| Summary: | In December 2006 the Food and Drug Administration (FDA) held a public hearing on lipoprotein subfractions (www.fda.gov/OHRMS/DOCKETS/ac/06/transcripts/2006-4263t1-01t.pdf, accessed Feb 19, 2008). Several questions were formulated from this meeting regarding the use of low density lipoprotein (LDL) (and high density lipoprotein (HDL)) subfractions for clinical decision making. Based on this hearing, the Centers for Medicare & Medicaid Services (CMS) requested a review of the literature on LDL subfractions and the risk of cardiovascular heart disease (CVD). After an early overview of the potentially relevant literature by the Tufts Evidence-based Practice Center (Tufts EPC), the questions of interest for this report were restricted to a description of the measurement methods that potentially could be routinely used by clinical laboratories, comparisons of the different measurement methods, a review of the evidence regarding the association between LDL subfractions and CVD, and a review of studies that evaluated an intervention that may "improve" LDL subfraction profiles and also evaluated cardiovascular outcomes. The primary population of interest for this review is the over age 65 Medicare population; however, data from all adults are also of interest to CMS.
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