Out with the Old and in with the New? Target Specific Anticoagulants for Atrial Fibrillation Goal Statement Pharmacists and technicians will gain knowledge in the use of target specific oral anticoagulants (TSOACs) used for prevention of stroke in. Objectives For Pharmacists: Compare the pharmacology between target specific oral anticoagulants Recall two differences in dosing strategies for the target specific oral anticoagulants Select optimal medication therapy for stroke prevention in patients with using the 2012 CHEST guidelines Identify appropriate patients to receive target specific oral anticoagulant therapy using efficacy and safety data from the,, and trials Describe three roles for a pharmacist in the management of target specific oral anticoagulant therapy For Technicians: Recognize available dosage forms and appropriate dosing strategies for the target specific oral anticoagulants Define the technician s role in the appropriate dispensing of target specific oral anticoagulant therapy FDA Approved Indications Dabigatran (Pradaxa) Rivaroxaban (Xarelto) Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery Treatment of DVT, PE, and reduction in the risk of recurrence of DVT and PE Apixaban (Eliquis)
Mechanism of Action Study Characteristics Comparison Study Design Randomized, open label Randomized, double blind, double dummy Randomized, double blind, double dummy Analysis Non inferiority Non inferiority Non inferiority # 18,113 14,264 18,201 Follow up 2 years 1.9 years 1.8 years Treatment Intervention Blinded dabigatran BID or BID Rivaroxaban 20 mg daily Apixaban 5 mg BID Comparator Intervention Open label dose adjusted warfarin Dose adjusted warfarin Dose adjusted warfarin
Population Comparison Age (years) 71.5 ± 8.7 73 (65 78) 70 (63 76) Weight (kg) 82.9 ± 19.9 82 (70 96) BMI (kg/m 2 ) 28.3 (25.2 32.1) Male sex (%) 63.6 61.3 64.5 CHADS 2 (mean) 2.1 3.5 2.1 Efficacy Comparison Rate of stroke or systemic embolism, treatment 1.53 0.91 (0.74 1.11) 1.11 0.66 (0.53 0.82) 2.1 0.88 (0.75 1.03) 1.27 0.79 (0.66 0.95) p(s)<0.001 p(s)=0.12 p(s)=0.01 Rate of stroke or systemic embolism, warfarin *NI=non inferiority; S=superiority 1.69 1.69 2.4 1.6 Safety Comparison: Major Bleeding Major bleeding, treatment 2.71 0.80 (0.69 0.93) 3.11 0.93 (0.81 1.07) 3.6 1.04 (0.90 1.20) 2.13 0.69 (0.60 0.80) p=0.003 p=0.31 p=0.58 Major bleeding, warfarin 3.36 3.36 3.4 3.09
Safety Comparison: Intracranial Bleeding Intracranial bleeding, treatment 0.23 0.31 (0.20 0.47) 0.30 0.40 (0.27 0.60) 0.5 0.67 (0.47 0.93) 0.33 0.42 (0.30 0.58) p=0.02 Intracranial bleeding, warfarin 0.74 0.74 0.7 0.80 Safety Comparison: Gastrointestinal (GI) Bleeding GI bleeding, treatment 1.12 1.10 (0.86 1.41) 1.51 1.50 (1.19 1.89) 3.2 0.76 0.89 (0.70 1.15) P=0.43 p=0.37 GI bleeding, warfarin 1.02 1.02 2.2 0.86
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