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Ezetimibe: efficacy—dose–response study

Combination Lipid-Altering Drug Therapy with Statins (Harold Bays, MD, FACP)

efficacy   ezetimibe   LDL cholesterol

In two 12-week studies, ezetimibe monotherapy significantly decreased plasma LDL-C levels and increased plasma HDL-C levels, with a tolerability profile similar to that of placebo. The 10-mg dose of ezetimibe provided greater benefit on LDL-C blood level reduction compared with 5 mg, without affecting tolerability and without any significant increase in adverse events. Therefore, the 10-mg dose of ezetimibe was chosen as the only dose for phase III clinical trials. The 10-mg dose of ezetimibe was subsequently submitted to the FDA for approval in December 2001 and was approved for clinical use in November 2002.

  1. Bays HE, Moore PB, Drehobl MA, et al., for the Ezetimibe Study Group. Effectiveness and tolerability of ezetimibe in patients with primary hypercholesterolemia: pooled analysis of two phase II studies. Clin Ther 2001;23:1209-1230.

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