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1 Rivaroxaban Mohamed El Setiha, MD. Prof of Cardiology Tanta University

2 Antithrombotics That Have Changed Clinical Practice Anticoagulants Low-molecular-weight l heparin Antiplatelet Drugs Thienopyridines Glycoprotein IIb/IIIa Inhibitors

3 But.. for oral anticoagulation, Vitamin K antagonists (warfarin) remain the only available option

4 The ideal oral anticoagulant Oral, preferably once daily Rapid onset and offset of action Low propensity for food and drug interactions Fixed doses Wide therapeutic window Easy to use with no need for monitoring i Have antidote

5 Rivaroxaban in VTE

6 Phase III RECORD programme in VTE prevention Oral rivaroxaban 10 mg od is being compared with subcutaneous enoxaparin in >11,000 patients worldwide Study RECORD1 THR Duration of rivaroxaban therapy Duration of enoxaparin therapy 5 weeks 5 weeks RECORD2 THR 5 weeks days, followed by placebo RECORD3 TKR days days RECORD4 TKR days days

7 Primary Efficacy endpoints Total venous thromboembolism (VTE): any deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE), and all-cause mortality Secondary Major VTE: proximal DVT, non-fatal PE, and VTE-related death DVT: any, proximal, distal Symptomatic VTE All endpoints were adjudicated centrally by independent, blinded committees

8 Safety endpoints Main Major bleeding starting after the first blinded dose and 2 days after last dose Bleeding that was fatal, into a critical organ or required re-operation Extra-surgical-site site bleeding associated with a drop in hemoglobin 2 g/dl or requiring transfusion of 2 units blood Other Any bleeding on treatment* Non-major bleeding* Hemorrhagic wound complications* Cardiovascular adverse events Liver enzyme levels All endpoints were adjudicated centrally by independent, blinded committees *Up to 2 days after last dose of study medication

9 Oral rivaroxaban compared with subcutaneous enoxaparin for extended thromboprophylaxis after total hip arthroplasty

10 RECORD1 study design Double blind R S Rivaroxaban 10 mg od U R 6 8 hours post-surgery G E 6 8 hours post-surgery R Y Enoxaparin 40 mg od Evening before surgery Mandatory bilateral venography Day 1 Day 36±4 F O L L O W U P Up to Day 65 Last dose, day before venography Inclusion criteria Patients aged 18 years, scheduled to undergo elective THR Major exclusion criteria Active bleeding or high risk of bleeding Significant liver disease Anticoagulant therapy that could not be stopped Use of HIV-protease inhibitors

11 5 RECORD1: summary Rivaroxaban 10 mg once daily Total VTE Enoxaparin 40 mg once daily 4 RRR 70% dence (%) Inci 3 2 Major VTE RRR 88% % 1.1% 2.0% 0.2% Symptomatic VTE Major bleeding 0.5% 0.3% 0.1% 0.3%

12 Extended d thromboprophylaxis h with rivaroxaban compared with short-term thromboprophylaxis with low molecular l weight heparin after total hip arthroplasty

13 RECORD2: study design Double blind R S U R G E R Y Rivaroxaban 10 mg od 6 8 hours post-surgery 6 8 hours post-surgery Evening before surgery Enoxaparin 40 mg od Day 1 Oral placebo Mandatory bilateral venography Day 36±4 F O LL O W U P Day 65+5 Inclusion criteria Patients aged 18 years, scheduled to undergo elective THR Major exclusion criteria Active bleeding or high risk of bleeding Significant liver disease Anticoagulant therapy that could not be stopped Use of HIV-protease inhibitors

14 RECORD2: summary 10 8 Total VTE Rivaroxaban 10 mg once daily Enoxaparin 40 mg once daily nce (%) Incide RRR 78.9% Major VTE RRR 87.8% Symptomatic VTE Major bleeding RRR 80.1% 9.3% 2.0% 5.1% 0.6% 1.2% 0.2% 0.1% 0.1%

15 Rivaroxaban an oral direct Factor Xa inhibitor Rivaroxaban an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in total knee arthroplasty surgery

16 RECORD3: study design Double blind R S U R G E R Y Rivaroxaban 10 mg od 6 8 hours post-surgery 6 8 hours post-surgery Enoxaparin 40 mg od Mandatory bilateral venography Evening before surgery Day 1 Day 13±2 Last dose, 1 day before venography F O LL O W U P Day 42+5 Inclusion criteria Patients aged 18 years, scheduled to undergo elective, total knee replacement (TKR) surgery Major exclusion criteria Active bleeding or high risk of bleeding Significant liver disease Anticoagulant therapy that could not be stopped Use of HIV-protease inhibitors

17 RECORD3: summary Total VTE RRR 49% Enoxaparin 40 mg od Rivaroxaban 10 mg od Incidenc ce (%) 10 Major VTE Symptomatic VTE 5 Major bleeding RRR 62% RRR 65% NS 18.9% 9.6% 2.6% 1.0% 2.0% 0.7% 0.5% 0.6% 0

18 Rivaroxaban in ACS ATLAS TIMI 46 ATLAS TIMI 51

19 %) eeding (% ificant Ble Clinic cally Sign PRIMARY SAFETY ENDPOINT: CLINICALLY SIGNIFICANT BLEEDING Total Daily Dose: (= TIMI Major, TIMI Minor, Bleed Req. Med. Attn.) Rivaroxaban 20 mg ---- Rivaroxaban 15 mg ---- Rivaroxaban 10 mg ---- Rivaroxaban 5 mg ---- Placebo % 12.7% HR 5.1 ( ) 3.6 ( ) % 3.4 ( ) Days After Start of Treatment Kaplan-Meier estimates for cumulative events, HR(CI), for bleeding rates during the 180 day period ; HR=Hazard Ratio; CI=Confidence Interval 61% 6.1% 3.3% ( ) *p<0.01 for placebo Vs Riva 5mg. p<0.001 for Riva 10,15,20mg 15 vs placebo Gibson CM, AHA 2008

20 Ra te (%) SAFETY ENDPOINTS: TIMI Major, TIMI Minor and Bleeding Req. Med. Attn. ASA Alone P trend< Plac Plac Plac TIMI Major TIMI Minor Med Attention P trend< ate (%) Ra Plac Plac Plac TIMI Major TIMI Minor Med Attention Raw Event rates for TIMI Major & TIMI Minor in ASA Alone & ASA+CLOP arm. Raw event rates for Med Attention in ASA alone. Kaplan-Meier estimate bleeding rate for medical attention in ASA+CLOP arm during 180 day period. P trend=p value for dose response over actual dose values. Gibson CM, AHA 2008

21 evasc. (%) emia Req. Re Severe Ische Death / MI / Stroke / PRIMARY EFFICACY ENDPOINT: Death / MI / Stroke / Severe Ischemia Req. Revascularization All Placebo (n = 1160) 7.0% All Rivaroxaban (n = 2331) Days After Randomization Cumulative Kaplan-Meier estimates of HR and the rates of key study end points during the 180 day period; Death=All Cause Death ; HR=Hazard Ratio; MI=Myocardial Infarction; 5.6% HR 0.79 ( ) p = 0.10 Gibson CM, AHA 2008

22 oke (%) h / MI / Stro Death SECONDARY EFFICACY ENDPOINT: Incidence of Death / MI / Stroke Stratum 1: ASA Alone Stratum 2: ASA + Clop HR P trend = 0.01 P trend = 0.72 oke (%) * 3.8 HR HR HR O.71 h / MI / Stro HR Death HR 1.24 HR TDD n=253 n=154 n=196 n=158 n=907 n=154 n=860 n=356 n=453 * Kaplan-Meier estimates for cumulative events, HR, for rates of key study end points during the 180 day period; P trend=p value for dose response over actual dose values Death=All Cause Death; HR=Hazard Ratio; MI=Myocardial Infarction. Note change in axis right hand panel. Death=All Cause Death; HR=Hazard Ratio; MI=Myocardial Infarction. Note change in axis right hand panel. Gibson CM, AHA 2008

23 Posted on November 1, 2008 VASCULAR MEDICINE/INTERVENTION ATLAS TIMI 46: Rivaroxaban did not lower endpoint of death, MI, stroke, severe ischemia requiring revascularization with more bleeding.

24 Rivaroxaban in AF

25 ROCKET AF ROCKET AF study (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF study is assessing the efficacy and safety of rivaroxaban (Xarelto ) 20 mg once-daily, a novel oral, direct Factor Xa inhibitor, compared to the current standard of care, warfarin, a vitamin K antagonist (VKA) dose-adjusted, for the prevention of stroke and non-cns systemic embolism in patients with Atrial Fibrillation (AF).

26 Side Effects bleeding or oozing from the surgical wound signs of bleeding (e.g., bloody nose that lasts for more than 5 minutes, blood in urine, coughing blood, cuts that don't stop bleeding, gums that bleed for longer than 5 minutes when brushing teeth, bleeding into the rectum or from hemorrhoids, excessive menstrual bleeding) signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools) stiff, sore, hot, or painful joints symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling) unexpected bruising or bleeding after surgery

27 Drug Interaction acetylsalicylic acid amiodarone azole antifungal medications (e.g., ketoconazole, itraconazole, voriconazole) carbamazepine carvedilol certain anti-hiv medications (e.g., ritonavir, lopinavir, saquinavir, a tenofovir clarithromycin clopidogrel corticosteroids (e.g., hydrocortisone, methylprednisone, prednisone) cyclosporine dalteparin dipyridamole enoxaparin fondaparinux grapefruit juice

28 Drug Interaction heparin nefazodone nicardipine nonsteroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen) phenobarbital phenytoin rifampicin SSRIs (e.g., citalopram, escitalopram, fluoxetine, paroxetine) St. John's wort sulfinpyrazone tacrolimus tamoxifen ticlopidine verapamil warfarin

29 Other Side Effects Convulsion, hemiplegia, hypoasthesia. Pneumonia and hemoptysis, pleural effusion. Hypovolemic shock Acute renal failure. MI

30 Contra-indications Rivaroxaban should not be taken by anyone who: is allergic to rivaroxaban or to any of the ingredients of the medication is bleeding excessively is pregnant or breast-feeding is taking certain medications such as ketoconazole, itraconazole, voriconazole, posaconazole, or ritonavir has a body lesion at risk of bleeding, including bleeding in the brain within the last 6 months has liver disease associated with an increased risk of bleeding

31

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