Efficacy in Hip Arthroplasty. Efficacy in Knee Arthroplasty. Adverse Effects. Drug Interactions

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1 Objectives Just for the RECORD: Rivaroxaban joins the US Anticoagulation Arsenal Anne P. Spencer, PharmD, FCCP, BCPS (AQ Cardiology) Cardiovascular Care Pharmacy Specialist Roper Saint Francis Healthcare Roper Hospital, Charleston, SC Describe the evidence-based role of rivaroxaban in anticoagulation therapy Evaluate the safety and efficacy profile of rivaroxaban Compare and contrast rivaroxaban to other oral anticoagulation therapy options Identify possible FDA-approved indications on the horizon Incorporate clinical pearls regarding the use of rivaroxaban into patient-specific care 1 XII XI IX XIIa X XIa IXa PT Xa Fibrinogen Xa inhibitor Rivaroxaban VIIa Thrombin Fibrin + Platelets VII 2 Rivaroxaban (Xarelto ) FDA Approved 7/1/2011 DVT prophylaxis in patients undergoing knee or hip replacement surgery 10 mg once daily (without regard for food at this dose) Begin 6 hours after surgery & hemostasis established Knee: continue for 12 days Hip: continue for 35 days F = %, 92-95% protein bound (1 O albumin) C max occurs in 2-4 hours Metabolism: 50% hepatically metabolized Excretion: ~ 1/3 urine as active drug ~ 1/3 urine as metabolite ~ 1/3 feces (metabolite + active drug) t ½ = 5 9 hours Special Populations Other Details Avoid use in hepatic impairment Moderate (Child-Pugh B) Experienced increased rivaroxaban exposure Severe (Child-Pugh C, excluded from study) Hepatic disease associated with coagulopathy Japanese subjects 50% higher AUC vs other ethnicities (including Chinese) Elderly 50% higher AUC t ½ = hours, age-related decline in renal function < 50 kg and > 120 kg: no influence on exposure OK to crush, but if tube used, must be in stomach to ensure absorption (stomach required for adequate absorption) Antidote not available Use of charcoal to reduce absorption Dialysis not useful highly protein bound Evidence emerging from healthy volunteers that PCC may be effective Circulation DOI: /Circulationaha

2 Rivaroxaban Efficacy Endpoints in Hip and Knee Arthroplasty 1. Death 2. Symptomatic DVT/PE in real-life, the ones that are detected and treated the ones that matter 3. VTE Legs assessed with Dopplers for the presence of VTE Usually asymptomatic Efficacy in Hip Arthroplasty Trial Regimens DVT/PE/ Symptomatic death VTE Record 1 Enoxaparin 40 mg 3.7% 0.5% N = 4541 Qday x 35 days RRR = 70% NS Rivaroxaban 10 mg 1.1% 0.3% Qday x 35 days DVT/PE/ Symptomatic Record 2 Enoxaparin 40 mg 9.3% 1.2% N = 2509 Qday x days RRR = 79% RRR = 80% Rivaroxaban 10 mg 2.0% 0.2% Qday x ~ 35d N Engl J Med 2008;358: Lancet 2008;372:31-9 Efficacy in Knee Arthroplasty Trial Regimens DVT/PE/ Symptomatic Record 3 Enoxaparin 40 mg 18.9% 2.0% N = 2531 Qday x days RRR = 49% RRR = 66% Rivaroxaban 10 mg 9.6% 0.7% Qday x days DVT/PE/ Symptomatic Record 4 Enoxaparin 30 mg 10.1% 1.2% N = 3148 BID x days RRR = 31% NS Rivaroxaban 10 mg 6.9% 0.7% Qday x days N Engl J Med 2008;358: Lancet 2009;373: Adverse Effects Enoxaparin Rivaroxaban Major Bleeding Record 1 0.3% 0.1% NS Record 3 0.5% 0.6% NS Record 4 0.3% 0.7% NS Any Bleeding Record 1 5.9% 6.0% NS Record 3 4.8% 4.9% NS Record 4 9.4% 10.5% NS N Engl J Med 2008;358: N Engl J Med 2008;358: Lancet 2009;373: Efficacy and Safety: Hip and Knee Arthroplasty Rivaroxaban equal to exoxaparin prevention of symptomatic VTE incidence of death bleeding Drug Interactions Rivaroxaban does not appear to affect any other drugs Several drugs affect rivaroxaban Substrate of CYP3A4/5 CYP2J2 P-glycoprotein (P-gp) transporter (ABCB1) ATP-binding cassette G2 transporter(abcg2) 2

3 Avoid Rivaroxaban Severe impairment of a major elimination pathway CrCl < 30 ml/min Strong 3A4 and p-glycoprotein inhibitor AUC increase 150% Ketoconazole, itraconazole, lopinovir, ritonavir, indinivir, conivaptan Rivaroxaban OK Moderate P-glycoprotein and 3A4 inhibitors Clarithromycin, erythromycin Only minor AUC increases observed Caution with Rivaroxaban: benefits >> risks 2 small strikes at elimination pathways Renal impairment (ClCr ml/min) AND P-gp and weak/moderate CYP 3A4 inhibitors Erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine Avoid or Increase dose P-gp inducer + strong CYP3A4 inducer 50% decrease in AUC Increase dose to 20 mg (take w food) Rifampicin, carbamazepine, phenytoin, rifampin, st. John s wort Anticoagulants for VTE prevention after arthroplasty LMWH Warfarin Dabigatran Rivaroxaban Cost $440 $ 15 $ 40 $ 60 Route SQ PO PO PO Onset hours days hours hours Drug zero extensive 1(rare) many Interactions Adverse none none GI upset none Effects SCIP-VTE yes yes w/ hoop w/ hoop Measure jumping jumping compliant?* *as of August 10, 2011 Future Indications? Atrial fibrillation Dabigatran: FDA approved Rivaroxaban FDA committee recommends Yes September 2011 FDA to review in November 2011 DVT/PE treatment Dabigatran:RE-COVER trial Not under review at FDA for this indication Rivaroxaban: EINSTEIN trial Not under review at FDA for this indication EMA committee recommends Yes September 2011 EMA to review by December

4 Future Indications? Acute Coronary Syndromes Data reportedly positive for rivaroxaban via press release ATLAS-ACS 2, TIMI 51 decreased events, but increased bleeding May be presented in November 2011 AHA meeting Data for apixaban in ACS was overall negative Decreased cardiovascular events Increased bleeding Rivaroxaban in Atrial Fibrillation ROCKET AF trial N = 14,264 (double-blind, randomized, 45 countries) Warfarin (INR 2 3) Rivaroxaban 20 mg QDay or 15mg QDay ClCr ml/min None-inferiority trial Primary endpoint: Stroke or systemic embolism Moderate/high risk of stroke CHADS 2 score 2 (0-6 point scale) CHF, HTN, age > 75, DM, stroke/tia Rivaroxaban in Atrial Fibrillation Results Duration of treatment: median 1.6 years Drop-outs: 23.7% and 22.2% Warfarin Rivaroxaban Age Female 40% 40% CHADS % 13% 3 44% 43% 4 28% 29% 5 12% 13% 6 2% 2% Results Stroke or Systemic Embolism (PPY) Overall ITT Warfarin Rivaroxaban stat. interpr. Stroke/embolism 2.4% 2.1% non-inferior During Treatment 2.2% 1.7% superior Following 43% 4.3% 47% 4.7% NS discontinuation (~ 23% of population) Clinically relevant 14.5% 14.9% NS Bleeding Major Bleeding 3.4% 3.6% NS How did the 15mg dose perform? 1. Renal Dysfunction 15 mg dose (ClCr ml/min) 21% of the population Warfarin 2.77% vs Rivaroxaban 2.38% P = NS FDA Draft Briefing Document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Meeting Date: 8 September 2011,NDA: FDA Concerns 1. New therapy must be as effective as an approved therapy when the approvedtherapy drug is used skillfully Warfarin was not used as skillfully in ROCKET as in RE-LY (dabigatran) and other recent trials, thereby making it difficult to assess the true efficacy of rivaroxaban. Warfarin Time-in-Therapeutic Range (TTR) RELY (dabigatran) 67% ARISTOTLE (apixaban) 66% Many anticoagulation centers ~ 70% ROCKET AF (rivaroxaban) 58% 4

5 FDA Concerns 2. Because of a high number of events observed in patients when they discontinued use of rivaroxaban, there is no firm guidance for how to transition patients to warfarin or other drugs when rivaroxaban is discontinued. Upon study end, rivaroxaban was discontinued, and warfarin initiatiaed (without bridging ) In first 30 days Rivaroxaban warfarin = 22 strokes/embolic events Warfarin warfarin = 6 strokes/embolic events FDA Concerns 3. The optimal dose of rivaroxaban is still unclear. Many on the committee thought rivaroxaban might perform better as a twice-a-day drug. Big Issues for Hospitals Reversibility What to do if patient comes in bleeding or needs emergency surgery SCIP-VTE Core Measure Currently, only LMWH and warfarin are automatically acceptable Documentation currently required if this agent used for VTE prophylaxis in place of acceptable agents TJC National Patient Safety Goal Reduce the likelihood of patient harm associated with the use of anticoagulant therapy TJC: Elements of Performance Evidence of a written policy that addresses baseline and ongoing tests required for anticoagulation. Provide education regarding anticoagulation therapy to prescribers, staff, patients, and families. Evaluate anticoagulation safety practices. Issues for Everybody Take with food? Only sometimes?? Linear and high bioavailability up to 15 mg The ROCKET AF study (20 mg/day) gave each dose with food to ensure adequate absorption Low albumin (or highly hl protein bound drug) Japanese ethnicity Elderly (moderate renal dysfunction) and increased exposure Especially if used for long-term Drug Interactions Summary Rivaroxaban 10 mg Qday is as effective as standard therapy for the prevention of VTE following arthroplasty (hip or knee) No significant adverse effects outside of bleeding Drug interactions must be managed ClCr > 30 ml/min required FDA to address atrial fibrillation indication in Fall 2011 Apixiban may be submitted to FDA year end 2011 Atrial fibrillation (ARISTOTLE, N Engl J Med 2011;365:981-92) 5

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