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Lp-PLA2 PREDICTS CORONARY HEART DISEASE Study of the ARIC Population Published in Circulation South San Francisco, CA - February 2, 2004 - A prospective, case cohort study of the Atherosclerosis Risk in Communities (ARIC) population, published today in the online edition of Circulation, the Journal of the American Heart Association, supports the measurement of lipoprotein-associated phospholipase A2 (Lp-PLA2) to help identify individuals at risk for coronary heart disease (CHD). The research team, led by researchers at Baylor College of Medicine and Methodist DeBakey Heart Center, examined the relationship between Lp-PLA2, C-reactive Protein (CRP), traditional risk factors and the risk for a CHD event over the course of six to eight years stratified by low-density lipoprotein (LDL) cholesterol. The results of the study show mean levels of Lp-PLA2 and CRP were higher in the 608 men and women who developed CHD events than a matched group of 740 individuals who remained free of CHD, after adjustment for age, sex and race. The study also determined that for individuals with LDL cholesterol below the median (130 mg/dL), both Lp-PLA2 and CRP were significantly and independently associated with CHD in fully adjusted models. Individuals with normal LDL levels (<130 mg/dL) but elevated Lp-PLA2 levels were shown to be at twice the risk for a coronary event compared to individuals with low levels of Lp-PLA2. Moreover, individuals with normal LDL levels, but elevated levels of both Lp-PLA2 and CRP, had three times the risk for a cardiac event. "In the current guidelines, drug therapy is not recommended in primary prevention of CHD for individuals with LDL cholesterol below 130 mg/dL. However, in the ARIC population, one third of all coronary events occurred in individuals with LDL below these levels, which is consistent with observations in other clinical studies," said Christie M. Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention at Baylor College of Medicine and the Methodist DeBakey Heart Center, Houston, and lead author of the study. "Novel blood tests to measure Lp-PLA2 and high-sensitivity CRP help assess CHD risk in patients with low LDL cholesterol. An Lp-PLA2 measurement with the PLAC™ test helps identify those who may benefit from risk-reduction interventions, such as improved diet, exercise and drug therapy, before a coronary event occurs." Lp-PLA2 levels in the ARIC population were measured using the PLAC test. The test, developed by diaDexus, Inc., is a blood test cleared by the U.S. Food and Drug Administration to aid in the prediction of an individual's risk for a CHD event, in conjunction with clinical evaluation and patient risk assessment. Lp-PLA2 testing is currently available through laboratories nationwide. For more information about the PLAC test visit www.plactest.com. Scientists at GlaxoSmithKline (GSK) discovered Lp-PLA2 and have postulated that Lp-PLA2 plays a role in atherosclerosis by causing an inflammatory process, resulting in the build-up of plaque on the arterial walls. Lp-PLA2 is an enzyme, usually bound to LDL cholesterol in the blood, and has been found to be present in plaque. The scientists hypothesized that the enzymatic action of Lp-PLA2 yielded inflammatory mediators leading to CHD. GSK is developing an Lp-PLA2 inhibitor as a potential anti-atherosclerosis therapy. GSK expects the Lp-PLA2 inhibitor will move into Phase III trials in 2004. GSK has exclusively licensed certain intellectual property relating to Lp-PLA2 and the PLAC test to diaDexus for clinical diagnostics. This study was funded by a research grant from the National Heart, Blood, and Lung Institute and diaDexus, Inc. About diaDexus |
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