perlipidemia, 628 patients were treated for up to 12 weeks and 246 for up to an additional 48 weeks. Patients were randomized to receive placebo, ezetimibe (10 mg), atorvastatin (10 mg, 20 mg, 40 mg, or 80 mg), or coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET (10/10, 10/20, 10/40, and 10/80) in the 12-week study. After completing the 12-week study, patients who agreed to participate in the study extension were assigned to coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET (10/10-10/80) or atorvastatin (10-80 mg/day) for an additional 48 weeks.
The patient population was: 59% female; 85% Caucasian, 6% Black, 3% Asian, 5% Hispanic, 1% American Indian, <1% other; 18 to 86 years of age (mean age 57 years).
Patients receiving all doses of LIPTRUZET were compared to those receiving all doses of atorvastatin. LIPTRUZET lowered total-C, LDL-C, Apo B, TG, and non-HDL-C, and increased HDL-C significantly more than atorvastatin alone. (See Table 9.)
Table 9: Response to LIPTRUZET in Patients with Primary Hyperlipidemia (Mean * % Change from Untreated Baseline † at 12 weeks) Treatment(Daily Dose) N Total-C[Baseline ‡] LDL-C[Baseline ‡] Apo B[Baseline ‡] TG *[Baseline ‡] HDL-C[Baseline ‡] Non-HDL-C[Baseline ‡]
* For triglycerides, median % change from baseline
† Baseline -- on no lipid-lowering drug
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ LIPTRUZET pooled (10/10-10/80) significantly reduced total-C, LDL-C, Apo B, TG, non-HDL-C, and significantly increased HDL-C compared to all doses of atorvastatin pooled (10-80 mg).
Pooled data (All LIPTRUZET doses)§ 255 -41%[267] -56%[182] -45%[170] -33%[165] +7%[50.8] -52%[217]
Pooled data (All atorvastatin doses)§ 248 -32%[269] -44%[181] -36%[168] -24%[155] +4%[53.7] -41%[215]
Ezetimibe 10 mg 65 -14%[259] -20%[177] -15%[167] -5%[145] +4%[50.6] -18%[209]
Placebo 60 +4%[262] +4%[180] +3%[168] -6%[143] +4%[50.4] +4%[212]
LIPTRUZET by dose
10/10 65 -38%[262] -53%[177] -43%[165] -31%[158] +9%[51.9] -49%[211]
10/20 62 -39%[269] -54%[184] -44%[174] -30%[165] +9%[49.3] -50%[220]
10/40 65 -42%[271] -56%[184] -45%[173] -34%[180] +5%[51.1] -52%[220]
10/80 63 -46%[267] -61%[183] -50%[169] -40%[146] +7%[50.9] -58%[216]
Atorvastatin by dose
10 mg 60 -26%[271] -37%[185] -28%[168] -21%[153] +6%[53.7] -34%[217]
20 mg 60 -30%[267] -42%[177] -34%[164] -23%[147] +4%[55.5] -39%[211]
40 mg 66 -32%[266] -45%[180] -37%[167] -24%[159] +4%[53.0] -41%[213]
80 mg 62 -40%[270] -54%[184] -46%[171] -31%[163] +3%[52.7] -51%[218]
For triglycerides, median % change from baseline
† Baseline -- on no lipid-lowering drug
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ LIPTRUZET pooled (10/10-10/80) significantly reduced total-C, LDL-C, Apo B, TG, non-HDL-C, and significantly increased HDL-C compared to all doses of atorvastatin pooled (10-80 mg).
The changes in lipid endpoints after an additional 48 weeks of treatment with LIPTRUZET (all doses) or with atorvastatin (all doses) were generally consistent with the 12-week data displayed above in the 245 subjects (out of the 576 who completed the 12-week study) who agreed to participate in the study extensi
