Cholesterol Drug Lowers LDL-C Levels But Again Fails to Show Clinical Benefit

Abstract

ORLANDO—A small study of 2 cholesterol-modifying drugs presented at the American Heart Association’s annual Scientific Sessions held here in November prompted comments and questions involving much larger issues, ranging from physician prescribing patterns to the role of clinical effectiveness in drug approvals. The study compared 2 treatment strategies, using statin therapy and adding either ezetimibe or extendedrelease niacin, to diminish cardiovascular disease risk by modifying cholesterol levels in men and women with coronary heart disease or a coronary heart disease risk equivalent: diabetes mellitus, a 10-year Framingham risk score (used to estimate risk of coronary heart disease) of 20% or more, or a coronary calcium score above 200 for women or 400 for men. Ezetimibe reduced levels of lowdensity lipoprotein cholesterol (LDL-C), a surrogate marker for reducing cardiovascular disease risk, by 17.6 mg/dL compared with a reduction of 10.0 mg/dL for those taking extendedrelease niacin. But extended-release niacin proved superior to ezetimibe as an add-on therapy to statins as determined by measuring carotid intimamedia thickness, a surrogate measurement for atherosclerosis progression or regression (Taylor AJ et al. N Engl J Med. 2009;361[22]:2113-2122). The findings are another blow against the beleaguered but highly prescribed ezetimibe, an inhibitor of intestinal cholesterol absorption, licensed by the US Food and Drug Administration (FDA) in 2002 based on its ability to reduce levels of LDL-C. Reducing LDL-C to specified levels is a validated target of therapy as established by national treatment guidelines. However, no trial has yet shown the drug actually provides