GSK's darapladib prevents necrotic core expansion

UK drug major GlaxoSmithKline says that results of the IBIS-2 study showed that use of the selective lipoprotein-associated phospholipase A2 inhibitor darapladib, in addition to standard-of-care treatment, prevented expansion of the necrotic core, a region within coronary plaque associated with a high risk of rupture.

Presented at the 2008 Congress of the European Society of Cardiology, in Munich, Germany, results from the year-long Phase II exploratory trial showed that the co-primary endpoints of plaque deformability and plasma levels of hsCRP, had no significant differences between darapladib and placebo treatment groups, but trended positively.

Key secondary endpoints showed significant effects of darapladib on plaque composition and plasma levels of Lp-PLA2 activity. On average, after 12 months, patients treated with placebo experienced a significant increase in necrotic core volume (p=0.009 versus baseline) while expansion of the necrotic core was halted in the darapladib-treated group (p=0.71 vs baseline).