New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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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
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Dabigatran- Pradaxa ACCF/AHA/HRS 2011 Focused Update Recommendation Class I “Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance 50 mL/min, start warfarin 3 days before discontinuing dabigatran. – For CrCl 31-50 mL/min, start warfarin 2 days before discontinuing dabigatran. – For CrCl 15-30 mL/min, start warfarin 1 day before discontinuing dabigatran. Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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