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A Tale of 2 Lipid-Altering Drugs

Bruce M. Psaty, MD, PhD; Thomas Lumley, PhD

JAMA. 2008;299(12):1474-1476.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Risk factors such as high blood pressure, elevated low-density lipoprotein (LDL) cholesterol levels, and high blood glucose levels are strongly, consistently, and directly associated with the risk of major cardiovascular events, including myocardial infarction, stroke, and heart failure. Over the last several decades, the development and widespread use of drugs to reduce the level of these risk factors have been a mainstay of cardiovascular disease prevention efforts.

For new drugs designed to treat these conditions, the US Food and Drug Administration (FDA) generally uses their treatment effects on the level of the risk factor to evaluate them for approval. Risk-factor levels serve as surrogate end points for the outcomes of primary interest—the incidence of cardiovascular disease. According to the FDA guidance on lipid-lowering therapy, "The objective of lipid-altering therapy is not merely to alter serum lipids but to diminish the morbidity and . . . [Full Text of this Article]

Ezetimibe

Author Affilliations: Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, Health Services (Dr Psaty) and Biostatistics (Dr Lumley), University of Washington; and Center for Health Studies, Group Health (Dr Psaty), Seattle, Washington.