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Comparison of Warfarin Pradaxa and Xarelto

Comparison of Warfarin Pradaxa and Xarelto

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PL Detail-Document #271001

−This PL Detail-Document gives subscribers additional insight related to the Recommendations published in−

PHARMACIST’S LETTER / PRESCRIBER’S LETTER
October 2011

Comparison of Oral Antithrombotics
(Last modified November 2011) The recent proliferation of oral anticoagulants and antiplatelet agents has health care professionals questioning how to choose among them. The newest anticoagulants are dabigatran (Pradaxa, Pradax [Canada]) and rivaroxaban (Xarelto). Also look for the direct factor Xa inhibitor apixaban possibly in 2012, and edoxaban and betrixaban in the next few years. The following chart compares the indications, clinical benefit, antidotes, washout, and other therapeutic considerations for these agents. Abbreviations: ACS = acute coronary syndrome; ADP = adenosine diphosphate; A fib = atrial fibrillation; AV = arteriovenous; AWP = average wholesale price; BID = twice daily; CAD = coronary artery disease; DVT = deep vein thrombosis; LMWH = low molecular weight heparin; LVD = left ventricular dysfunction; MI = myocardial infarction; PE= pulmonary embolism; STEMI = ST segment elevation myocardial infarction; TIA = transient ischemic attack; VTE = venous thromboembolism Drug: Mechanism Approved Indications Clinical Benefit In…c Antidote/ Therapeutic b (Usual Maintenance Dose) pre-op, preConsiderations Cost of 30-day procedure supplya washout (if indicated) ANTICOAGULANTS (see information about the investigational drug apixaban at the end of the chart) Dabigatran U.S.:5 A fib: prevents about five more No specific  Requires BID dosing for (Pradaxa; Pradax strokes per 1000 patients per year antidote  Thromboembolism (e.g., stroke) A fib.5,6 5 [Canada]): than warfarin. Lower rate of prevention in A fib (150 mg BID)  Dispense/store in original direct thrombin hemorrhagic stroke, higher rate of See our PL container. Once opened, inhibitor5,6 major GI bleed7 DetailCanada:6 discard after four months Document,  Thromboembolism (e.g., stroke) (U.S.) or 30 days (150 mg BID) Post-hip/knee replacement (off-label Reversing prevention in A fib (150 mg BID, (Canada).5,6 U.S.: $262.44 [U.S.]): comparable to enoxaparin for Dabigatran 110 mg BID for patients over 80 yrs).  To switch from warfarin, (AWP) prevention of VTE & mortality and  VTE prevention post-hip or knee stop warfarin, then start (combined endpoint); comparable Rivaroxaban replacement (220 mg once daily x 10 dabigatran when INR <2.5,6 8-10 Canada: $103.68 major bleeding days [knee] or 28 to 35 days [hip]. If See product labeling for started 1-4 hrs post-op, initial dose is instructions for switching VTE treatment (off-label): 110 mg) to warfarin, or to/from comparable to warfarin for prevention injectable anticoagulants. of recurrent VTE or VTE death  Check renal function at Continued… (combined endpoint); comparable baseline, and yearly in
More. . .
Copyright © 2011 by Therapeutic Research Center P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com ~ www.pharmacytechniciansletter.com

dronedarone. poor renal function.prescribersletter..6 Continued… Copyright © 2011 by Therapeutic Research Center P. Canada).com  P-glycoprotein inhibitors (e.5 VTE.g. then 150 mg once daily if CrCl 30 to 50 mL/min.6.5. verapamil.6 Strong pMore. quinidine. contraindicated if CrCl < 30 mL/min. Dabigatran dose adjustment may be needed (see labeling). amiodarone) can increase dabigatran levels.5. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. use 75 mg BID if CrCl 15 to 30 mL/min. preprocedure washout (if indicated) Therapeutic Considerations major bleeding11 patients over 75 years or with CrCl < 50 mL/min.7  Caution if 75 years & over (over 75 years.).(PL Detail-Document #271001: Page 2 of 14) Drug: Mechanism Cost of 30-day supplya Dabigatran.S. ketoconazole. .5  Renal dosing: A fib (U. . Stockton. Box 8190. or underweight. .pharmacistsletter.com ~ www.43  Co-administration with aspirin or clopidogrel about doubles bleeding risk. use 75 mg x 1.pharmacytechniciansletter.6  Causes dyspepsia in over 10% of patients.O.com ~ www.6 Canada. continued Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.

Pglycoprotein inducers (e.: $262.prescribersletter. John’s wort.pharmacytechniciansletter. not hypercoagulability.O. itraconazole. Lower rate of hemorrhagic stroke...12 More.S. No specific antidote See our PL DetailDocument. ritonavir [all contraindicated.5  Once daily dosing. per Canadian labelling]. assuming hemostasis achieved)  Thromboembolism (e.S. ketoconazole. labeling. Reversing Dabigatran and Rivaroxaban Canada:13  VTE prevention post-hip or knee replacement (10 mg once daily for 35 days [hip] or 14 days [knee]. St.6 Avoid per U.g.pharmacistsletter.. John’s wort) may decrease efficacy.12. continued Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.18 For A fib.06 U. rifampin. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. phenytoin. but BID dosing untested. Box 8190. stroke) prevention in A fib (20 mg once daily with evening meal to improve absorption) Post-hip/knee replacement: at least as effective as enoxaparin for prevention of VTE or mortality (combined endpoint).S. conivaptan). tenofovir) could decrease dabigatran efficacy. comparable major bleeding14-17 A fib (off-label [Canada]): comparable to warfarin for preventing stroke or systemic embolism in patients with relatively high stroke risk. Copyright © 2011 by Therapeutic Research Center P. assuming hemostasis achieved) Continued… glycoprotein inhibitors (e.66  Avoid use with drugs that are BOTH pglycoprotein and strong CYP3A4 inhibitors (e. ketoconazole) contraindicated per Canadian labeling. but INR in therapeutic range only 55% of time. Comparable major bleeding. Stockton. 15.g. posiconazole. clarithromycin.g. carbamazepine.13 (10.g.S. or 20 mg once daily) U. labeling. carbamazepine..18 DVT treatment (off-label): comparable to enoxaparin/warfarin for prevention of recurrent VTE. voriconazole. preprocedure washout (if indicated) Therapeutic Considerations Rivaroxaban (Xarelto): direct factor Xa inhibitor12.12. rifampin.44 (AWP) (10 mg once daily) Canada: $287. some data suggest once daily dosing insufficient. Increase in events after stopping may reflect poor transition to warfarin.(PL Detail-Document #271001: Page 3 of 14) Drug: Mechanism Cost of 30-day supplya Dabigatran.13 Avoid per U. starting 6-10 hrs post-op.13.com ~ www.com ~ www.:12  VTE prevention post-hip or knee replacement (10 mg once daily for 35 days [hip] or 12 days [knee] starting 610 hrs post-op.. St.6 Pglycoprotein inducers (e.com . . higher rate of major GI bleed. .g.

(PL Detail-Document #271001: Page 4 of 14) Drug: Mechanism Cost of 30-day supplya Rivaroxaban.13  Avoid use with other anticoagulants. and mortality (INR 2.pharmacytechniciansletter. Copyright © 2011 by Therapeutic Research Center P. .41  Gold standard oral anticoagulant.21.8 to 4.:20  Prevention/treatment of venous thrombosis/PE  Prevention/treatment of thromboembolism due to A fib or prosthetic heart valve  Secondary prevention post-MI Canada:21  Prevention/treatment of venous thrombosis/PE  Prevention/treatment of thromboembolism due to A fib A fib: prevents stroke (NNT = 32 vs placebo for one year to prevent one stroke)22 PE/DVT (with initial use of heparin): reduces risk of recurrence and mortality [Evidence level B. avoid if CrCl < 30 mL/min.43 Continued… U.24 Warfarin (Coumadin. continued Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.  INR monitoring required at least every four weeks. lower quality RCTs]23 Post-MI: reduces reinfarction.S. generics): inhibits formation of vitamin-K dependent clotting factors20.S.12.12 Antiplatelets may increase bleeding risk.13 Vitamin K/ Washout: five days20.21 (5 mg once daily) U.5) plus aspirin (75 mg once daily) superior to aspirin alone or warfarin (INR 2.com ~ www.com ~ www.13  A fib indication requires renal dosing (15 mg with evening meal for CrCl 15 to 50 mL/min).12 For VTE prevention.21  Many drug and food interactions. long-term. over 50 years’ experience.com . Box 8190. coadminister with caution.).12.  For VTE. . CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. stroke.: $6.65 Canada: $3. Stockton.S.8 to 4. monitor during transition periods. monitor if CrCl close to 30 mL/min.O.2) More. preprocedure washout (if indicated) Therapeutic Considerations comparable bleeding19  Check renal function periodically (U.prescribersletter. benefit may not outweigh risk in patients with high bleeding risk.pharmacistsletter.8).25 warfarin (INR 2 to 2.20.12 Canada.

(PL Detail-Document #271001: Page 5 of 14) Drug: Mechanism Cost of 30-day supplya Warfarin.O. Stockton. TIA. or unstable angina.65  For primary prevention of cardiovascular disease. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. Canada): reduces embolism and valve thrombosis (mostly based on nonrandomized. Copyright © 2011 by Therapeutic Research Center P. reduces embolic events in patients with A fib. or new stroke despite INR in therapeutic range. stroke) postMI (adjunct)  TIA (adjunct) (Note: warfarin dosing variable and patient specific. But combo may benefit certain high-risk mechanical heart valve patients. reserve aspirin for certain high-risk patients (See PL Detail-Document. 2C19.prescribersletter. (vascular indications):33 cyclo-oxygenase  Secondary prevention after ischemic stroke.39  Potential for significant interactions with inducers/inhibitors of CYP2C9. preprocedure washout (if indicated) Therapeutic Considerations  Prevention of reinfarction and thromboembolism (e. Benefit may also outweigh risk in A fib or VTE history plus recent stent.42. 1A2. MI. and stroke27 Acute MI: reduces vascular mortality33 Chronic stable angina (off-label. Box 8190. Canada): reduces risk of MI or More. U.com ~ www.) alone (combined endpoint)26 Rheumatic mitral valve disease (offlabel): reduces embolic events and mortality in patients with embolic history.com . Aspirin for Primary Prevention).28  Use with aspirin increases bleeding risk.S.34 ANTIPLATELETS Aspirin: inhibits U.pharmacistsletter. recent CABG. uncontrolled case series)32  Not more effective than aspirin for noncardioembolic stroke.pharmacytechniciansletter. continued Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.S.S. . . promotes resolution of left atrial thrombus [Evidence level B. (81 mg once daily) (81 to 325 mg daily) U. clinical cohort]29-31 Mechanical heart valve (off-label. ischemic stroke in high-risk women34 Post-ACS: reduces risk of mortality. re-infarction..g. Platelet transfusion38/ Washout: five to 10 days35  In A fib patients with no stroke risk factors.): reduces MI in men.com ~ www. aspirin 81 to 325 mg daily recommended instead of anticoagulation.: <$1  Acute MI (81 to 325 mg daily)  Chronic stable angina (81 to 325 mg Canada: <$1 daily)  Revascularization procedures (81 to 325 mg daily) Canada (vascular indications):44 Continued… Primary CV event prevention (offlabel. and 3A4.

pharmacistsletter.O.S. Then as for secondary prevention)  Prevention of VTE post-hip replacement (650 mg BID) (note: current guidelines recommend against aspirin monotherapy for VTE prophylaxis)45  Reduction of platelet adhesiveness in hemodialysis patients with silicone rubber AV cannula (dose not specified)  Post-carotid endarterectomy (dose not specified) U.32 Continued…  Secondary prevention after MI or unstable angina (81 to 325 mg once daily)  Primary prevention of MI in highrisk patients (81 to 325 mg once daily)  To reduce risk of TIA or recurrent stroke (81 to 325 mg once daily)  Acute MI (160 mg immediately. No increase in bleeding risk vs aspirin alone noted in patients receiving concomitant cilostazol plus aspirin in clinical trials (n=201). [Evidence level B.prescribersletter. clinical cohort study]. or stroke (combined endpoints)64 Post-coronary stent (off-label): prevents stent thrombosis40 A fib (off-label): Efficacy inferior to warfarin and not much better than no treatment at all in “real world” use. dual antiplatelet therapy is initially indicated. or vascular death. preprocedure washout (if indicated) Therapeutic Considerations Cilostazol (Pletal.com . Copyright © 2011 by Therapeutic Research Center P.S. then daily for 30 days. Benefit may also outweigh risk in A fib or VTE history plus recent stent. recent CABG.(PL Detail-Document #271001: Page 6 of 14) Drug: Mechanism Cost of 30-day supplya Aspirin.:53  Intermittent claudication (100 mg BID) sudden death. But combo may benefit certain high-risk mechanical heart valve patients. . continued Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op. MI.S. or serious vascular events (combined endpoints)47 TIA or minor noncardioembolic stroke: reduces risk of stroke or death. only]): inhibits platelet phosphodiesterase III54 (100 mg BID) U. generics [U.com ~ www.: $24. But long-term More. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.67  Post-coronary stent.com ~ www.39 Intermittent claudication: increases walking distance53 No specific antidote/ Washout: two to three days41  Use with aspirin enhances platelet inhibition vs aspirin alone. or new stroke despite INR in therapeutic range. Stockton. .40  Use with warfarin increases bleeding risk.pharmacytechniciansletter. Box 8190.

52  Efficacy affected by CYP2C19 inhibitors and pharmacogenetics. or with peripheral artery disease) (75 mg once daily)  ACS (300 mg loading dose.com .. stroke.O. MI.66 Canada: $85.com ~ www.37/ Washout: five to seven days35 safety with aspirin unknown.: $188.37 (75 mg once daily) U. STEMI.46 But combo not as effective as warfarin.27. can skip loading dose in STEMI)  Thromboembolism (e. nonSTEMI.S. and not safer.37 Peripheral artery disease: reduces risk of stroke.36. then 75 mg once daily. MI.37. stroke). plus aspirin 81 to 325 mg daily.:36  ACS (300 mg load.(PL Detail-Document #271001: Page 7 of 14) Drug: Mechanism Cost of 30-day supplya Cilostazol.54 More.pharmacytechniciansletter. can skip loading dose in STEMI)  Recent stroke (75 mg once daily)  Recent MI (75 mg once daily)  Peripheral artery disease (75 mg once daily) Canada:37  Secondary prevention in patient with atherosclerosis (i. and/or stroke (combined endpoint)36. or vascular death (combined endpoint)28.37. or vascular death (combined endpoint)36. or vascular death (combined endpoint)36.S. preprocedure washout (if indicated) Therapeutic Considerations Clopidogrel (Plavix): blocks platelet ADP P2Y12 receptor36. Box 8190. or refractory ischemia (combined endpoint)36.): reduces risk of stroke. MI. stroke) prevention in A fib (75 mg once daily plus aspirin 81 mg once daily) Non-STEMI (with aspirin): reduces cardiovascular death. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. Stockton. and post-stent.e. re-infarction.37 Recent noncardioembolic stroke (offlabel.prescribersletter.37 A fib (with aspirin): reduces vascular events (e.S.37 Recent MI: reduces risk of stroke. .g. .68  Clopidogrel may be superior to aspirin for secondary prevention of stroke post-stroke/TIA. symptomatic CAD. then 75 mg once daily.g.. U. MI.53  CYP3A4 and CYP2C19 interactions.37 STEMI (with aspirin): reduces risk of death or death. Copyright © 2011 by Therapeutic Research Center P.46.com ~ www.53  Used with aspirin in A fib (not first-line).22 U. patients with a history of stroke or MI. continued Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.68 Platelet transfusion suggested36.. plus aspirin 81 to 325 mg once daily.pharmacistsletter.

51 (One capsule BID) U. Stockton. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacytechniciansletter.50.32 Canada: $53. superior to placebo or monotherapy with aspirin or dipyridamole extended-release50. preprocedure washout (if indicated) No specific antidote/ Washout: two to three days41 Therapeutic Considerations  Four times daily dosing.52  Drug of choice for secondary prevention of stroke post-stroke/TIA.com ~ www.:48  Prevention of thromboembolism post-heart valve replacement.S.prescribersletter.48. Copyright © 2011 by Therapeutic Research Center P.99 Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c U.51 No specific antidote/ Washout: five to 10 days (see aspirin)  BID dosing.pharmacistsletter.S.5% per year in case series32 Antidote/ pre-op.49  Despite indication.: $88. generics): inhibits platelet adenosine uptake48.49 (75 mg four times daily) U.51  Not substitutable with dipyridamole plus aspirin separately. data insufficient to recommend for valvular heart disease.33 U.S.:50  Secondary prevention of stroke poststroke/TIA (one capsule BID) Canada:51  Secondary prevention of stroke in patients who have had a stroke or TIA (one capsule BID) Secondary prevention of stroke: reduces stroke risk.com .52 More.79 Canada: $56.O.: $215.S. . Box 8190.(PL Detail-Document #271001: Page 8 of 14) Drug: Mechanism Cost of 30-day supplya Dipyridamole (Persantine. with warfarin (75 to 100 mg four times daily) Canada:49  Prevention of thromboembolism post-heart valve replacement (100 mg four times daily) Mechanical heart valve (with warfarin or warfarin plus aspirin): thromboembolic rates 0.6 to 1.com ~ www.32 Dipyridamole extended release 200 mg/aspirin 25 mg (Aggrenox): inhibits cyclooxygenase & platelet adenosine uptake50. .

18 Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c U.57 Co-administer with caution.68 Canada: $86.58.57  Efficacy not affected by pharmacokinetics or CYP450 inhibitors. and/or who have had a cardiac event while taking clopidogrel.57  Consider for patients with low bleeding risk and high cardiovascular event risk.: $202.58.S. and stroke (combined endpoint) by 2% vs clopidogrel plus aspirin.60  Reversible binding to platelet receptor. then 10 mg once daily with aspirin 81 to 325 mg once daily) ACS managed with PCI (with aspirin): reduces cardiovascular death. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.:56  ACS managed with PCI (including stenting). then 10 mg once daily with aspirin 81 to 325 mg once daily) Canada:57  ACS managed with PCI (including stenting). with aspirin 81 mg) Canada:60  ACS (180 mg loading dose.58  Adverse effects of note include bradycardia.56.com .56.:58  ACS (180 mg loading dose. Stockton.S.57  Contraindicated in stroke/TIA history. MI.56.57  BID dosing.  Use with warfarin increases bleeding risk. Copyright © 2011 by Therapeutic Research Center P.prescribersletter.56.S. dyspnea. or stroke (combined endpoint) and stent thrombosis vs clopidogrel (with aspirin)59 Aminocaproic acid or tranexamic acid and/or recombinant factor VIIa suggested60/  Consider dose reduction in patients <60 kg. .com ~ www. then 90 mg twice daily.(PL Detail-Document #271001: Page 9 of 14) Drug: Mechanism Cost of 30-day supplya Prasugrel (Effient): blocks platelet ADP P2Y12 receptor57 (10 mg once daily) U. higher bleeding risk55 Antidote/ pre-op. and gynecomastia in men.56  Not recommended in patients 75 or older. MI. Box 8190. preprocedure washout (if indicated) Platelet transfusion suggested56/ Washout: seven days35 Therapeutic Considerations Ticagrelor (Brilinta): blocks platelet ADP P2Y12 receptor58 Continued… U. with aspirin 81 mg) ACS (with aspirin): reduces risk of cardiovascular death.pharmacytechniciansletter.O. with aspirin (60 mg loading dose. with aspirin (60 mg loading dose.59 More. and for patients with reduced CYP2C19 activity due to a genetic variation or interacting medication.com ~ www. then 90 mg twice daily. .pharmacistsletter.

Higher doses of aspirin reduce efficacy of ticagrelor.68 Canada: $32.57 U.O.52  BID dosing.: $260. minor stroke. preprocedure washout (if indicated) Washout: five days58. MI.60 Therapeutic Considerations Ticlopidine (generic only): blocks platelet ADP P2Y12 receptor (250 mg BID) U.com . .S.61 Coadminister only with close monitoring.S. Stockton.: $111. Copyright © 2011 by Therapeutic Research Center P. and vascular death (combined endpoint)28 Post-coronary stent (with aspirin): Better than aspirin alone or warfarin for preventing death.  Adverse effects of note include neutropenia.28.78 Canada: $95.com ~ www.63  Maintenance aspirin dose 81 mg.60  Not a first-line agent. . thrombotic thrombocytopenic purpura. or transient monocular blindness (TMB) (250 mg BID) Post-TIA/noncardioembolic stroke: reduces risk of stroke.pharmacytechniciansletter.  CYP3A4 interactions.90 Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.63 More.:61  Secondary prevention of stroke poststroke/TIA (250 mg BID)  Prevention of stent thrombosis (250 mg BID with low-dose aspirin) Canada:63  Prevention of first or recurrent stroke in patients with a history of thromboembolic stroke. and rash. revascularization.(PL Detail-Document #271001: Page 10 of 14) Drug: Mechanism Cost of 30-day supplya Ticagrelor. reversible ischemic neurological deficit (RIND).pharmacistsletter.prescribersletter.58. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. TIA.58  Consider for patients who have had a cardiac event while taking clopidogrel. and for patients with reduced CYP2C19 activity due to a genetic variation or interacting medication.S. diarrhea.60  Not studied with oral anticoagulants.28  Long-term safety with anticoagulants not established. Coadminister with caution. continued (90 mg BID) U. Box 8190.com ~ www. thrombosis. or MI (combined endpoint)62 Platelet transfusion suggested63/ Washout: ten to 14 days61.

com ~ www. and national organizations. b.pharmacytechniciansletter. 15 major bleeds. Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. etc). c. Does not include cost of monitoring. comparable bleeding2. U. if available) from drugstore. Stockton.. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. .S.g.com ~ www. Box 8190. . Our editors have researched the information with input from experts.O.com . preprocedure washout (if indicated) No specific antidote Therapeutic Considerations INVESTIGATIONAL ORAL ANTICOAGULANT Apixaban (Eliquis): Not yet approved in U. apixaban prevents six more strokes. elderly. More. renal impairment.1  Increases risk of major bleeding when added to antiplatelet agent in patients with acute coronary syndrome. Copyright © 2011 by Therapeutic Research Center P. Based on Level A evidence unless otherwise noted.(PL Detail-Document #271001: Page 11 of 14) Drug: Mechanism Cost of 30-day supplya Approved Indications (Usual Maintenance Dose)b Clinical Benefit In…c Antidote/ pre-op.4 a.8 years. or Canada direct factor Xa inhibitor1 Not yet available A fib: at least as effective as warfarin for stroke prevention.prescribersletter. Canadian prescription drug prices from British Columbia wholesaler Kohl and Frisch Limited.pharmacistsletter.com at time of writing unless otherwise specified.1  For every 1000 A fib patients treated for 1. less major bleeding1 Post-hip/knee replacement: at least as effective as enoxaparin for preventing VTE. systemic embolism. cost for dose specified (of generic. and eight deaths compared to warfarin. Information and internet links in this article were current as of the date of publication. death.S.3  Requires BID dosing for A fib. government agencies. See product labeling for dosing in special populations (e.

et al.65:251-8. Patel MR. Yusuf S. Bristol-Myers Squibb Canada. randomised controlled trial. Lassen MR. Gallus A. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians evidence-based clinical th practice guidelines (8 edition).358:2765-75.Aug 27 [Epub ahead of print]. Dahl OE. N Engl J Med 2009. et al. How to write an evidence-based clinical review article. 21. Kakkar AK. Arnesen H. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. Product monograph for Xarelto. Kearon C. et al. Product monograph for Pradax. Rosencher N. Gallus A. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised doubleblind trial.prescribersletter.O. Singer DE. N Engl J Med 2008. QC H4S 0A4. Bauersachs R. Oral dabigatran etexilate vs. J Thromb Haemost 2007. Ageno W.363:2499510. 7. Borris LC. 25. Granger CB.com ~ www. Rosencher N. Dahl OE. 3. N Engl J Med 1990. 18. J Arthroplasty 2009. Ezekowitz MD. N Engl J Med 2009. Burlington. Pharm. Oral rivaroxaban for symptomatic venous thromboembolism. et al.361:2342-52. Choi PT. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. 24. et al. Toronto. B 12.D. Dabigatran versus warfarin in patients with atrial fibrillation. et al. 22. 13. June 2011. References 1. et al. Lancet 1960.139:893-900. March 2011. 9.375:807-15. Janssen Pharmaceuticals.(PL Detail-Document #271001: Page 12 of 14) Levels of Evidence In accordance with the trend towards Evidence-Based Medicine. Boehringer Ingelheim Canada Ltd. BCPS 16. N Engl J Med 2011. Eriksson BI. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. ON M9W 1G6.323:147-52. Jordan SC. et al. Lancet 2009. Raskob GE. Bayer Inc. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip 17. Garg J. Dalen JE.1:1309-12. Ridgefield. Eriksson BI. Friedman RJ. et al. Stockton. Douketis JD. N Engl J Med 2010.365:699-708. Product information for Xarelto. Anticoagulant drugs in the treatment of pulmonary embolism: a controlled trial. Alexander JH. 4. Apixaban versus warfarin in patients with atrial fibrillation. EINSTEIN Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. Bristol-Myers Squibb Company. 11. 5. 8. Kakkar AK. Copyright © 2011 by Therapeutic Research Center P. noninferiority trial. Lancet 2007. .pharmacistsletter. 14. Alexander JH. Turpie AG.24:1-9. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. James S.370:949-56. 2. Lassen MR. et al. September 2011. et al.com . Product monograph for Coumadin. Brenner B. Montreal. double-blind. we are citing the LEVEL OF EVIDENCE for the statements we publish. et al. N Engl J Med 2011. Titusville. et al. Davidson BL. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. Lassen MR. et al. . Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Raskob GE. Product information for Coumadin. Borris LC.com ~ www. 6.. Am Fam Physician 2002. Lopes RD. McMurray JJ. The RE-MOBILIZE Writing Committee. 20. 19. Boehringer Ingelheim Pharmaceuticals. Princeton. Eriksson BI. Albers GW. Project Leader in preparation of this PL DetailDocument: Melanie Cupp. Inc. January 2010.373:1673-80. Ann Intern Med 2003. Chest 2008. 15. Smith P. Holme I. N Engl J Med 2011. Level A Definition High-quality randomized controlled trial (RCT) High-quality meta-analysis (quantitative systematic review) Nonrandomized clinical trial Nonquantitative systematic review Lower quality RCT Clinical cohort study Case-control study Historical control Epidemiologic study Consensus Expert opinion Anecdotal evidence In vitro or animal study 10. CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www. et al. Mahaffey KW. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. Lassen MR.pharmacytechniciansletter. Linkins LA. Dahl OE. Box 8190. November 2011. ON L7L 5H4. Inc.2776-86.Aug 10 [Epub ahead of print]. Berkowitz SD. C D Adapted from Siwek J. More.133(Suppl 6):546S-592S. Barritt DW. NJ 08543. NJ 08560. November 2011.375:31-9. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind. CT 06877. Lancet 2008.5:2178-85. et al. Lancet 2010. Connolly SJ. replacement: a randomised. Apixaban with antiplatelet therapy after acute coronary syndrome.363:2487-98. The effect of warfarin on mortality and reinfarction after myocardial infarction.361:1139-51. Product information for Pradaxa. 23. Schulman S. Clinical impact of bleeding in patients taking oral anticoagulant therapy for venous thromboembolism: a meta-analysis. N Engl J Med 2011. N Engl J Med 2008.

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com. Cite this document as follows: PL Detail-Document.com . 2011. Lancet 1991. 68. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: a net clinical benefit analysis using a “real world” nationwide cohort study. 66. 67.338:1345-9. et al. Cairns JA. Lip GY. SALT Collaborative Group.O. P.pharmacytechniciansletter.pharmacistsletter. Swedish Aspirin LowDose Trial (SALT) of 75 mg aspirin as secondary prophylaxis after cerebrovascular ischaemic events. Pharmacist’s Evidence and Recommendations You Can Trust… 3120 West March Lane. on any topic covered in any issue by going to www. like this one. McMurtry S.prescribersletter. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomized controlled trial. Can J Cardiol 2011. October 2011. Letter/Prescriber’s Letter. Stockton. Meeting date September 8. or www. http://www. Olesen JB. 2011). 2011.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/Cardiovasculara ndRenalDrugsAdvisoryCommittee/UCM270796. NDA 202439.27:74-90.pdf. (Accessed November 3. Lancet 2006. Comparison of Oral Antithrombotics. Connolly S.fda. Lindhardsen J. et al. Thromb Haemost 2011. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Xarelto tablets.367:190312. Document based on applicant’s information submitted up to August 9.com.(PL Detail-Document #271001: Page 14 of 14) 64. CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249 Copyright  2011 by Therapeutic Research Center Subscribers to the Letter can get PL Detail-Documents. 65. www. The ACTIVE investigators.106:739-49. FDA draft briefing document for the Cardiovascular and Renal Drugs Advisory Committee. Box 8190.

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