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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 />

Ticagrelor – Brilinta<br />

N Engl J Med 2009;361:1045-57<br />

Endpoint<br />

Primary Composite<br />

(CV death, MI, CVA)<br />

Secondary Endpoints<br />

Ticagrelor<br />

N=9333<br />

Clopidogrel<br />

N=9291<br />

Hazard Ratio<br />

(95% CI)<br />

9.8% 11.7% 0.84<br />

(0.77-0.92)<br />

CV death 4.0% 5.1% 0.79<br />

(0.69-0.91)<br />

MI 5.8% 6.9% 0.84<br />

(0.75-0.95)<br />

Stroke 1.5% 1.3% 1.17<br />

(0.91-1.52)<br />

All cause mortality 4.5% 5.9% 0.78<br />

(0.69-0.89)<br />

In-stent thrombosis<br />

(11,289 pts with<br />

PCI/stenting)<br />

1.3% 1.9% 0.67<br />

(0.50-0.91)<br />

P-value ARR/NNT<br />

0.0003 1.9%/53<br />

0.0013 1.1%/91<br />

0.0045 1.1%/91<br />

0.22<br />

0.0003 1.4%/72<br />

0.0091 0.6%/167<br />

Ticagrelor – Brilinta<br />

N Engl J Med 2009;361:1045-57.<br />

• No significant difference in the rates of major bleeding<br />

was found between the ticagrelor and clopidogrel<br />

groups (11.6% and 11.2%, respectively; P = 0.43)<br />

• Ticagrelor was associated with a higher rate of major<br />

bleeding not related to coronary-artery bypass grafting<br />

(4.5% vs. 3.8%, P = 0.03, ARI = 0.7%, NNH = 143)<br />

including more instances of fatal intracranial bleeding<br />

and fewer of fatal bleeding of other types.<br />

• In a genetic substudy of PLATO (n=10,285), the effects<br />

of ticagrelor compared to clopidogrel on thrombotic<br />

events and bleeding were not significantly affected by<br />

CYP2C19 genotype.<br />

Wayne Weart<br />

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

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