Dabigatran vs rivaroxaban for thromboprophylaxis

Size: px
Start display at page:

Download "Dabigatran vs rivaroxaban for thromboprophylaxis"

Transcription

1 Dabigatran vs rivaroxaban for thromboprophylaxis Dabigatran etexilate and rivaroxaban were both licensed recently for thromboprophylaxis following hip or knee surgery. In this article, the North Central London Formulary and Medicines Management Group review the evidence for the efficacy and safety of both drugs. Venous thromboembolism is the most serious and frequent complication of total hip and knee replacement surgery and hip fracture surgery. 1 In the absence of thromboprophylaxis, venous thromboembolism will develop in approximately 50% of patients who have undergone total hip replacement (THR) and hip fracture surgery, and in approximately 0% of patients who have undergone total knee replacement (TKR) surgery. 2 Thromboprophylaxis is therefore essential (see background box). Recently, dabigatran etexilate (Pradaxa; Boehringer Ingelheim) and rivaroxaban (Xarelto; Bayer) have been licensed for extended thromboprophylaxis after THR and TKR surgery, and the National Institute for Health and Clinical Excellence has published two technology appraisals NICE recommends that patients undergoing elective total hip (THR) or knee replacement (TKR) surgery should receive post-operative prophylaxis with either subcutaneous low molecular weight heparin (such as enoxaparin) or fondaparinux. This is given for 7 10 days after TKR surgery and for an average of 28 days after THR surgery. 3 Patients with poor renal function or at high risk of bleeding or thrombosis should receive unfractionated heparin. The value of thromboprophylaxis with unfractionated heparin (UFH) in orthopaedic surgery has been well established. Use of UFH use reduces hard primary clinical efficacy outcomes (subclinical and clinical deep vein thrombosis [DVT], clinical pulmonary embolism [PE] and fatal PE) by two-thirds. 4 Background endorsing their use for this indication. 10,11 Dabigatran is a univalent, oral, competitive, reversible, direct thrombin inhibitor which inhibits free and fibrinbound thrombin and thrombin-induced platelet aggregation. 12 It is administered as the oral prodrug dabigatran etexilate. Rivaroxaban is an oxazolidinone derivative that is an inhibitor of factor Xa. 13 By directly inhibiting factor Xa, rivaroxaban blocks both intrinsic and extrinsic pathways in the clotting process. It is also taken orally. Dabigatran efficacy The efficacy of dabigatran was assessed in two pivotal, randomised, multicentre, double-blind, double-dummy, noninferiority, phase III studies of similar design; one in patients undergoing TKR surgery (RE-MODEL) 14 and one in More recently, data has shown that the use of low molecular weight heparin (LMWH) injections have at least equivalent efficacy to UFH. 5 The incidence of DVT associated with 5 11 days of LMWH has been reported to occur in as many as 20% of patients, leading to the prescribing of extended duration prophylaxis. 7 The use of extended duration prophylaxis has reduced the incidence of asymptomatic, total and proximal DVT and symptomatic DVT by at least 50%. 8 Heparin-induced thrombocytopenia is a risk in orthopaedic patients given subcutaneous prophylactic heparin. The incidence is approximately 5% with UFH and 0.5% with LMWH 9 and is a major disadvantage associated with the use of these drugs. To receive your free copy of The British Journal of Clinical Pharmacy please return to clinicalpharmacy.org.uk and complete a subscriptions form. patients undergoing THR (RE-NOVATE). 15 The objective of these studies was to prove the non-inferiority of dabigatran to the established intervention, LMWH (enoxaparin). A non-inferiority margin of 7.7% and 9.2% was established a priori for THR and TKR surgery, respectively. If the upper limit of the 95% confidence interval for the absolute difference (with respect to the primary outcome) between dabigatran and enoxaparin did not exceed this margin, dabigatran would be regarded as noninferior, having preserved two-thirds of the 95% confidence interval difference between enoxaparin and placebo. Of the 5,595 patients randomised to either dabigatran or enoxaparin, 5,540 went on to undergo primary TKR surgery (n=2,07) or primary THR surgery (n=3,44). They were given either dabigatran etexilate (75mg or 110mg within one to four hours of completion of surgery, provided there was good haemostasis, followed by 150mg or 220mg once daily) or enoxaparin (40mg 240

2 RE-MODEL [TKR] 14 RE-NOVATE [THR] 15 DE-220 DE-150 ENX DE-220 DE-150 ENX mitt primary efficacy population (n) Total VTE and all-cause mortality [n (%)] 183 (3.4%) 213 (40.5%) 193 (37.7%) 53 (.0%) 75 (8.%) 0 (.7%) Absolute risk difference: DE versus enoxaparin [% (95% CI)] -1.3% (-7.3 to 4.) +2.8% (-3.1 to 8.7) -0.7% (-2.9 to 1.) +0.9% (-0. to 4.4) p-value < < NNT (number needed to treat) mitt secondary efficacy population (n) Major VTE and VTE-related mortality 13 (2.%) 20 (3.8%) 18 (3.5%) 28 (3.1%) 38(4.3%) 3 (3.9%) [n (%)] Absolute risk difference: DE versus enoxaparin [% (95% CI)] -1.0% (-3.1 to 1.2) +0.3% (-2.0 to 2.) -0.8% (-2.5 to 0.8) +0.4% (-1.5 to 2.2) p-value NNT Safety population (n) Major bleeding events [n (%)] 10 (1.5%) 9 (1.3%) 9 (1.3%) 23 (2.0%) 15 (1.3%) 18(1.%) Absolute risk difference versus enoxaparin (%) +0.2% 0% +0.4% -0.3% p-value NNH (number needed to harm) DE-220 = dabigatran etexilate 220mg daily; DE-150 = dabigatran etexilate 150mg daily; ENX = enoxaparin 40mg daily; mitt = modified intention-to-treat Table 1: Summary of trials of dabigatran etexilate (DE) versus enoxaparin (ENX) following total hip or knee replacement surgery subcutaneously daily, beginning the evening before surgery). Both drugs were given for six to ten days for TKR surgery and 28 to 35 days for THR. Dabigatran was initiated after a mean of 3.4 hours after surgery, with an overall median treatment duration of eight days for TKR and 33 days for THR. Concomitant treatment with low dose aspirin ( 10mg) and selective cyclooxygenase-2 inhibitors was allowed during treatment, but use of long-acting nonsteroidal anti-inflammatory drugs was not. The use of elastic compression stockings was permitted. Women of childbearing potential were excluded from the study. The primary efficacy outcome was a composite endpoint of the incidence of total venous thromboembolic events (VTE defined as venographic or symptomatic deep vein thrombosis or symptomatic pulmonary embolism) and all-cause mortality during the treatment period. Secondary efficacy endpoints included a composite of major VTE (defined as proximal deep vein thrombosis [DVT] and pulmonary embolism [PE]) and VTE-related mortality, proximal DVT, total DVT, symptomatic DVT, symptomatic PE and death during the treatment period. A bilateral venographic assessment was undertaken within 24 hours of the last oral dose and patients were followed up for three months. Sample size calculations assumed that 25% of patients would have a nonevaluable venogram in the TKR study and 35% in the THR study (the basis of these assumptions were not reported). The primary analysis set (modified intention-to-treat population) included all randomised patients who had received at least one dose of study medication, had undergone surgery and had evaluable VTE data during the treatment period, or who died during treatment. Both doses of dabigatran in both the THR and TKR studies demonstrated the non-inferiority of dabigatran with regard to the primary efficacy outcome compared with enoxaparin (see Table 1). Of the components that contributed towards the primary efficacy outcome, the largest difference was seen in the rate of asymptomatic DVT. A third, double-blind, randomised, phase III, non-inferiority study (RE-MOBILIZE) has been conducted comparing the safety and efficacy of dabigatran (dosed as above) versus enoxaparin (30mg twice daily) in reducing the risk of VTE following TKR. 1 The inclusion criteria and the primary and secondary efficacy outcomes were defined as for the RE-MODEL and RE-NOVATE trials. In this trial however, in the 1,89 patients analysed, both doses of dabigatran failed to meet the pre-defined criteria to demonstrate non-inferior efficacy to enoxaparin (composite of total VTE was 31% for dabigatran 220mg daily [p=0.02]; 34% for dabigatran 150mg daily [p<0.001]; and 25% for enoxaparin). Rivaroxaban efficacy Four large phase III randomised, doubleblind, double-dummy studies of similar design have compared rivaroxaban with enoxaparin for the prevention of VTE after THR surgery (RECORD-1 17 & RECORD-2 18 ) or TKR (RECORD-3 19 & RECORD-4 20 ) surgery. As with the RE-MODEL and RE-NOVATE studies, September 2009 Vol. 1 The British Journal of Clinical Pharmacy 241

3 RECORD-1 [THR] 17 RECORD-2 [THR] 18 RECORD-3 [TKR] 19 RECORD-4 [TKR] 20 RVB ENX RVB ENX RVB ENX RVB ENX mitt primary efficacy population (n) Any DVT, non-fatal PE, or death [n (%)] Weighted absolute risk difference versus enoxaparin [% (95% CI)] 18 (1.1%) 58 (3.7%) 17 (2.0%) 81 (9.3%) -2.% (-1.5 to -3.7) -7.3% (-5.2 to -9.4) 79 (9.%) 1 (18.9%) -9.2% (-12.4 to -5.9) 7 (.9%) 97 (10.1%) -3.2% (-5.7 to -0.7) p-value <0.001 <0.001 < NNT (number needed to treat) Pooled (weighted) NNT 20 1 mitt secondary efficacy population (n) Major VTE [n (%)] 4 (0.2%) 33 (2.0%) (0.%) 49 (5.1%) 9 (1.0%) 24 (2.%) 13 (1.2%) 22 (2.0%) Weighted absolute risk difference versus -1.7% (-2.5 to -1.0) -4.5% (-.0 to -3.0) -1.% (-2.8 to -0.4) -0.8% (-1.82 to 0.22) enoxaparin [% (95% CI)] p-value <0.001 < NNT Pooled (weighted) NNT Safety population (n) Major bleeding events [n (%)] (0.3%) 2 (0.1%) 1 (<0.1%) 1 (<0.1%) 7 (0.%) (0.5%) 0.7% 0.3% Absolute risk difference versus enoxaparin (%) +0.2% +0.1% +0.4% p-value NNH (number needed to harm) Pooled (weighted) NNH Table 2: Summary of trials of rivaroxaban (RVB) versus enoxaparin (ENX) following total hip or knee replacement surgery the objective was to demonstrate the noninferiority of rivaroxaban to the established intervention, LMWH (enoxaparin). The non-inferiority margin established a priori for the primary efficacy endpoint was 3.5%, 4.4%, 4% and 4% for RECORD-1, 2, 3 and 4, respectively. All patients underwent mandatory bilateral venography on the day after the last dose of study medication. The primary endpoint in all studies was the composite of any DVT (symptomatic or asymptomatic, as detected by venography), non-fatal PE, or death from any cause. The main secondary endpoint was major VTE defined as the composite of proximal DVT, non-fatal PE, or VTE-related death. RECORD 1 3 Patients were randomised to receive rivaroxaban (10mg orally once daily, starting six to eight hours after wound closure) plus placebo injections or enoxaparin (40mg subcutaneously once daily, starting 12 hours pre-operatively and restarted six to eight hours after wound closure) plus placebo tablets. The duration of active study medication was as follows: RECORD-1 (THR): rivaroxaban and enoxaparin were continued for 35±4 days RECORD-2 (THR): rivaroxaban was continued for 35±4 days and enoxaparin for 12±2 days RECORD-3 (TKR): rivaroxaban and enoxaparin were continued for 12±2 days RECORD-4 Patients were randomised to receive either rivaroxaban (10mg orally, once daily) plus placebo injections or enoxaparin (30mg subcutaneously, twice daily) plus placebo tablets, starting six to eight hours and 12 to 24 hours after wound closure, respectively. Rivaroxaban and enoxaparin were continued for 12±2 days. All studies demonstrated superiority of rivaroxaban with regards to the primary efficacy endpoint, compared to enoxaparin (see Table 2). Of the components that contributed towards the primary efficacy endpoint, the largest difference was seen in the rate of asymptomatic DVT. Although all studies included an a priori statistical analysis to recruit enough patients to account for a 25% dropout rate (as a result of the inability to obtain valid venograms), the actual non-evaluable rate was slightly higher (2 30%). RECORD-1 and RECORD-3 recruited extra patients to compensate for this and thus maintain statistical power. However, this was not done in RECORD-2 or RECORD-4 and therefore has implications for the validity of the final results; although sensitivity analyses suggest that the missing data did not affect the power of the study or bias the outcome. 242

4 Safety Dabigatran The primary safety outcome in RE-MODEL and RE-NOVATE was the occurrence of bleeding events (major bleeding events, clinically relevant non-major bleeding events and minor bleeding events) during study treatment. An experienced and independent committee of experts, blinded to all treatment allocations, adjudicated all bleeding events centrally, using pre-defined and detailed rules. There was no significant difference in bleeding events between either dose of dabigatran and enoxaparin. Most major bleeding events were at the surgical wound site (89% in the TKR study and 91% in the THR study). There were no fatal bleeding events in the TKR study and two in the THR study (0.09%; one in each of the dabigatran groups). The incidence of hepatotoxicity and cardiac events was low in both studies and comparable to enoxaparin. The most common reason for treatment discontinuation was gastrointestinal disorders (nausea, vomiting and constipation) in the THR study and acute coronary events (unstable angina, myocardial infarction and cardiac death) in the TKR study, although these events were comparable between all three arms of the studies (DE-220, DE-150 and ENX). Rivaroxaban The main safety outcome of the four RECORD studies was the incidence of major bleeding, defined as bleeding that was fatal, bleeding that occurred in a critical organ or required re-operation, or sitebleeding with a fall in haemoglobin level of >2g/dL, requiring blood transfusion. The incidence of major bleeding across all studies was low (<0.1% to 0.7%) and did not differ significantly between rivaroxaban and enoxaparin. The incidences of ontreatment bleeding and non-major bleeding were not significantly different between the two treatment groups. Since different criteria were used to assess bleeding events in the RECORD (rivaroxaban) and RE-MODEL/RE- NOVATE (dabigatran) studies, it is not possible to directly compare their safety profiles (bleeding risk). However, no significant differences were observed. No differences were reported between rivaroxaban and enoxaparin in liver function test results. In the RECORD 2 study, an apparent excess of cardiovascular adverse events was noted after discontinuation of rivaroxaban (five patients [0.4%], including two deaths of cardiovascular origin). No cardiovascular adverse events were noted after discontinuation of enoxaparin. Although this trend was not observed in the other three studies, the reporting of these events raises concern about the potential for rebound activation of coagulation following discontinuation of rivaroxaban. The number of patients treated in the trials may be too few to realise the true incidence in clinical practice. A prospective, randomised, doubleblind, double-dummy, crossover study investigating the potential for rivaroxaban to cause QTc prolongation in healthy subjects (n=50; age 50) concluded that rivaroxaban does not prolong the QTc interval. 21 A study published in abstract form only (in vitro analysis) has indicated that recombinant factor VIIa can be used to partially reverse the effects of rivaroxaban (reverse the inhibition of thrombin generated). 22 Convenience Dabigatran and rivaroxaban offer the advantage of being oral preparations that do not require regular platelet monitoring, dose adjustment, or daily subcutaneous injections. Rivaroxaban has an advantage over dabigatran since it can be used in patients with a creatinine clearance of Drug appraisal articles University College London Hospitals NHS Foundation Trust, Royal Free Hampstead NHS Trust and The Whittington Hospital NHS Trust operate a centralised medication review scheme for assessing formulary applications to their Use of Medicine and Drugs and Therapeutics Committees. A review of selected formulary applications are published regularly in The British Journal of Clinical Pharmacy. These reviews are intended to inform readers about the individual merits and limitations of the drugs in question, and to provide examples of in-depth, critical reviewing which can be adapted and used in all areas of evidence-based medicine ml/minute (with caution, based on limited clinical data). Moreover, the dosing schedule for rivaroxaban is more simple than that of dabigatran and is more appropriate for patients undergoing surgery with an epidural. When epidural anaesthesia is used, concomitant use of anti-thrombotic drugs can increase the risk of developing a haematoma, which can result in longterm or permanent paralysis. Dabigatran is licensed to be given one to four hours post surgery. In practice this is likely to be given later in patients who have had epidural anaesthesia, so the drug will effectively be used off-label. Rivaroxaban is licensed for administration six to eight hours post surgery. Since rivaroxaban is a substrate for the hepatic enzyme CYP3A4, concomitant administration with drugs that are known inhibitors of this enzyme is not recommended. Dabigatran is not metabolised by the cytochrome P450 system so may be a more appropriate choice for patients on potentially interacting medication. However, since dabigatran is a substrate for the efflux transporter P-glycoprotein, its plasma level is noted to increase by up to 50% with the co-administration of medicines that are inhibitors of this transporter, notably amiodarone. This interaction (increased risk of bleeding) may be of greater relevance in practice when considering the target population elderly people who are more likely to have a co-existing cardiovascular condition requiring treatment with amiodarone. The clinical significance of these interactions in clinical practice are yet to be determined. Cost One month s supply of rivaroxaban costs approximately 135 and one month s supply of dabigatran costs approximately 125. Although prescribing of these oral agents will result in a cost burden with regard to drug acquisition costs, this should offset the indirect costs associated with the use of LMWH, such as nursing time for administration (both in hospital and in the community), sharps bins, swabs, delayed discharges, laboratory monitoring costs, and increased GP visits or outpatient clinic appointments. Cost-utility analyses conducted by NICE concluded that both dabigatran September 2009 Vol. 1 The British Journal of Clinical Pharmacy 243

5 and rivaroxaban represent a cost-effective alternative to LMWH in the prophylaxis of VTE associated with THR or TKR. However, given the historical difficulties in implementing extended prophylaxis with a LMWH, it is likely that the initial changeover to an oral agent will result in a more significant initial cost impact than the incremental cost-effectiveness ratios calculated within the NICE technology appraisals. Conclusion Although there are no direct comparative data on the efficacy and safety of rivaroxaban versus dabigatran, rivaroxaban demonstrated superiority over the LMWH enoxaparin, whereas dabigatran trials only demonstrated non-inferiority. In terms of safety, no clear significant differences between dabigatran and rivaroxaban are observed. Since rivaroxaban also appears more convenient in both its administrative schedule (following epidural) and clinical use (in mild/ moderate renal impairment), the University College London Hospitals NHS Foundation Trust Use of Medicines Committee approved the use of rivaroxaban in place of LMWH for extended thromboprophylaxis after THR and TKR surgery. Written by Anthony Grosso, principal pharmacist and Pritesh Bodalia, senior pharmacist, at University College London Hospitals NHS Foundation Trust. Acknowledgement: Carolyn Gates, senior pharmacist, UCLH. Conflicts of interest: none declared. References 1. White RH, Romano PS, Zhou H, Rodrigo J, Bargar W. Incidence and time course of thromboembolic outcomes following total hip or knee arthroplasty. Arch Intern Med 1998;158: Kwong LM. Venous thromboembolism following major orthopaedic surgery getting the bigger picture. Orthopaedic Surgery: US Musculoskeletal Review 200: National Institute for Health and Clinical Excellence. Venous thromboembolism Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery. London:NICE; Collins R, Scrimgeour A, Yusuf S, Peto R. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin. Overview of results of randomized trials in general, orthopedic, and urologic surgery. N Engl J Med 1988;318: Koch A, Bouges S, Ziegler S, Dinkel H, Daures JP, Victor N. Low molecular weight heparin and unfractionated heparin in thrombosis prophylaxis after major surgical intervention: update of previous meta-analyses. Br J Surgery 1997;84: Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell C et al. Prevention of venous thromboembolism: the seventh ACCP conference on antithrombotic and thrombolytic therapy. Chest 2004;12:338S 400S. 7. Eikelboom JW, Quinlan DJ, Douketis JD. Extended duration prophylaxis against venous thromboembolism after total hip or knee replacement: a meta-analysis of the randomised trials. Lancet 2001;358: Cohen AT, Bailey CS, Alikhan R, Cooper DJ. Extended thromboprophylaxis with LMWH reduces symptomatic venous thromboembolism following lower-limb arthroplasty a meta-analysis. Thrombosis and Haemostasis 2001;85: Warkentin T, Sheppard J, Horsewood P, Simpson PJ, Moore JC, Kelton JG. Impact of the patient population on the risk for heparin-induced thrombocytopenia. Blood 2000;9: National Institute for Health and Clinical Excellence. Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults. NICE technology appraisal guidance 157. London: NICE; National Institute for Health and Clinical Excellence. Rivaroxaban for the prevention of venous thromboembolism after hip or knee replacement surgery in adults. NICE technology appraisal guidance 170. London: NICE; Nisio MD, Middeldorp S, Buller HR. Direct thrombin inhibitors. New Eng J Med 2005; 353: Chen T, Lam S. Rivaroxaban: An oral direct factor Xa inhibitor for the prevention of thromboembolism. Cardiol Rev 2009;17: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP et al, for the RE-MODEL study group. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP et al, for the RE-NOVATE study group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, noninferiority trial. Lancet 2007;370: Ginsburg JS, Davidson Bl, Comp PC, Francis CW, Friedman RJ, Huo MH et al (the RE- MOBILIZE writing committee). Oral thrombin inhibitor dabigatran etexilate vs north american enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009;24: Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK et al, for the RECORD-1 study group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Eng J Med 2008;358: Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, et al, for the RECORD-2 investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a doubleblind, randomised controlled trial. Lancet 2008;372: Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ et al, for the RECORD-3 investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Eng J Med 2008;358: Turpie AGG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM et al, for the RECORD-4 investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty: A randomised trial. Lancet 2009;373: Kubitza D, Mueck W, Becka M. Randomised, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation. Drug Safety 2008;31: Perzborn E, Harwardt M. Recombinant factor VIIa partially reverses the effects of the factor Xa inhibitor rivaroxaban on thrombin generation, but not the effects of thrombin inhibitors (in vitro). J Thromb Haemost 2007; 5(Suppl 2): Abstract P-W-40. Commentary article An article on p245 reflects on the increasing use of trials designed as noninferiority studies. 244

Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal

Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal DOI: 10.3310/hta13suppl3/07 Health Technology Assessment 2009; Vol. 13: Suppl. 3 Rivaroxaban for the prevention of venous thromboembolism: a single technology appraisal M Stevenson,* A Scope, M Holmes,

More information

DATE: 06 May 2013 CONTEXT AND POLICY ISSUES

DATE: 06 May 2013 CONTEXT AND POLICY ISSUES TITLE: Low Molecular Weight Heparins versus New Oral Anticoagulants for Long-Term Thrombosis Prophylaxis and Long-Term Treatment of DVT and PE: A Review of the Clinical and Cost-Effectiveness DATE: 06

More information

About the RECORD Clinical Trial Program

About the RECORD Clinical Trial Program About the RECORD Clinical Trial Program Fast facts RECORD was a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism

More information

ABOUT XARELTO CLINICAL STUDIES

ABOUT XARELTO CLINICAL STUDIES ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the

More information

Randomized, double-blind, parallel-group, multicenter, doubledummy

Randomized, double-blind, parallel-group, multicenter, doubledummy ABOUT RECORD STUDIES FAST FACTS RECORD is a global program of four trials in more than 12,500 patients, comparing Xarelto (rivaroxaban) and enoxaparin in the prevention of venous thromboembolism (VTE)

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Pharmacological prophylaxis for venous thromboembolism

Pharmacological prophylaxis for venous thromboembolism Pharmacological prophylaxis for venous thromboembolism Essence of this ArticleFor more than 20 years, routine preventive anticoagulant therapy has been the standard of care after major orthopaedic surgery.

More information

Evidence Review. New Oral Anticoagulants. Background. Search for non-cochrane reviews and RCTs.

Evidence Review. New Oral Anticoagulants. Background. Search for non-cochrane reviews and RCTs. Evidence Review Created on: October 01, 2009 Topic: New Oral Anticoagulants Background Elective total hip arthroplasty (THA) and total knee arthroplasty (TKA) are associated with a high risk of postoperative

More information

The novel anticoagulants: entering a new era

The novel anticoagulants: entering a new era Review article Peer reviewed article SWISS MED WKLY 2009;139(5 6):60 64 www.smw.ch 60 The novel anticoagulants: entering a new era Henri Bounameaux Division of Angiology and Haemostasis, Department of

More information

Review Article The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and Total Knee Arthroplasty

Review Article The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and Total Knee Arthroplasty Thrombosis Volume 2013, Article ID 762310, 5 pages http://dx.doi.org/10.1155/2013/762310 Review Article The Efficacy and Safety of Rivaroxaban for Venous Thromboembolism Prophylaxis after Total Hip and

More information

Cost Effectiveness of Apixaban (Eliquis ) for the Prevention of Venous Thromboembolic Events in Adult Patients who have Undergone Elective Total Hip

Cost Effectiveness of Apixaban (Eliquis ) for the Prevention of Venous Thromboembolic Events in Adult Patients who have Undergone Elective Total Hip Cost Effectiveness of Apixaban (Eliquis ) for the Prevention of Venous Thromboembolic Events in Adult Patients who have Undergone Elective Total Hip Replacement or Total Knee Replacement National Centre

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Prior Authorization Guideline

Prior Authorization Guideline Guideline Guideline Name Formulary Xarelto (rivaroxaban) UnitedHealthcare Community & State Approval Date 0/0/203 Revision Date 8//204 Technician Note: CPS Approval Date: /5/20; CPS Revision Date: 8/20/204

More information

Breadth of indications matters One drug for multiple indications

Breadth of indications matters One drug for multiple indications Breadth of indications matters One drug for multiple indications Sylvia Haas, MD, PhD Formerly of the Technical University of Munich Munich, Germany Disclosures: Sylvia Haas 1 Novel oral anticoagulants:

More information

Rivaroxaban (Xarelto) for preventing venous thromboembolism after hip or knee replacement surgery

Rivaroxaban (Xarelto) for preventing venous thromboembolism after hip or knee replacement surgery for preventing venous thromboembolism after hip or knee replacement surgery (riv-ah-rocks-ah-ban) Summary Rivaroxaban is an oral anticoagulant and the first direct factor Xa inhibitor. Rivaroxaban has

More information

EXTENDED PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN MAJOR SURGERY. 1) Postoperative venous thromboembolism: a continuing problem after discharge?

EXTENDED PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN MAJOR SURGERY. 1) Postoperative venous thromboembolism: a continuing problem after discharge? 1 EXTENDED PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN MAJOR SURGERY 1) Postoperative venous thromboembolism: a continuing problem after discharge? Studies from the late 80 s and early 90 s pointed to the

More information

Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012

Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012 Rivaroxaban A new oral anti-thrombotic Dr. Hisham Aboul-Enein Professor of Cardiology Benha University 12/1/2012 Agenda Ideal anticoagulant. Drawbacks of warfarin. Rivaroxaban in clinical trails. Present

More information

Thrombosis and Hemostasis

Thrombosis and Hemostasis Thrombosis and Hemostasis Wendy Lim, MD, MSc, FRCPC Associate Professor, Department of Medicine McMaster University, Hamilton, ON Overview To review the important developments in venous thromboembolism

More information

Rivaroxaban, an Oral, Direct Factor Xa Inhibitor: A New Option for Thromboprophylaxis

Rivaroxaban, an Oral, Direct Factor Xa Inhibitor: A New Option for Thromboprophylaxis n Feature Article, an Oral, Direct Factor Xa Inhibitor: A New Option for Thromboprophylaxis Louis M. Kwong, MD, FACS abstract Full article available online at Healio.com/Orthopedics. Search: 20120525-38

More information

Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM

Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM This report was commissioned by the NIHR HTA Programme as project number 12/78

More information

CDEC FINAL RECOMMENDATION

CDEC FINAL RECOMMENDATION CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Pulmonary Embolism Note: The Canadian Drug Expert Committee (CDEC) previously reviewed rivaroxaban for the treatment of deep vein

More information

Are there sufficient indications for switching to new anticoagulant agents

Are there sufficient indications for switching to new anticoagulant agents Are there sufficient indications for switching to new anticoagulant agents Meyer Michel Samama et Gregoris Gerotziafas Groupe Hémostase-Thrombose Hôtel-Dieu, Hôpital Tenon, Paris & Biomnis Ivry/seine,

More information

Committee Approval Date: September 12, 2014 Next Review Date: September 2015

Committee Approval Date: September 12, 2014 Next Review Date: September 2015 Medication Policy Manual Policy No: dru361 Topic: Pradaxa, dabigatran Date of Origin: September 12, 2014 Committee Approval Date: September 12, 2014 Next Review Date: September 2015 Effective Date: November

More information

rivaroxaban 15 and 20mg film-coated tablets (Xarelto ) SMC No. (755/12) Bayer PLC

rivaroxaban 15 and 20mg film-coated tablets (Xarelto ) SMC No. (755/12) Bayer PLC rivaroxaban 15 and 20mg film-coated tablets (Xarelto ) SMC No. (755/12) Bayer PLC 13 January 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS

More information

Uncontrolled when printed. Version 1.1. Acute Sector. Lead Author/Co-ordinator: Mr Simon Barker Consultant Orthopaedic Surgeon Julie Fraser

Uncontrolled when printed. Version 1.1. Acute Sector. Lead Author/Co-ordinator: Mr Simon Barker Consultant Orthopaedic Surgeon Julie Fraser Acute Sector NHS Grampian Staff Local Treatment Protocol For Venous Thromoboembolic Prophylaxis Using Rivaroxaban 10mg Tablets In Adult Patients Undergoing Elective Hip Or Knee Replacement Surgery. Lead

More information

Dabigatran and rivaroxaban, new oral anticoagulants. new approaches in dentistry

Dabigatran and rivaroxaban, new oral anticoagulants. new approaches in dentistry Journal section: Oral Medicine and Pathology Publication Types: Research doi:10.4317/jced.2.e1 Dabigatran and rivaroxaban, new oral anticoagulants. new approaches in dentistry Gerardo Gómez-Moreno 1, Antonio

More information

Published 2011 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018. AAOS Clinical Practice Guidelines Unit

Published 2011 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018. AAOS Clinical Practice Guidelines Unit Volume 4. AAOS Clinical Guideline on Preventing Venous Thromboembolic Disease in Patients Undergoing Elective Hip and Knee Arthroplasty Comparison with Other Guidelines Disclaimer This clinical guideline

More information

Eliquis. Policy. covered: Eliquis is. indicated to. reduce the. therapy. Eliquis is. superior to. of 32 to. Eliquis is AMPLIFY. nonfatal. physicians.

Eliquis. Policy. covered: Eliquis is. indicated to. reduce the. therapy. Eliquis is. superior to. of 32 to. Eliquis is AMPLIFY. nonfatal. physicians. Eliquis (apixaban) Policy Number: 5.01.573 Origination: 06/2014 Last Review: 07/2015 Next Review: 07/2016 Policy BCBSKC will provide coverage for Eliquis when it is determined to be medically necessary

More information

THE BENEFITS OF RIVAROXABAN (XARELTO ) ACROSS MULTIPLE INDICATIONS AND THE RELEVANCE TO CARDIOLOGISTS

THE BENEFITS OF RIVAROXABAN (XARELTO ) ACROSS MULTIPLE INDICATIONS AND THE RELEVANCE TO CARDIOLOGISTS THE BENEFITS OF RIVAROXABAN (XARELTO ) ACROSS MULTIPLE INDICATIONS AND THE RELEVANCE TO CARDIOLOGISTS Ingo Ahrens, Christoph Bode Cardiology and Angiology I, Heart Center Freiburg University, Freiburg,

More information

Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical

Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Center A.Fib affects 2.2 million Americans. The lifetime

More information

2. Background This indication of rivaroxaban had not previously been considered by the PBAC.

2. Background This indication of rivaroxaban had not previously been considered by the PBAC. PUBLIC SUMMARY DOCUMENT Product: Rivaroxaban, tablets, 15mg and 20mg, Xarelto Sponsor: Bayer Australia Ltd Date of PBAC Consideration: March 2013 1. Purpose of Application The application requested the

More information

Therapeutic Class Overview Oral Anticoagulants

Therapeutic Class Overview Oral Anticoagulants Therapeutic Class Overview Oral Anticoagulants Therapeutic Class Overview/Summary: The oral anticoagulants, dabigatran etexilate mesylate (Pradaxa ), rivaroxaban (Xarelto ), and warfarin (Coumadin, Jantoven

More information

(a) New Oral Anticoagulants & (b) Neuropathic Pain

(a) New Oral Anticoagulants & (b) Neuropathic Pain Evidence Updates: (a) New Oral Anticoagulants & (b) Neuropathic Pain Brendalynn Ens, RN, MN, CCN(c) CADTH-Saskatchewan Gaetanne Murphy, BSc Pharm CADTH-Edmonton CADTH s Programs HTA CDR Health Technology

More information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 10 March 2010

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 10 March 2010 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 10 March 2010 ARIXTRA 1.5 mg/0.3 ml, solution for injection in pre-filled syringe Box of 2 (CIP: 363 500-6) Box of

More information

East Kent Prescribing Group

East Kent Prescribing Group East Kent Prescribing Group Rivaroxaban (Xarelto ) Safety Information Approved by the East Kent Prescribing Group. Approved by: East Kent Prescribing Group (Representing Ashford CCG, Canterbury and Coastal

More information

Drug Utilisation Review

Drug Utilisation Review Drug Utilisation Review Prescriber Drug Utilisation Reviews consider new developments in therapeutics. The information is intended to help formulary decision makers in their evidence-based assessment of

More information

DVT/PE Management with Rivaroxaban (Xarelto)

DVT/PE Management with Rivaroxaban (Xarelto) DVT/PE Management with Rivaroxaban (Xarelto) Rivaroxaban is FDA approved for the acute treatment of DVT and PE and reduction in risk of recurrence of DVT and PE. FDA approved indications: Non valvular

More information

Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement

Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement B. I. Eriksson, A. K. Kakkar, A. G. G. Turpie, M. Gent, T.-J. Bandel, M. Homering, F. Misselwitz,

More information

rivaroxaban 15mg and 20mg film-coated tablets (Xarelto ) SMC No. (852/13) Bayer plc

rivaroxaban 15mg and 20mg film-coated tablets (Xarelto ) SMC No. (852/13) Bayer plc rivaroxaban 15mg and 20mg film-coated tablets (Xarelto ) SMC No. (852/13) Bayer plc 08 February 2013 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises

More information

Rivaroxaban. Outline

Rivaroxaban. Outline Rivaroxaban Shaikha Al Naimi Pharmacy student College of Pharmacy Qatar University December 21, 2011 Outline Background Drug description Mechanism of Action Indication Pharamcokinetics Adverse Drug Reactions

More information

Bios 6648: Design & conduct of clinical research

Bios 6648: Design & conduct of clinical research Bios 6648: Design & conduct of clinical research Section 1 - Specifying the study setting and objectives 1. Specifying the study setting and objectives 1.0 Background Where will we end up?: (a) The treatment

More information

Failure or significant adverse effects to all of the alternatives: Eliquis and Xarelto

Failure or significant adverse effects to all of the alternatives: Eliquis and Xarelto This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics

More information

The Role of the Newer Anticoagulants

The Role of the Newer Anticoagulants The Role of the Newer Anticoagulants WARFARIN = Coumadin DAGIBATRAN = Pradaxa RIVAROXABAN = Xarelto APIXABAN = Eliquis INDICATION DABIGATRAN (Pradaxa) RIVAROXABAN (Xarelto) APIXABAN (Eliquis) Stroke prevention

More information

Rivaroxaban (Xarelto) in the management of stroke and DVT

Rivaroxaban (Xarelto) in the management of stroke and DVT Rivaroxaban (Xarelto) in the management of stroke and DVT Steve Chaplin MSc, MRPharmS, Victoria Haunton BM, DGM, MRCP, Thompson Robinson BMedSci, MD, FRCP and Catherine Bagot MD, FRCPath KEY POINTS is

More information

New Oral Anticoagulants

New Oral Anticoagulants New Oral Anticoagulants Tracy Minichiello, MD Associate Professor of Medicine Chief, San FranciscoVA Anticoagulation and Thrombosis Service Ansell, J. Hematology Copyright 2010 American Society of Hematology.

More information

Σάββας Σουρμελής Διευθυντής Β Ορθοπαιδικής Κλινικής ΔΘΚΑ «Υγεία»

Σάββας Σουρμελής Διευθυντής Β Ορθοπαιδικής Κλινικής ΔΘΚΑ «Υγεία» Σάββας Σουρμελής Διευθυντής Β Ορθοπαιδικής Κλινικής ΔΘΚΑ «Υγεία» 193s Heparin 194s 198s Low-molecularweight heparin Vitamin K antagonists 199s Direct thrombin inhibitors 22 Indirect Xa inhibitor 24 Oral

More information

Dabigatran etexilate: a new thrombin inhibitor

Dabigatran etexilate: a new thrombin inhibitor Dabigatran etexilate: a new thrombin inhibitor Abhishek K Verma Patients undergoing major orthopaedic surgery such as lower limb joint arthroplasty have traditionally been regarded as being at high risk

More information

Low Molecular Weight Heparin. All Wales Medicines Strategy Group (AWMSG) Recommendations and advice

Low Molecular Weight Heparin. All Wales Medicines Strategy Group (AWMSG) Recommendations and advice Low Molecular Weight Heparin All Wales Medicines Strategy Group (AWMSG) Recommendations and advice Starting Point Low Molecular Weight Heparin (LMWH): Inhibits factor Xa and factor IIa (thrombin) Small

More information

Novel Oral Anticoagulants for Venous Thromboembolism Prophylaxis After Total Hip or Knee Replacement

Novel Oral Anticoagulants for Venous Thromboembolism Prophylaxis After Total Hip or Knee Replacement Novel Oral Anticoagulants for Venous Thromboembolism Prophylaxis After Total Hip or Knee Replacement An Update on Rivaroxaban (Xarelto) Zachar y Stacy, PharmD, BCPS Key words: total hip replacement, total

More information

Comparison between New Oral Anticoagulants and Warfarin

Comparison between New Oral Anticoagulants and Warfarin Comparison between New Oral Anticoagulants and Warfarin Warfarin was the mainstay of oral anticoagulant therapy until the recent discovery of more precise targets for therapy. In recent years, several

More information

Cardiovascular Disease

Cardiovascular Disease Cardiovascular Disease 1 Cardiovascular Disease 1. More target specific oral anticoagulants (TSOAC) 2. Vorapaxar (Zonivity) 3. Continued noise about a polypill 4. WATCHMAN 3 1 2 3 4 Left Atrial Appendage

More information

XARELTO (rivaroxaban tablets) in Knee and Hip Replacement Surgery

XARELTO (rivaroxaban tablets) in Knee and Hip Replacement Surgery XARELTO (rivaroxaban tablets) in Knee and Hip Replacement Surgery Fast Facts: XARELTO is a novel, once-daily, oral anticoagulant recently approved in the United States for the prevention (prophylaxis)

More information

Pharmacoeconomic implications of thromboprophylaxis with new oral anticoagulants

Pharmacoeconomic implications of thromboprophylaxis with new oral anticoagulants Pharmacoeconomic implications of thromboprophylaxis with new oral anticoagulants after total hip or knee replacement in the United States Submitted to: Expert Opin Pharmacother Running head: Pharmacoeconomic

More information

Time of Offset of Action The Trial

Time of Offset of Action The Trial New Antithrombotic Agents DISCLOSURE Relevant Financial Relationship(s) Speaker Bureau - None Consultant Amgen Tom DeLoughery, MD FACP FAWM Oregon Health and Sciences University What I am Talking About

More information

TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation

TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation Service Notification in response to DHSSPS endorsed NICE Technology Appraisals TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation 1 Name of Commissioning

More information

Should new oral anticoagulants replace low-molecular-weight heparin for thromboprophylaxis in orthopaedic surgery?

Should new oral anticoagulants replace low-molecular-weight heparin for thromboprophylaxis in orthopaedic surgery? Archives of Cardiovascular Disease (2009) 102, 327 333 REVIEW Should new oral anticoagulants replace low-molecular-weight heparin for thromboprophylaxis in orthopaedic? Les nouveaux anticoagulants vont-ils

More information

Position Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery

Position Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery Position Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery Position Statement There is currently insufficient data for the (AOFAS) to recommend for or against routine VTED prophylaxis for

More information

Practice Pearls in the Changing Face of Anticoagulant Therapy

Practice Pearls in the Changing Face of Anticoagulant Therapy Practice Pearls in the Changing Face of Anticoagulant Therapy A midday symposium about the use of anticoagulation to prevent venous thromboembolism (VTE) was held at and broadcast live from the 44th ASHP

More information

Rivaroxaban for acute coronary syndromes

Rivaroxaban for acute coronary syndromes Northern Treatment Advisory Group Rivaroxaban for acute coronary syndromes Lead author: Nancy Kane Regional Drug & Therapeutics Centre (Newcastle) May 2014 2014 Summary Current long-term management following

More information

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors News Release For use outside the US and UK only Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com Bayer s Xarelto Approved in the EU for the Prevention of Stroke in Patients

More information

Medication Policy Manual. Topic: Eliquis, apixaban Date of Origin: July 12, 2013. Committee Approval Date: July 11, 2014 Next Review Date: July 2015

Medication Policy Manual. Topic: Eliquis, apixaban Date of Origin: July 12, 2013. Committee Approval Date: July 11, 2014 Next Review Date: July 2015 Medication Policy Manual Policy No: dru313 Topic: Eliquis, apixaban Date of Origin: July 12, 2013 Committee Approval Date: July 11, 2014 Next Review Date: July 2015 Effective Date: August 1, 2014 IMPORTANT

More information

Anticoagulant therapy

Anticoagulant therapy Anticoagulation: The risks Anticoagulant therapy 1990 2002: 600 incidents reported 120 resulted in death of patient 92 deaths related to warfarin usage 28 reports related to heparin usage Incidents in

More information

New anticoagulants for the prevention and therapy of venous thromboembolism a review

New anticoagulants for the prevention and therapy of venous thromboembolism a review New anticoagulants for the prevention and therapy of venous thromboembolism a review Nazanin Sédille-Mostafaie, Wolfgang Korte Centre for Laboratory Medicine, Kantonsspital St. Gallen, Switzerland Summary

More information

Advanced Issues in Peri-Operative VTE Prevention

Advanced Issues in Peri-Operative VTE Prevention Advanced Issues in Peri-Operative VTE Prevention Michael-Anthony (M-A) Williams, M.D. Consultant Physician Centura Medical Consultants September 27th, 2012 Main Topics 1. The perils of the early mover-

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S.

Investor News. Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint. Not intended for U.S. Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Phase III J-ROCKET AF Study of Bayer s Xarelto (rivaroxaban) Meets Primary Endpoint

More information

Dabigatran & Rivaroxaban Rat Poison in Better Packaging?

Dabigatran & Rivaroxaban Rat Poison in Better Packaging? & Rat oison in Better ackaging? Declaration have no conflicts of interest to declare Rochelle M Gellatly BSc(harm), AR, harmd linical harmacy Specialist, ardiac Surgery St. aul s Hospital, rovidence Health

More information

The direct factor Xa inhibitor rivaroxaban

The direct factor Xa inhibitor rivaroxaban The direct factor Xa inhibitor rivaroxaban Abhishek K Verma and Timothy A Brighton Since the 1920s, when heparin was discovered by a medical student in liver cell extracts and warfarin was synthesised

More information

New Oral Anticoagulants. How safe are they outside the trials?

New Oral Anticoagulants. How safe are they outside the trials? New Oral Anticoagulants How safe are they outside the trials? Objectives The need for anticoagulant therapy Indications for anticoagulation Traditional anticoagulant therapies Properties of new oral anticoagulants

More information

Xarelto (Rivaroxaban): Effective in a broad spectrum. Joep Hufman, MD Medical Scientific Liason

Xarelto (Rivaroxaban): Effective in a broad spectrum. Joep Hufman, MD Medical Scientific Liason Xarelto (Rivaroxaban): Effective in a broad spectrum Joep Hufman, MD Medical Scientific Liason Xarelto : Effective in a broad spectrum Introduction Therapeutic areas SPAF VTE Prevention VTE treatment Practical

More information

New Anticoagulants for the Treatment of Thromboembolism With a little subplot on superficial thrombophlebitis. Mark Crowther

New Anticoagulants for the Treatment of Thromboembolism With a little subplot on superficial thrombophlebitis. Mark Crowther New Anticoagulants for the Treatment of Thromboembolism With a little subplot on superficial thrombophlebitis Mark Crowther 1 Disclosures Advisory Boards in last 24 months Pfizer, Alexion, Bayer, CSL Behring,

More information

EINSTEIN PE Data Summary & Perspectives on XARELTO (rivaroxaban) in ORS & NVAF. Recorded Webcast Update for Analysts and Investors March 26, 2012

EINSTEIN PE Data Summary & Perspectives on XARELTO (rivaroxaban) in ORS & NVAF. Recorded Webcast Update for Analysts and Investors March 26, 2012 EINSTEIN PE Data Summary & Perspectives on XARELTO (rivaroxaban) in ORS & NVAF Recorded Webcast Update for Analysts and Investors March 26, 2012 1 Webcast Presentation Agenda EINSTEIN PE Clinical Trial

More information

The importance of adherence and persistence: The advantages of once-daily dosing

The importance of adherence and persistence: The advantages of once-daily dosing The importance of adherence and persistence: The advantages of once-daily dosing Craig I. Coleman, PharmD Professor, University of Connecticut School of Pharmacy Storrs, CT, USA Conflicts of interest Dr

More information

Investor News. Not intended for U.S. and UK media

Investor News. Not intended for U.S. and UK media Investor News Not intended for U.S. and UK media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer s Xarelto (Rivaroxaban) Approved for the Treatment of Pulmonary Embolism

More information

New Oral Anticoagulants: Topic Brief

New Oral Anticoagulants: Topic Brief New Oral Anticoagulants: Topic Brief June 9, 2015 High-Level Research Question In patients with nonvalvular atrial fibrillation (AF) or venous thromboembolic disease, or who have undergone surgery for

More information

Management for Deep Vein Thrombosis and New Agents

Management for Deep Vein Thrombosis and New Agents Management for Deep Vein Thrombosis and New Agents Mark Malesker, Pharm.D., FCCP, FCCP, FASHP, BCPS Professor of Pharmacy Practice and Medicine Creighton University 5 th Annual Creighton Cardiovascular

More information

NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM

NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM Carol Lee, Pharm.D., Jessica C. Song, M.A., Pharm.D. INTRODUCTION For many years, warfarin

More information

Prescriber Guide. 20mg. 15mg. Simply Protecting More Patients. Simply Protecting More Patients

Prescriber Guide. 20mg. 15mg. Simply Protecting More Patients. Simply Protecting More Patients Prescriber Guide 20mg Simply Protecting More Patients 15mg Simply Protecting More Patients 1 Dear Doctor, This prescriber guide was produced by Bayer Israel in cooperation with the Ministry of Health as

More information

Use of Antithrombotic Agents In The Presence Of Neuraxial Anesthesia

Use of Antithrombotic Agents In The Presence Of Neuraxial Anesthesia Use of Antithrombotic Agents In The Presence Of Neuraxial Anesthesia Insertion, removal or presence of a catheter in selected sites can place a patient who is antithrombotic agent at risk for a local bleeding

More information

The New Oral Anticoagulants. Yes

The New Oral Anticoagulants. Yes Improving Improving protection protection against against venous venous thromboembolism thromboembolism with new oral anticoagulants with new oral? anticoagulants? The New Oral Anticoagulants will replace

More information

Venous Thromboembolism: Long Term Anticoagulation. Dan Johnson, Pharm.D.

Venous Thromboembolism: Long Term Anticoagulation. Dan Johnson, Pharm.D. Venous Thromboembolism: Long Term Anticoagulation Dan Johnson, Pharm.D. Disclosures No financial relationships with products discussed Off-label use of drug therapy always discussed Objectives Review clinical

More information

The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012

The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012 The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era CCRN State of the Heart 2012 June 2, 2012 Disclosures I have I have been involved in trials of new anticoagulants and have received

More information

Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013

Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Family physician with Rivergrove Medical Clinic Practice in the north end since 1985 Medical Director of the Wellness

More information

New Anticoagulation Agents

New Anticoagulation Agents New Anticoagulation Agents Use of New and Older Therapeutic Agents in the Treatment Regimen Michelle Geddes Case 1 40 year old woman with idiopathic proximal DVT. Previous heparin allergy (wheals, hives)

More information

Rivaroxaban (Xarelto )

Rivaroxaban (Xarelto ) Rivaroxaban (Xarelto ) National Drug Monograph June 2012 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs

More information

Session 3 Topics. Argatroban. Argatroban. Drug Use and Adverse Effects. Laboratory Monitoring of Anticoagulant Therapy

Session 3 Topics. Argatroban. Argatroban. Drug Use and Adverse Effects. Laboratory Monitoring of Anticoagulant Therapy ~~Marshfield Labs Presents~~ Laboratory Monitoring of Anticoagulant Therapy Session 3 of 4 Michael J. Sanfelippo, M.S. Technical Director, Coagulation Services Session 3 Topics Direct Thrombin Inhibitors:

More information

5/21/2012. Perioperative Use Issues. On admission: During hospitalization:

5/21/2012. Perioperative Use Issues. On admission: During hospitalization: Dabigatran and Rivaroxaban: Challenges in the Perioperative Setting Claudia Swenson, Pharm.D., CDE, BC-ADM, FASHP Central Washington Hospital Wenatchee, WA claudia.swenson@cwhs.com Dabigatran and Rivaroxaban:

More information

Trust Guideline for Thromboprophylaxis in Trauma and Orthopaedic Inpatients

Trust Guideline for Thromboprophylaxis in Trauma and Orthopaedic Inpatients A clinical guideline recommended for use In: By: For: Key words: Department of Orthopaedics, NNUHT Medical staff Trauma & Orthopaedic Inpatients Deep vein thrombosis, Thromboprophylaxis, Orthopaedic Surgery

More information

Clinical Use of Rivaroxaban: Pharmacokinetic and Pharmacodynamic Rationale for Dosing Regimens in Different Indications

Clinical Use of Rivaroxaban: Pharmacokinetic and Pharmacodynamic Rationale for Dosing Regimens in Different Indications Drugs (2014) 74:1587 1603 DOI 10.1007/s40265-014-0278-5 REVIEW ARTICLE Clinical Use of Rivaroxaban: Pharmacokinetic and Pharmacodynamic Rationale for Dosing Regimens in Different Indications Toby Trujillo

More information

indications November 2 nd, 2012 Dalhousie University

indications November 2 nd, 2012 Dalhousie University + New oral anticoagulants: A review of current indications November 2 nd, 2012 Dr. Sudeep Shivakumar, Hematology Dalhousie University + Objectives es To review indications for anticoagulation To discuss

More information

The New Kids on the Block: Oral Anticoagulants

The New Kids on the Block: Oral Anticoagulants The New Kids on the Block: Oral Anticoagulants Lauren E. Odum, PharmD, BCPS Clinical Assistant Professor UMKC School of Pharmacy at MU April 11, 2014 Objectives Be able to Understand the major trials leading

More information

This supplement contains the following items:

This supplement contains the following items: This supplement contains the following items: 1. Original protocol (the version of the protocol is unique because it has not been changed). 2. Original statistical analysis plan, final statistical analysis

More information

Clinical practice guideline for the prevention of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to

Clinical practice guideline for the prevention of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to Clinical practice guideline for the prevention of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to Australian hospitals DRAFT FOR PUBLIC CONSULTATION 2009 Commonwealth

More information

Anticoagulation at the end of life. Rhona Maclean Rhona.maclean@sth.nhs.uk

Anticoagulation at the end of life. Rhona Maclean Rhona.maclean@sth.nhs.uk Anticoagulation at the end of life Rhona Maclean Rhona.maclean@sth.nhs.uk Content Anticoagulant Therapies Indications for anticoagulation Venous thromboembolism (VTE) Atrial Fibrillation Mechnical Heart

More information

PERI-OPERATIVE MANAGEMENT OF PATIENTS WHO ARE RECEIVING A NEW ORAL ANTICOAGULANT (DABIGATRAN, RIVAROXABAN,

PERI-OPERATIVE MANAGEMENT OF PATIENTS WHO ARE RECEIVING A NEW ORAL ANTICOAGULANT (DABIGATRAN, RIVAROXABAN, PERI-OPERATIVE MANAGEMENT OF PATIENTS WHO ARE RECEIVING A NEW ORAL ANTICOAGULANT (DABIGATRAN, RIVAROXABAN, APIXABAN) TARGET AUDIENCE: All Canadian health care professionals, including primary care physicians,

More information

Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous thromboembolism in Canada

Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous thromboembolism in Canada 760 Schattauer 2010 Blood Coagulation, Fibrinolysis and Cellular Haemostasis Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous thromboembolism in Canada Alexander

More information

xaban) Policy covered: Coverage of following criteria: the following those who meet the or Hip Xarelto is For those impacted by this policy.

xaban) Policy covered: Coverage of following criteria: the following those who meet the or Hip Xarelto is For those impacted by this policy. Xarelto (rivarox xaban) Policy Number: 5.01.575 Origination: 06/2014 Last Review: 07/2015 Next Review: 07/2016 Policy BCBSKC will provide coverage for Xarelto when it is determined to be medically necessary

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Traditional anticoagulants

Traditional anticoagulants TEGH Family Practice Clinic Day April 4, 03 Use of Anticoagulants in 03: What s New (and What Isn t) Bill Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University

More information