Rivaroxaban (Xarelto) for stroke prevention in non-valvular atrial fibrillation (riv-ah-rocks-ah-ban)

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1 1 for stroke prevention in non-valvular atrial fibrillation (riv-ah-rocks-ah-ban) An oral anticoagulant for the prevention of stroke in people with non-valvular atrial fibrillation KEY POINTS Rivaroxaban is a direct factor Xa inhibitor oral anticoagulant Rivaroxaban taken once daily has demonstrated efficacy in stroke prevention in people with non-valvular atrial fibrillation (NVAF). Rivaroxaban was non-inferior to warfarin for stroke reduction in NVAF In clinical trials, rivaroxaban efficacy was superior to that of warfarin in the safety-ontreatment population but not the intention-to-treat population, and with a similar incidence of major bleeding. People well controlled by warfarin will probably not benefit from changing to rivaroxaban There is no clinical advantage in changing from warfarin for people who are well controlled (time in therapeutic range [INR ] 60%). However, people who are not well controlled on warfarin may benefit from rivaroxaban. Coagulation monitoring is not required; however, there is no antidote for rivaroxaban-induced bleeding Advise patients to seek urgent medical attention for unexplained bruising, blood in the urine, black stools or prolonged bleeding. Be cautious when switching between warfarin and rivaroxaban There is limited evidence on switching from or to other anticoagulants. Consult the product information. Rivaroxaban is contraindicated in people with NVAF with either significant hepatic disease with an increased INR, or severe renal impairment Do not use in people with hepatic disease (Child Pugh grade B or C) who also have coagulopathy-associated bleeding risk, or in people with severe renal impairment (creatinine clearance < 30 ml/min). ADDITIONAL INFORMATION Refer to this review at for more information about the Child Pugh classification of liver disease. PBS listing Authority required (Streamlined) The patient must have non-valvular atrial fibrillation and one or more of the following risk factors for developing stroke or systemic ischaemic embolism: prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism age 75 years or older hypertension diabetes mellitus heart failure and/or left ventricular ejection fraction 35% or less. 3 May be prescribed by nurse practitioners (shared care model) Authorised nurse practitioners may prescribe this medicine when care of a patient is shared between a nurse practitioner and medical practitioner in a formalised arrangement with an agreed management plan. See the PBS website for more information on nurse practitioner PBS prescribing. 3

2 2 EVIDENCE SNAPSHOT WHAT IS KNOWN ABOUT THIS DRUG? Rivaroxaban is an oral anticoagulant that inhibits factor Xa. Rivaroxaban 20 mg once daily (or 15 mg once daily in people with moderate renal impairment, [creatinine clearance ml/ min]) is non-inferior to warfarin in preventing stroke or systemic embolic events (1.7% vs 2.2% of events per year; hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.66 to 0.96, p < 0.001). 4 Rivaroxaban is non-inferior to warfarin with respect to any major bleeding (5.6% vs 5.4%; HR 1.04, 95% CI 0.90 to 1.20, p = 0.576). 4 There were significantly fewer intracranial haemorrhages with rivaroxaban (absolute risk reduction 0.2% per year) but gastrointestinal bleeding was significantly more common (absolute risk increase 1.0% per year). 4 AREAS OF UNCERTAINTY There have been no head-to-head studies of rivaroxaban with other newer oral anticoagulants. Safety data are currently limited to < 2 years follow up. 4 The benefits of rivaroxaban for people with low risk of stroke and those well controlled on warfarin have not been demonstrated. 4 There is no validated antidote available for rivaroxaban, and experience of switching between anticoagulants is limited. 4,5 There are no data regarding the use of rivaroxaban in people already known to be unsuitable for warfarin therapy. The safety of rivaroxaban has not been established in people at high risk of bleeding, as these people were excluded from the pivotal randomised clinical trial. 5 WHAT DOES NPS SAY? There is no evidence to show that people with an INR consistently in the therapeutic range ( ) will benefit clinically from a switch to rivaroxaban. Rivaroxaban is an alternative to consider for people at risk of stroke and who, for reasons other than poor compliance, cannot be suitably controlled on warfarin (i.e. unable to maintain INR consistently within the therapeutic range). People with a history of poor compliance may be unsuitable for rivaroxaban due to its short halflife, resulting in increased risk of stroke if doses are missed. In these circumstances, warfarin remains preferable, as it has a longer half-life and compliance can be monitored. Rivaroxaban may be an option for people: who are compliant with warfarin but who have difficulty maintaining INR in the therapeutic range who experience drug or major drug food interactions with warfarin with poor venous access for INR monitoring and for whom point-of-care testing is not possible for whom regular INR monitoring is impractical.

3 3 ADDITIONAL INFORMATION Refer to this review at for more information about the CHADS 2 schema for selecting antithrombotic therapy in non-valvular AF. What is it? Rivaroxaban is an oral direct factor Xa inhibitor that is taken once daily for stroke prevention in non-valvular atrial fibrillation (NVAF). Rivaroxaban has a short half-life (5 13 hours, depending on age) with peak concentration attained 2 4 hours after dosing. 2 Rivaroxaban has a dual mode of elimination one-third of the active drug is eliminated unchanged in the urine and two-thirds are metabolised by the liver. 3 Who is it for? Rivaroxaban is PBS listed for preventing stroke or systemic embolism in patients with NVAF and one or more risk factors for developing stroke or systemic embolism (see PBS Listing section, page 1). Rivaroxaban is also PBS listed for: prevention of venous thromboembolism after hip or knee replacement surgery [see the August 2009 NPS RADAR review for preventing venous thromboembolism after hip or knee replacement surgery] treatment of acute symptomatic deep vein thrombosis, acute symptomatic pulmonary embolism and for the prevention of venous thromboembolism recurrence in people with a history of venous thromboembolism [see the August 2013 NPS RADAR review for treatment of deep vein thrombosis and pulmonary embolism, and for prevention of venous thromboembolism recurrence ]. People with NVAF who are at increased risk of stroke, and in whom warfarin is otherwise contraindicated, may benefit from the use of an oral anticoagulant such as rivaroxaban. However, there are no data regarding the use of rivaroxaban in people already known to be unsuitable for warfarin therapy. While warfarin has been the mainstay therapy for stroke prevention in NVAF, several studies have indicated suboptimal usage, with many patients identified with low time in the therapeutic range (TTR). 6 8 Determine the need for anticoagulation Guidelines recommend the CHADS 2 (or the CHA 2 DS 2 -VASc) thromboembolic risk scoring system to assist in the decision whether to initiate an oral anticoagulant. 9 The CHADS 2 score rates risk from 0 to 6, with 1 indicating the requirement for an oral anticoagulant. The more predictive CHA 2 DS 2 -VASc score ranges from 0 to 9, with a score of 2 for females < 65 years or 1 for males regarded as an indication for long-term oral anticoagulation. 10 The requirement for anticoagulation should always be balanced against risk of bleeding. A recently derived scoring schema for predicting the bleeding risk in people with NVAF (HAS-BLED, [hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly]) may also be a useful assessment tool. 11,12 The current Australian Therapeutic Guidelines recommends either warfarin or dabigatran for people with NVAF and at least one other risk factor for stroke. 9 The Australian Medicines Handbook states that warfarin, dabigatran or rivaroxaban can be used for people with NVAF and at least one other risk factor for stroke. 13 International guidelines such as the Canadian Agency for Drugs and Technologies in Health, the National Institute for Health and Clinical Excellence (UK) and the American College of Chest Physicians also provide recommendations for use of the various newer anticoagulants Review current anticoagulant control when considering rivaroxaban for people with NVAF Rivaroxaban is an option alongside warfarin, dabigatran or apixaban for people with NVAF and at risk of stroke. People on warfarin with INR consistently within the TTR (INR , TTR > 60%) will probably not benefit clinically from a switch to rivaroxaban. 3,14,15,17 Consider rivaroxaban for people who are unable to take warfarin because of: drug interactions inability to maintain dietary restrictions poor venous access for INR monitoring difficulty with regular INR monitoring.

4 4 Where does it fit? Rivaroxaban may be suitable for people with AF who do not have prosthetic heart valves or significant valvular disease, who are at increased risk of stroke and for whom warfarin is unsuitable or who cannot achieve a stable INR with warfarin. Warfarin, rivaroxaban, dabigatran and apixaban are all PBS-listed for the prevention of stroke and systemic embolism in people with NVAF and at least one other risk factor for stroke; (see also NPS Medicinewise News: Good anticoagulant practice [www.nps.org.au/medicinewise-news/ good-anticoagulant-practice]). How does it compare? The efficacy of rivaroxaban for reducing incidence of combined stroke and systemic embolism in patients with NVAF and a moderate to high risk of stroke (CHADS 2 score of 2) was compared with that of dose-adjusted warfarin in a double - blind, double-dummy, randomised controlled trial (ROCKET-AF, 1.9 years, n = 14,264). 4 Rivaroxaban non-inferior to warfarin in reducing stroke and systemic embolism In the ROCKET-AF trial, rivaroxaban was non-inferior (pre-specified margin of 1.46) to dose-adjusted warfarin in patients with NVAF and a moderate to high risk of stroke (CHADS 2 score 2) in both the intention-totreat population (all patients who underwent randomisation and were followed for events during treatment or after premature discontinuation) and the per-protocol population (all patients who received at least one dose of a study drug, did not have a major protocol violation and were followed for events occurring during the study or within 2 days after discontinuation). The superiority analysis was performed using the safety-ontreatment population (all patients who received at least one dose of a study drug, regardless of adherence to protocol and were followed for events while on study or within 2 days after discontinuation). 4,5 The efficacy of rivaroxaban was only superior to that of dose-adjusted warfarin using the safety-on-treatment population but not when analysed using the intention-to-treat population (Table 1). 4 Similar results were reported in the Japanese trial of rivaroxaban (J-ROCKET-AF), in which rivaroxaban was demonstrated to be non-inferior to warfarin. 19 Subset analyses from the ROCKET-AF study indicated the relative efficacy and safety results were consistent in patients with or without previous stroke or transient ischaemic attack. 20 Table 1. Rates of stroke or systemic emboli per year in ROCKET-AF 4,5,18 Per-protocol, as treated population* (n = 13,962) Intention-to-treat population (n = 14,171) Rivaroxaban 1.7% 2.1% 1.7% Safety-on-treatment population (n = 14,143) Warfarin 2.2% 2.4% 2.2% Hazard ratio (95% CI) 0.79 (0.66 to 0.96) 0.88 (0.75 to 1.03) 0.79 (0.65 to 0.95) Non-inferior Yes p = < Yes p = < Yes p = < Superior Not tested No p = 0.12 Yes p = 0.02 * All patients who received at least one dose of a study drug, did not have a major protocol violation and were followed for events during the study or within 2 days after discontinuation All patients who underwent randomisation and were followed for events during treatment or after premature discontinuation All patients who received at least one dose of a study drug regardless of adherence to protocol and were followed for events during the study or within 2 days after discontinuation

5 5 People with well-controlled INR on warfarin will probably not benefit clinically from switching to rivaroxaban Carefully assess people whose INR is stable within the therapeutic range (INR ) before switching to rivaroxaban. Data from the ROCKET- AF trial indicate that rivaroxaban was non-inferior to warfarin irrespective of the time the participants INR remained within therapeutic range. 5 However, in a subgroup analysis of event rates in patients whose TTR was above the clinical trial median (57.8%), rivaroxaban did not meet the definition of non-inferiority. 17 Similarly, a centre-based subgroup analysis of time below therapeutic range indicated that at sites where control of INR was very good, treatment with rivaroxaban was not as effective as treatment with warfarin. 21 This is also reflected in current international guidelines, and a switch in therapy for people who are currently well controlled by warfarin will probably not be justified on clinical grounds. 14,15 No head-to-head trials of rivaroxaban versus dabigatran Dabigatran, a direct thrombin (factor IIa) inhibitor, received a positive PBAC recommendation for PBS listing for stroke prevention in NVAF based on the results of the global dabigatran/warfarincontrolled RE-LY trial. 22 Dabigatran was PBS listed for this indication in September 2013 for additional information on dabigatran see the August 2011 issue of NPS RADAR and the Australian Prescriber article New oral anticoagulant drugs mechanisms of action. Several indirect comparative studies have been reported but interpretation of these data is problematic due to differences in study design between the two pivotal clinical trials The ROCKET-AF trial was a double-blind, doubledummy, randomised controlled trial whereas the RE-LY trial was an open-label, randomised controlled trial. 4,22 In addition, 50.4% of participants in the RE-LY trial were warfarin naïve whereas only 37.5% of ROCKET-AF trial participants were warfarin naïve. The mean CHADS 2 score of ROCKET-AF trial participants was 3.5, reflected also in the 54.9% of participants who had previous stroke, while in the RE-LY trial, participants had a mean CHADS 2 score of 2.1 and 20.3% of trial participants had a previous history of stroke. 4,22 Differing definitions of bleeding and the use of different exclusion criteria that prevented patients with certain comorbidities from entering the study, but which may be present in people presenting in routine clinical practice, are also of concern. 4,22 The higher average risk of stroke (mean CHADS 2 score 3.5) and the lower TTR observed in ROCKET-AF trial participants may not necessarily reflect the Australian population, and a patient s current INR must be taken into account when assessing the benefits of new treatments. 28 Safety issues The requirement for anticoagulation should always be balanced against risk of bleeding. As with warfarin, bleeding is the greatest safety concern with rivaroxaban. However, unlike the situation with warfarin, there is no validated test for measuring coagulation levels and there is currently no validated antidote to the effects of rivaroxaban. Avoid rivaroxaban in people who have clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding) or who have increased risk of clinically significant bleeding such as venous ulcers or intraocular lesions. Report suspected adverse reactions to the TGA online (www.ebs.tga.gov.au) or by using the Blue Card distributed three times a year with Australian Prescriber. For information about reporting adverse reactions, see the TGA website (www.tga.gov.au).

6 6 Table 2. Rates of bleeding per year in the ROCKET-AF safety-on-treatment population* 4,5 Major and non-major clinically relevant bleeding Rivaroxaban (n = 7111) 14.9% (1475) Warfarin (n = 7125) 14.5% (1449) 3.4% (386) 0.7% (84) 2.2% (154) Number needed to treat/harm (NNT/NNH) No significant difference Hazard ratio (HR) (95% CI) 1.03 (0.96 to 1.11) Major bleeding 3.6% (395) No significant difference 1.04 (0.90 to 1.20) Intracranial bleeding 0.5% (55) Gastrointestinal bleeding 3.2% (224) NNT = (0.47 to 0.93) NNH = 100 HR and CI not specified p < * Excludes 20 patients in the rivaroxaban arm and eight patients in the warfarin arm who did not take the first study dose NNT/NNH is based on events reported in the trial population over the duration of the clinical trial (1.9 years) ADDITIONAL INFORMATION Refer to this review at for more information about the Child Pugh classification of liver disease. Reduced intracranial bleeding but more GI bleeding, epistaxis and haematuria In the ROCKET-AF study the incidence of major and clinically relevant non-major bleeding was similar with rivaroxaban and dose-adjusted warfarin (Table 2). 4,5 There were significantly fewer intracranial bleeds (absolute risk reduction 0.2% per year) but gastrointestinal bleeding was significantly more common (absolute risk increase 1.0% per year). 4,5 Epistaxis and haematuria also occurred more frequently in the rivaroxaban arm (both p < 0.05). 4 No coagulation monitoring test is available for rivaroxaban Unlike the case with warfarin, INR is not predictive of the effects of rivaroxaban; INR results may be increased while a person is on rivaroxaban. 29 There are no reliable tests available to monitor anticoagulant effect or patient compliance for rivaroxaban. Prothrombin time is not a reliable test for determining either therapeutic or adverse effects of rivaroxaban. Caution required when switching from warfarin to rivaroxaban Stop warfarin, monitor INR and start rivaroxaban once INR is 3.0. Refer to the rivaroxaban product information for guidance when switching people with NVAF from warfarin to rivaroxaban. 2 Switching from rivaroxaban to warfarin and other oral anticoagulants Discontinuing rivaroxaban without introducing an adequate alternate anticoagulant places people with NVAF at increased risk of thromboembolic events, including stroke. Significantly more patients switching from rivaroxaban to warfarin than those already on warfarin had strokes during the first month after withdrawal from the ROCKET-AF study (22 vs 7, p = 0.008). 5 No clinical trial data are available to guide switching people from rivaroxaban to warfarin. As rivaroxaban affects INR, INR measurements made during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin (refer to the rivaroxaban product information for further details). 2 Rivaroxaban is contraindicated in people with: severe renal impairment both rivaroxaban 15 mg and 20 mg are contraindicated in people with creatinine clearance (CrCl) < 30 ml/min significant hepatic disease (including moderate and severe hepatic impairment, i.e. Child Pugh grade B or C) which is associated with coagulopathy leading to a clinically relevant bleeding risk. No data are available for severe hepatic impairment concomitant treatment with strong inhibitors of both CYP3A4 and P-glycoprotein. These include HIV protease inhibitors (e.g. ritonavir) or systemically administered azole antimycotics (e.g. ketoconazole).

7 7 ADDITIONAL INFORMATION Refer to this review at for more information about the Cockcroft Gault formula. For people who are using rivaroxaban, caution is required: with a known bleeding risk weigh the risk of thromboembolic events against the risk of bleeding when spinal or epidural anaesthesia or lumbar puncture is indicated, as patients may be at increased risk of spinal haematoma, which can result in long-term or permanent paralysis with concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbitone or St John s wort, as this may lead to reduced rivaroxaban plasma concentrations and increased embolic risk. Advise premenopausal women taking rivaroxaban to be aware that menstrual bleeding may be intensified and/or prolonged. Reason for PBS listing The PBAC recommended the PBS listing of rivaroxaban for the prevention of stroke in patients with NVAF on a cost-effectiveness basis compared with warfarin for the two outcomes bleeding and haemorrhagic stroke. The PBAC considered rivaroxaban to be superior to warfarin with respect to the rate of intracranial bleeding and haemorrhagic stroke. 3 The PBAC previously recommended that the submission of rivaroxaban for the prevention of stroke and systemic embolism in patients with NVAF be rejected in March At this time the PBAC considered that there was uncertainty around the clinical evidence to support the claim and resultant uncertainty in the economic analysis. 3 No dose adjustment is required for extreme body weight alone (< 50 kg or > 120 kg); however, calculate CrCl using the Cockcroft Gault formula in such cases. Close surveillance is required in people with a body weight < 50 kg. Surgery and interventions Discontinuation of rivaroxaban should be guided by clinical judgement. When possible rivaroxaban should be discontinued at least 24 hours before any procedure. Information for patients Refer to NPS Medicinewise News: Good anticoagulant practice (www.nps.org.au/medicinewise-news/ good-anticoagulant-practice). seek urgent medical attention for unexplained bruising, blood in the urine, black stools or prolonged bleeding tell their health professional at each consultation that they are taking rivaroxaban ensure compliance with the singledosing regimen, due to the short half-life of rivaroxaban take rivaroxaban with food replace a missed dose immediately on the same day and continue on the following day with the once-daily intake as before avoid non-prescription medicines containing aspirin; use paracetamol instead. Discuss the rivaroxaban (Xarelto) consumer medicine information (CMI) leaflet with the patient. Search for CMI at search_by_medicine_name. Dosing issues The recommended dose is 20 mg taken orally once daily (15 mg in moderate renal impairment, CrCl ml/min) taken with food and preferably at the same time each day. Taking rivaroxaban with food can increase the maximum plasma concentration by 76% in both the 15 mg and 20 mg strengths. 2,3 MEDICINE UPDATE An NPS Medicine Update article on Xarelto is available for consumers. Medicine Update helps consumers ask the right questions about new medicines, and helps them compare the potential benefits and harms of a new medicine with those of other medicines.

8 8 REFERENCES 1. Patel MR, et al. N Engl J Med 2011;365: Supplement to Patel MR, Mahaffey KW, et al. N Engl J Med 2011;365: Australian Government Department of Health and Ageing. March 2013 PBAC Public Summary Documents by Meeting Rivaroxaban (SPAF), tablet, 15 mg and 20 mg, Xarelto. industry/listing/elements/pbac-meetings/psd/ /rivaroxaban-spaf-psd pdf (accessed 1 August 2013). 4. Bayer Australia Ltd. Xarelto (Rivaroxaban) product information. 5. Kreutz R. Fundam Clin Pharmacol 2012;26: Mortimer CL, et al. Aust Fam Physician 2005;34: Singh P, et al. J Clin Pharm Ther 2011;36: Wang L, et al. Curr Ther Res Clin Exp 2008;69: etg complete [online]. Atrial fibrillation (amended July 2012). (accessed 18 August 2012). 10. Camm AJ, et al. Eur Heart J 2012;33: Lip GY, et al. J Am Coll Cardiol 2011;57: Pisters R, et al. Chest 2010;138: Australian Medicines Handbook 2012 (online). (accessed September 2012). 14. Canadian Agency for Drugs and Technologies in Health. CADTH Therapeutic Review Recommendations: New Oral Anticoagulants for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation media/pdf/tr0002_new-oral-anticoagulants_ rec_e.pdf (accessed 30 August 2012). 15. National Institute for Health and Clinical Excellence. TA256 Atrial fibrillation (stroke prevention) rivaroxaban: guidance nice.org.uk/ta256/guidance/pdf/english (accessed 30 August 2012). 16. You JJ, et al. Chest 2012;141:e531S 75S. 17. Australian Government Department of Health and Ageing. March 2012 PBAC Public Summary Documents by Meeting Rivaroxaban, tablet, 15 mg and 20 mg, Xarelto. internet/main/publishing.nsf/content/pbac-psdrivaroxaban-af-march12 (accessed 1 August 2013). 18. Jin M. ROCKET-AF: rivaroxaban vs Warfarin in patients with Atrial fibrillation AF-Rivaroxaban.pdf (accessed October 2012). 19. Hori M, et al. Circ J 2012;76: Hankey GJ, et al. Lancet Neurol 2012;11: U.S. Food and Drug Administration. FDA Draft Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC), UCM USA: FDA, fda.gov/downloads/advisorycommittees/ CommitteesMeetingMaterials/drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/ ucm pdf (accessed 7 September 2012). 22. Connolly SJ, et al. N Engl J Med 2009;361: Capodanno D, et al. Int J Cardiol 2012:doi: / j.ijcard Lip GY, et al. J Am Coll Cardiol 2012;60: Pengo V, et al. J Thromb Haemost 2012:doi: /j x. [e-pub]. 26. Schneeweiss S, et al. Circulation: Cardiovascular Quality and Outcomes 2012;5: Testa L, et al. QJM 2012:doi: /qjmed/ hcs114 [e-pub]. 28. Wallentin L, et al. Lancet 2010;376: Schulman S, Crowther MA. Blood 2012;119: Australian Government Department of Health and Ageing. March 2012 PBAC outcomes: decisions not to recommend. info/industry/listing/elements/pbac-meetings/ pbac-outcomes/ /1st-time-decisions (accessed 1 August 2013). Updated September 2013 to reflect PBS listing of apixaban and dabigatran for the prevention of stroke and systemic embolism in people with NVAF. Revised and updated August 2013 to reflect the changes to the PBS listing for rivaroxaban, effective 1 August 2013, and the TGA registration of apixaban for the prevention of stroke and systemic embolism in people with NVAF. First published: December 2012 The information contained in NPS RADAR is derived from a critical analysis of a wide range of authoritative evidence and is current at the time of publication. Any treatment decisions based on the information provided in NPS RADAR should be made in the context of the clinical circumstances of each patient. NPS RADAR articles may be updated when there is new evidence about safety or efficacy, or in case of regulatory or PBS listing changes. Please refer to for the most recent version as well as any supplementary information.

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