Effient prasugrel: Additional Phase III data

A subgroup analysis of 1,454 patients treated with Plavix clopidogrel in the Phase III TRITON-TIMI 38 trial showed that patients who were either homozygous for the C3435T variant in the P glycoprotein ( MDR1; ABCB1; P-gp; CD243) gene, cytochrome P450 2C19 (CYP2C19) reduced-function allele carriers, or both (n=681) had a significantly higher rate of the composite incidence of CV death, non-fatal heart attack and non-fatal stroke vs. Plavix-treated patients who did not carry at-risk genotypes in either gene (n=773; HR=1.97, 95% CI: 1.38, 2.82, p=0.0002). Data were published in The Lancet.

The partners previously reported that Effient met the primary endpoint of significantly reducing the composite incidence of CV death, non-fatal heart attack and non-fatal stroke vs. Plavix in all 13,608 patients in the trial (see BioCentury, Nov. 12, 2007). In March, a subgroup analysis of 2,943 patients tested for the C3435T variant in the trial showed that patients treated with Plavix who had two C3435T variants had a significantly higher rate of the composite endpoint vs. Plavix-treated patients without the variant (see BioCentury, March 22). ...