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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 />

Table 1: Event rates by INR time in range vs dabigatran 110 BID and 150 mg BID<br />

Event %/yr<br />

Stroke* +<br />

SEE<br />

Warf<br />

n=6022<br />

Warf Q 4<br />

TTR < 53%<br />

Warf Q 1-2<br />

TTR > 67%<br />

Dabig 110<br />

n=6015<br />

Dabig 150<br />

n=6076<br />

1.69 2.2 1.3 1.53 1.11**<br />

NNT 173<br />

Maj Bld 3.36 4.6 2.7 2.71** 3.11<br />

MI 0.53 Na Na 0.72 0.74**<br />

NNH 476<br />

Comp. 7.64 11.9 5.3 7.09 6.91<br />

*"Stroke" includes hemorrhagic stroke, **stat. sig. vs warfarin in original report.<br />

Comp = Stroke, systemic embolism, MI, PE, death, major bleeding. Warf 4th quartile = ITTR < 53.4%,<br />

1st & 2nd quartile = ITTR > 67.1%.<br />

N Engl J Med 2009; 361:1139-1151<br />

Dabigatran- Pradaxa<br />

Risk of extracranial and intracranial bleeding (% per year) by age<br />

End point<br />

Warfarin<br />

(%)<br />

Dabigatran 110<br />

mg (%)<br />

Dabigatran 150<br />

mg (%)<br />

P<br />

Extracranial bleeding<br />

Age 75 3.44 4.10 4.68 0.001<br />

Intracranial bleeding<br />

Age 75 1.00 0.37 0.41 0.28<br />

Circulation <strong>2011</strong>;123:2363-2372<br />

Wayne Weart<br />

<strong>New</strong> <strong>Drug</strong> <strong>Update</strong> Part I

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