In SOLID-TIMI 52, men and women with ACS and receiving standard of care will be randomised 1:1 to once-daily doses of darapladib 160 mg enteric-coated tablets or placebo. The study will be stopped when approximately 1500 reports of first occurrence of a major adverse coronary event (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke have occurred. This is estimated to be in approximately three years, with interim independent analyses planned. It is anticipated that most subjects will be dosed for a minimum of 2 years and up to 3.5 years or more. The secondary objectives of SOLID-TIMI 52 are to evaluate whether darapladib has an impact on the occurrence of major and total coronary events including coronary heart disease death, non-fatal heart attack, urgent and non-urgent coronary revascularisation, hospitalisation for unstable angina and all-cause mortality. Additional safety data will also be collected. About Darapladib and Lp-PLA2
Darapladib is a selective and orally active inhibitor of LpPLA2 currently in Phase III development as a potential anti-atherosclerosis agent. Darapladib is being investigated to determine whether it can reduce the occurrence of major cardiovascular events in patients with coronary heart disease. Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque. The underlying process in most heart attacks and strokes is atherosclerosis, which is an inflammatory disease characterised by the build-up of plaque within the walls of arteries. The rupture of unstable atherosclerotic plaque, regardless of the size of the plaque, causes most heart attacks and strokes. Elevated Lp-PLA2 activity has been implicated in the development and progression of atherosclerosis. Large amounts of Lp-PLA2 are present in the necrotic core of rupture-prone human coronary plaques. About Acute Coronary Syndrome (ACS)
Acute Coronary Syndrome is a term used for any condition brought on by sudden reduced flow to the heart. It includes unstable angina (increasing unpredictable chest pain) and heart attack.2 ACS may develop slowly over time by the build-up of plaques in the arteries of the heart. Coronary artery disease is the leading cause of death globally and the single largest killer of Americans. According to the World Health Organization (WHO), 7.2 million people worldwide die each year from CAD and more than 12 million die from a heart attack or stroke. GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.