Clinical efficacy of cholesterol absorption inhibitors as lowdensity lipoprotein cholesterollowering agents

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Since dietary intake accounts for up to a third of plasma cholesterol levels and a redundant system in the enterohepatic recirculation is used to reabsorb and conserve cholesterol-derived bile acids and steroidal intermediates, various inhibitors of cholesterol absorption have been explored to identify alternative lipid-lowering agents. Such agents should provide an advantage over a simple low-fat diet and have particular benefit for patients who either do not respond or are unable to tolerate statin therapy. Ezetimibe 10 represents the first cholesterol absorption inhibitor approved for LDLc lowering. In clinical studies, daily doses of 0.25-10 mg of ezetimibe as monotherapy were safe and well-tolerated, and did not alter the plasma concentrations of lipid-soluble vitamins. In this study, ezetimibe dose-dependently lowered plasma LDLc, and the 10 mg dose lowered LDLc by 17-18% in hypercholesterolemic patients after 12 weeks of dosing.52 There was no statistically significant change in HDLc after 12 weeks. No long-term safety studies have yet been reported. Ezetimibe represents the first drug approved for lipid lowering that acts by an alternate mechanism since the statins were discovered.

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