The novel darapladib (GlaxoSmithKline) demonstrated no advantage over placebo in regards to the study’s primary endpoint in patients with chronic coronary heart disease treated with a high level of background care, as presented at the American College of Cardiology’s 63d Annual Scientific Session.
Darapladib is a strong inhibitor of Lp-PLA2, a biomarker of inflammation in blood vessels. High Lp-PLA2 levels are a risk factor for coronary heart disease and, in animal models, are linked with vulnerable plaque that can lead to heart attacks and strokes.
STABILITY, a Phase 3 double-blind trial, was the first to test the inflammation-prevention mechanism in reducing the likelihood that plaque will become an artery-blocking clot. The study randomized 15,828 patients with chronic coronary heart disease to receive darapladib 160mg or placebo once daily. The primary endpoint was time to first heart attack, stroke, and death from cardiovascular causes. Darapladib did not meet this endpoint as it showed no significant benefit–769 events (9.7%) vs. 819 events (10.4%) for placebo.
Regarding a secondary endpoint, a reduction in major coronary events related to the arteries (eg, heart attack, urgent need for angioplasty or bypass surgery, or death) was nominally significant. Treatment with darapladib shad a 10% risk reduction with 737 major coronary events (9.3%) vs. 814 events (10.3%) in the placebo group.
Study authors also found that smokers had a greater decrease in major adverse cardiovascular events than non-smokers. They noted that additional analysis of biomarkers, including Lp-PLA2 levels and genetic sub-studies may help provide insight about the drug’s potential on the prevention of coronary events in patients with stable coronary heart disease.
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