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Heart Disease Treatment Darapladib Fails Phase III Trial
Disappointing results have been reported from the phase III STABILITY (STabilization of Atherosclerotic Plaque By Initiation of DarapLadIb TherapY) trial, which evaluated the efficacy of an investigational lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, darapladib (GlaxoSmithKline), in adults with chronic coronary heart disease (CHD).
The study did not meet it primary endpoint measure of the time to first occurrence of any major adverse cardiovascular event (MACE) from the composite of myocardial infarction (heart attack), stroke, and cardiovascular death (relative risk reduction of 6%; P = 0.199).
The trial showed no major imbalance in serious adverse events between the active and placebo groups. Frequently reported adverse events included diarrhea and odor.
Darapladib is a selective and orally active inhibitor of Lp-PLA2 that is being investigated as a potential agent for the reduction of cardiovascular events in patients with coronary heart disease. Lp-PLA2 is an enzyme that is found in blood and in atherosclerotic plaques.
Atherosclerosis is characterized by the build-up of plaques of fat, cholesterol, and other substances within the walls of arteries and is, in part, an inflammatory disease. When these plaques rupture, they can block vital blood vessels, causing acute coronary syndromes (heart attacks) and strokes. Elevated Lp-PLA2 activity has been implicated in the development and progression of atherosclerosis.
Source: GlaxoSmithKline; November 12, 2013.