New Drugs Antiplatelets-Antithrombotics - John Fanikos, RPh, MBA ...

Common Adverse EventsAdverse events occurring in>5% of any groupDabigatran110 mg%Dabigatran150 mg%Warfarin%Dyspepsia * 11.8 11.3 5.8Dyspnea 9.3 9.5 9.7Dizziness 8.1 8.3 9.4Peripheral edema 7.9 7.9 7.8Fatigue 6.6 6.6 6.2Cough 5.7 5.7 6.0Chest pain 5.2 6.2 5.9Arthralgia 4.5 5.5 5.7Back pain 5.3 5.2 5.6Nasopharyngitis 5.6 5.4 5.6Diarrhea 6.3 6.5 5.7Atrial fibrillation 5.5 5.9 5.8Urinary tract infection 4.5 4.8 5.6Upper respiratory tract infection 4.8 4.7 5.2*Occurred more commonly on dabigatran p3x ULNWarfarin Dabigatran110Dabigatran1500 0.5 1.0 1.5 2.0 2.5Years of Follow-upTargetPopulationStudy Design: Phase III TrialsRE-MOBILIZE RE-MODELTKR TKR THRRE-NOVATEDabigatran Dose 150 & 220 mg 150 & 220 mg 150 & 220 mg1 st DoseEnoxaparinDoseTreatmentDurationPrimaryEndpointNon-inferioritymargin6 to12 hourspost-op30 mg Twicedaily*1 to 4 hourspost-op1 to 4 hourspost -op40 mg Daily† 40 mg Daily†12 to15 days 6 to 10 days 28 to 35 daysTotal VTE + allcausemortalityTotal VTE + allcausemortality9.2 % 9.2% 7.7%Total VTE + allcausemortality*Commenced 12-24 h post surgery; †Commenced evening before surgery.Dabigatran vs Enoxaparin for Prevention ofVTE after Orthopedic Surgery• 3 trials vs Enoxaparin• Met non-inferioritymargins in 2 of 3• Overall rates of majorbleeding were low.40%30%20%10%0%P=.02, P