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Daiichi Sankyo/Lilly Respond to ACCF/AHA Clinical Alert on Antiplatelet Therapy
Date:6/28/2010

nhibition of platelet aggregation.

The clopidogrel boxed warning states that patients considered "poor metabolizers" (those with two copies of the CYP2C19 variant) may have an increased risk of thrombotic cardiovascular (CV) events.  In addition, the label also notes that some patients with at least one reduced-function allele (copy) of CYP2C19 (also known as intermediate metabolizers) may also have a reduced response to clopidogrel.  The prevalence of poor metabolizers is estimated at 2 percent for Caucasians, 4 percent for Blacks, and 14 percent for Chinese. The prevalence of intermediate metabolizers is 28 percent for Caucasians, 33 percent for Blacks and 64 percent for Chinese.

In addition, the ACCF/AHA Clinical Alert suggests genetic variations in other genes, such as ABCB1, may also contribute to variability in response to clopidogrel.  A retrospective analysis of the TRITON-TIMI 38 trial suggested that patients treated with Effient with two variants in ABCB1 did not have an increased risk of thrombotic CV events when compared to patients treated with Effient without these variants.  

"The ability to convert Effient to its active metabolite is not known to be impacted by the key genetic variations discussed in the Clinical Alert," said Rogelio Braceras, MD, senior medical director, thrombosis at Daiichi Sankyo, Inc.  "In addition, other high-risk patient types mentioned in the Clinical Alert, such as those with diabetes or those who are more susceptible to recurrent events, such as STEMI patients, achieved reductions in the primary composite endpoint of CV death, nonfatal heart attack or nonfatal stroke in TRITON-TIMI 38 that were consistent with those observed in the UA/NSTEMI cohort and the overall all ACS population.  This benefit, however, should be weighed against the potential risk of clinically sign
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SOURCE Eli Lilly and Company
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