New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Dabigatran- Pradaxa
• Compared to warfarin, both doses of dabigatran
were associated with a significantly lower rate of
haemorrhagic stroke, life-threatening bleeds, and
intracranial haemorrhage (ICH) with and without
haemorrhagic stroke; dabigatran 110 mg also
showed a significant reduction in major bleeding
compared to warfarin
• Warfarin has statistically significantly fewer GI bleeds
compared to both doses of dabigatran, and
significantly fewer major GI bleeds and lifethreatening
GI bleeds than dabigatran 150 mg
Dabigatran- Pradaxa
• The rates of adverse reactions leading to treatment
discontinuation in RE-LY were 21% for dabigatran 150 mg and
16% for warfarin. The most frequent adverse reactions
leading to discontinuation of dabigatran were bleeding and
gastrointestinal events (i.e., dyspepsia, nausea, upper
abdominal pain, gastrointestinal hemorrhage, and diarrhea).
– NNH 20 patients
• Drug Interactions
– The concomitant use of dabigatran with P-gp inducers
(e.g., rifampin) reduces exposure to dabigatran and should
generally be avoided
– P-gp inhibitors ketoconazole, verapamil, amiodarone,
quinidine, and clarithromycin do not require dose
adjustments
Wayne Weart
New Drug Update Part I