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.
- 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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