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

Most Common Adverse EventsDabigatran 150 mg bidOnly oraltreatmentn = 1226Overalln = 1273WarfarinOnly oraltreatmentn = 1214Overalln = 1266Headache (%) 60 (4.9) 79 (6.2) 64 (5.3) 88 (7.0)Pain in extremity(%)59 (4.8) 64 (5.0) 69 (5.7) 71 (5.6)Nausea (%) 43 (3.5) 49 (3.8) 43 (3.5) 58 (4.6)Diarrhea (%) 46 (3.8) 57 (4.5) 34 (2.8) 38 (3.0)Nasopharyngitis(%)47 (3.8) 50 (3.9) 53 (4.4) 54 (4.3)Dyspnea (%) 33 (2.7) 41 (3.2) 47 (3.9) 53 (4.2)Back pain (%) 42 (3.4) 46 (3.6) 44 (3.6) 50 (3.9)Arthralgia (%) 45 (3.7) 48 (3.8) 30 (2.5) 33 (2.6)Peripheraledema(%)41 (3.3) 43 (3.4) 45 (3.7) 48 (3.8)Dyspepsia (%) 36 (2.9) 39 (3.1) 7 (0.6) 9 (0.7)**p3 x ULN (%) 38 (3.1) 25 (2.1)AST >3 x ULN (%) 42 (3.4) 46 (3.8)ALT >3 x ULN +bilirubin >2 x ULN(%)2 (0.2) 4 (0.4)Schulman S et al. N Engl J Med 2009:361:2342-52RE-LY: A Non-Inferiority TrialPrimary Outcome: Superiority AnalysisP=.34P=.41Blinded Event Adjudication.OpenWarfarinadjusted(INR 2.0-3.0)N=6015Atrial fibrillation≥1 Risk FactorAbsence of contra-indications951 centers in 44 countriesRDabigatranEtexilate110 mg BIDN=6076BlindedDabigatranEtexilate150 mg BIDN=6022•Performed12/05-03/09•Median follow up2.0 years•Follow up 99.9%complete•Mean TTR = 64%(patients onwarfarin)Annual Rate3.0%2.5%2.0%1.5%1.0%0.5%0.0%P