New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences
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2 nd Annual Essentials in Primary Care<br />
Fall Conference<br />
Friday, November 11, <strong>2011</strong><br />
Dabigatran- Pradaxa<br />
• Compared to warfarin, both doses of dabigatran<br />
were associated with a significantly lower rate of<br />
haemorrhagic stroke, life-threatening bleeds, and<br />
intracranial haemorrhage (ICH) with and without<br />
haemorrhagic stroke; dabigatran 110 mg also<br />
showed a significant reduction in major bleeding<br />
compared to warfarin<br />
• Warfarin has statistically significantly fewer GI bleeds<br />
compared to both doses of dabigatran, and<br />
significantly fewer major GI bleeds and lifethreatening<br />
GI bleeds than dabigatran 150 mg<br />
Dabigatran- Pradaxa<br />
• The rates of adverse reactions leading to treatment<br />
discontinuation in RE-LY were 21% for dabigatran 150 mg and<br />
16% for warfarin. The most frequent adverse reactions<br />
leading to discontinuation of dabigatran were bleeding and<br />
gastrointestinal events (i.e., dyspepsia, nausea, upper<br />
abdominal pain, gastrointestinal hemorrhage, and diarrhea).<br />
– NNH 20 patients<br />
• <strong>Drug</strong> Interactions<br />
– The concomitant use of dabigatran with P-gp inducers<br />
(e.g., rifampin) reduces exposure to dabigatran and should<br />
generally be avoided<br />
– P-gp inhibitors ketoconazole, verapamil, amiodarone,<br />
quinidine, and clarithromycin do not require dose<br />
adjustments<br />
Wayne Weart<br />
<strong>New</strong> <strong>Drug</strong> <strong>Update</strong> Part I