manag 2014; 10: 101–114. Dostupné z DOI: <http://dx.doi.org/10.2147/VHRM.S55246>.
35. Zou R, Tao J, Shi W et al. Meta-analysis of safety and efficacy for direct oral anticoagulation treatment of non-valvular atrial fibrillation in relation to renal function. Thromb Res 2017; 160: 41–50. Dostupné z DOI: <http://dx.doi.org/10.1016/j.thromres.2017.10.013>.
36. Yao X, Tangri N, Gersh BJ et al. Renal Outcomes in Anticoagulated Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017; 70(21): 2621–2632. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jacc.2017.09.1087>.
37. Zoni-Berisso M, Lercari F, Carazza T et al. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 2014; 6: 213–220. Dostupné z DOI: <http://dx.doi.org/10.2147/CLEP.S47385>.
38. Ng KH, Hart RG, Eikelboom JW. Anticoagulation in patients aged ≥75 years with atrial fibrillation: role of novel oral anticoagulants. Cardiol Ther 2013; 2(2): 135–149. Dostupné z DOI: <http://dx.doi.org/10.1007/s40119–013–0019-y>.
39. Samos M, Stanciakova L, Skornova I et al. Review of the Pharmacology of the Emerging Possibilities of the Direct Oral Anticoagulants Reversal. Curr Drug Metab 2017; 18(7): 643–650. Dostupné z DOI: <http://dx.doi.org/10.2174/1389200218666170413155351>.
40. Olesen JB, Fauchier L, Lane DA et al. Risk factors for stroke and thromboembolism in relation to age among patients with atrial fibrillation: the Loire Valley Atrial Fibrillation Project. Chest 2012; 141(1): 147–153. Dostupné z DOI: <http://dx.doi.org/10.1378/chest.11–0862>.
41. Davis TM, Millns H, Stratton IM et al. Risk factors for stroke in type 2 diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS) 29. Arch Intern Med 1999; 159(10): 1097–1103. Dostupné z DOI: <http://dx.doi.org/10.1001/archinte.159.10.1097>.
42. Varughese GI, Patel JV, Tomson J et al. The prothrombotic risk of diabetes mellitus in atrial fibrillation and heart failure. J Thromb Haemost 2005; 3(12): 2811–2813. Dostupné z DOI: <http://dx.doi.org/10.1111/j.1538–7836.2005.01694.x>.
43. Bansilal S, Bloomgarden Z, Halperin JL et al. Efficacy and safety of rivaroxaban in patients with diabetes and non-valvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J 2015; 170(4): 675–682.e8. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ahj.2015.07.006>.
44. Kurra S, Fink DA, Siris ES. Osteoporosis-associated fracture and diabetes. Endocrinol Metab Clin N Am 2014; 43(1): 233–243. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ecl.2013.09.004>.
45. Yamauchi M, Yamaguchi T, Nawata K et al. Relationships between undercarboxylated osteocalcin and vitamin K intakes, bone turnover, and bone mineral density in healthy women. Clin Nutr 2010; 29(6): 761–765. Dostupné z DOI: <http://dx.doi.org/10.1016/j.clnu.2010.02.010>.
46. Binding C, Olesen JB, Abrahamsen B et al. Osteoporotic fractures in patients with atrial fibrillation treated with conventional versus direct anticoagulants. J Am Coll Cardiol 2019; 74(17): 2150–2158. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jacc.2019.08.1025>.
47. Gu ZC, Zhou LY, Shen L et al. Non-vitamin K antagonist oral anticoagulants vs. warfarin at risk of fractures: a systematic review and meta-analysis of randomized controlled trials. Front Pharmacol 2018; 9: 348. Dostupné z DOI: <http://dx.doi.org/10.3389/fphar.2018.00348>.
48. Wijnen JC, van de Riet IR, Lijfering WM et al. Metformin use decreases the anticoagulant effect of phenprocoumon. J Thromb Haemost 2014; 12(6): 887–890. Dostupné z DOI: <http://dx.doi.org/10.1111/jth.12578>.
49. Gelosa P, Castiglioni L, Tenconi M et al. Pharmacokinetic drug interactions of the non-vitamin K antagonist oral anticoagulants (NOACs). Pharmacol Res 2018; 135: 60–79. Dostupné z DOI: <http://dx.doi.org/10.1016/j.phrs.2018.07.016>.
50. Namba S, Yamaoka-Tojo M, Kakizaki R et al. Effects on bone metabolism markers and arterial stiffness by switching to rivaroxaban from warfarin in patients with atrial fibrillation. Heart Vessels 2017; 32(8): 977–982. Dostupné z DOI: <http://dx.doi.org/10.1007/s00380–017–0950–2>.
51. Bansilal S, Bloomgarden Z, Halperin L et al. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J 2015; 170(4): 675–682.e8. Dostupné z DOI: <http://dx.doi.org/10.1016/j.ahj.2015.07.006>.
52. Cope S, Clemens A, Hammès F et al. Critical appraisal of network meta-analyses evaluating the efficacy and safety of new oral anticoagulants in atrial fibrillation stroke prevention trials. Value Health 2015; 18(2): 234–249. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jval.2014.10.012>.
53. Peacock WF, Tamayo S, Sicignano N et al. Comparison of the Incidence of Major Bleeding With Rivaroxaban Use Among Nonvalvular Atrial Fibrillation Patients With Versus Without Diabetes Mellitus. Am J Cardiol 2017; 119(5): 753–759. Dostupné z DOI: <http://dx.doi.org/10.1016/j.amjcard.2016.11.023>.
54. Coleman CI, Bunz TJ, Eriksson D et al. Effectiveness and safety of rivaroxaban vs warfarin in people with non-valvular atrial fibrillation and diabetes: an administrative claims database analysis. Diabet Med 2018; 35(8): 1105–1110. Dostupné z DOI: <http://dx.doi.org/10.1111/dme.13648>.
55. Hsu CC, Hsu PF, Sung SH et al. Is There a Preferred Stroke Prevention Strategy for Diabetic Patients with Non-Valvular Atrial Fibrillation? Comparing Warfarin, Dabigatran and Rivaroxaban. Thromb Haemost 2018; 118(1): 72–81. Dostupné z DOI: <http://dx.doi.org/10.1160/TH17–02–0095>.
56. Samoš M, Bolek T, Stančiaková L et al. Does type 2 diabetes affect the on-treatment levels of direct oral anticoagulants in patients with atrial fibrillation?. Diabetes Res Clin Pract 2018; 135: 172–177. Dostupné z DOI: <http://dx.doi.org/10.1016/j.diabres.2017.11.024>.
57. Baker WL, Beyer-Westendorf J, Bunz TJ et al. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab 2019; 21(9): 2107–2114. Dostupné z DOI: <http://dx.doi.org/10.1111/dom.13787>.
58. Hernandez AV, Bradley G, Khan M et al. Rivaroxaban vs warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes 2020; 6(4): 301–307. Dostupné z DOI: <http://dx.doi.org/10.1093/ehjqcco/qcz047>.
59. Lip GYH, Keshishian AV, Kang AL et al. Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus. Mayo Clin Proc 2020; 95(5): 929–943. Dostupné z DOI: <http://dx.doi.org/10.1016/j.mayocp.2019.05.032>.
60. Coleman CI, Costa OS, Brescia CW et al. Thromboembolism, bleeding and vascular death in nonvalvular atrial fibrillation patients with type 2 diabetes receiving rivaroxaban or warfarin. Cardiovasc Diabetol 2021; 20(1): 52. Dostupné z DOI: <http://dx.doi.org/10.1186/s12933–021–01250–5>.
61. Weir MR, Chen YW, He J et al. Effectiveness and safety of rivaroxaban versus warfarin among nonvalvular atrial fibrillation patients with obesity and diabetes. J Diabetes Complications 2021; 35(11): 108029. Dostupné z DOI: <http://dx.doi.org/10.1016/j.jdiacomp.2021.108029>.
62. Hua Y, Sun JY, Su Y et al. The Safety and Efficacy of Rivaroxaban Compared with Warfarin in Patients with Atrial Fibrillation and Diabetes: A Systematic Review and Meta-analysis. Am J Cardiovasc Drugs 2021; 21(1): 51–61. Dostupné z DOI: <http://dx.doi.org/10.1007/s40256–020–00407-z>.
63. Costa OS, O'Donnell B, Vardar B et al. Kidney, limb and ophthalmic complications, and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis. Curr Med Res Opin 2021; 37(9): 1493–1500. Dostupné z DOI: <http://dx.doi.org/10.1080/03007995.2021.1947217>.
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2022 Issue 2
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