Dabigatran & Rivaroxaban Rat Poison in Better Packaging?

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1 & 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 are rophylaxis rthopedic Surgery Elective Hip Replacement LMWH, starting 12 h before surgery or h after surgery, or 4-6 h after surgery at half usual dose & to usual dose following day fondaparinux 2.5 mg 6-24 h after surgery adjusted-dose VKA started preop or evening of surgical day (NR target = 2.5; NR range= 2-3) High risk bleeding = mechanical thromboprophylaxis with venous foot pump (VF) or intermittent pneumatic compression () rophylaxis LMWH, fondaparinux, or adjusted-dose VKA (NR target = 2.5; NR range = 2-3) Alternative = Grade 1B High risk of bleeding () VF (Grade 1B) hest 2008;133:381S-453S hest 2008;133:381S-453S rophylaxis Knee Arthroscopy No risk factors Early mobilization (Grade 2B) Thromboembolic risk factors or following a complicated procedure, LMWH (Grade 1B) Hip Fracture Surgery Fondaparinux () LMWH (Grade 1B) Adjusted dose VKA (NR target = 2.5; NR range = 2-3) [Grade 1B] Low dose UH (Grade 1B) Surgery is delayed, start thromboprophylaxis with LMWH or low dose UH (Grade 1) High risk of bleeding Mechanical thromboprophylaxis () hest 2008;133:381S-453S rophylaxis Surgery THR TKR HFS 10 days Duration of therapy Up to 35 days Grade 2B Risk factors: previous VTE, current obesity, delayed mobilization, advanced age, & cancer hest 2008;133:381S-453S

2 Notice f ompliance - Mechanism of Action - Notice of ompliance June 10, 2008 Uses revention of DVT/E in pts undergoing elective total hip or total knee replacement Dosing mg po daily es 2009; Monograph ADME - Absorption F = 6.5% Requires acidic environment eak plasma concentrations = 6 hrs Distribution Vd = L/kg ~35% protein bound Metabolism Rapidly & completely converted from pro-drug (dabigatran etexilate) to active form (dabigatran) Elimination Excreted unchanged in the urine primarily via glomerular filtration Notice of ompliance Notice of ompliance September 15, 2008 Uses revention of DVT/E in pts undergoing elective total hip or total knee replacement Dosing 10 mg po daily es 2009; Monograph es 2009; Monograph Mechanism of Action - ADME - Absorption F = 100% eak plasma concentrations = 2-4 hrs Distribution Vd = 0.7 L/kg ~95% protein bound Metabolism Y 3A4, Y 2J2, & Y-independent mechanisms Elimination 1/3 excreted unchanged in the urine 1/3 excreted as inactive metabolites in the urine 1/3 excreted as inactive metabolites via fecal route es 2009; Monograph

3 rthopedic Literature RE-NVATE R,DB, n = 3494 ts with total hip replacement dabigatran 150 mg po daily (n = 1174) x days R dabigatran 220 mg po daily (n = 1157) x days vs. enoxaparin 40 mg S daily (n = 1162) x days symptomatic) & death from all causes during treatment Non-inferiority margin = 7.7% Lancet 2007; 370: RE-NVATE RE-MDEL rimary endpoint 150 mg: 8.6% 220 mg: 6.0% Enoxaparin: 6.7% Author s onclusions was as effective as enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery, with a similar safety profile Lancet 2007; 370: R,DB, n = 2076 ts with total knee replacement dabigatran 150 mg po daily (n = 708) x 6-10 days R dabigatran 220 mg po daily (n = 694) x 6-10 days vs. enoxaparin 40 mg S daily (n = 699) x 6-10 days during treatment Non-inferiority margin = 9.2% J Thromb Haemost 2007; 5: RE-MDEL RE-MBLZE rimary endpoint 150 mg: 40.5% 220 mg: 36.4% Enoxaparin: 37.7% Author s onclusions was at least as effective as enoxaparin & had a similar safety profile for prevention of VTE after total knee replacement surgery J Thromb Haemost 2007; 5: R,DB, n = 2615 ts with total knee replacement dabigatran 150 mg po daily x days R dabigatran 220 mg po daily x days vs. enoxaparin 30 mg S BD x days during treatment Non-inferiority trial J Thromb Haemost 2007; 5(Suppl 2):-W-050

4 rimary endpoint RE-MBLZE 150 mg: 33.7% 220 mg: 31.1% Enoxaparin: 25.3% was inferior to enoxaparin rthopedic Literature J Thromb Haemost 2007; 5(Suppl 2):-W-050 RERD 1 RERD 1 R,DB, n = 4541 ts with total hip arthroplasty rivaroxaban 10 mg po daily (n = 1595) x days vs. enoxaparin 40 mg sc daily (n = 1558) x days rimary endpoint : 1.1% Enoxaparin: 3.7% Author s onclusion was significantly more effective than enoxaparin for extended VTE prophylaxis following THA, with similar bleeding rates RERD 2 RERD 2 R,DB, n = 2509 ts with total hip arthroplasty rivaroxaban 10 mg po daily (n = 1252) x days vs. enoxaparin 40 mg sc daily (n = 1257) x days rimary endpoint : 2% Enoxaparin: 9.3% Author s onclusion Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin for the prevention of venous thromboembolism, in patients undergoing total hip arthroplasty

5 RERD 3 RERD 3 R,DB, n = 2531 ts with total knee arthroplasty rivaroxaban 10 mg po daily (n = 1254) x days vs. enoxaparin 40 mg sc daily (n = 1277) x days rimary endpoint : 9.6% Enoxaparin: 18.9% Author s onclusion Extended thromboprophylaxis with rivaroxaban was significantly more effective than enoxaparin for venous thromboembolism prophylaxis, in patients undergoing total knee arthroplasty Summary & onclusions Summary & onclusions Total Hip Replacement May have a role with extended treatment, but has not been compared to appropriate doses of enoxaparin ontinue to use LMWH May be an option in patients not willing to take injections &/or undergo NR monitoring No role vs. enoxaparin at this time Last alternative AFTER other therapeutic options Total Hip Replacement May have a role with extended treatment, but has not been compared to appropriate doses of enoxaparin ontinue to use LMWH An option in patients not willing to take injections &/or undergo NR monitoring May have a role, but has not been compared to appropriate doses of enoxaparin ption in patients not willing to take injections &/or undergo NR monitoring ngoing & Future Studies Recurrent symptomatic VTE, acute symptomatic VTE, elective percutaneous coronary intervention, atrial fibrillation, acute coronary syndromes Acute coronary syndromes, atrial fibrillation, prevention of recurrent symptomatic VTE, acute symptomatic DVT/E, VTE prophylaxis in medical patients

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