torvastatin 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]
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 extension.
A multicenter, double-blind, controlled, 14-week study was conducted in 621 patients with heterozygous familial hypercholesterolemia (HeFH), coronary heart disease (CHD), or multiple cardiovascular risk factors (≥2), adhering to an NCEP Step I or stricter diet. All patients received atorvastatin 10 mg for a minimum of 4 weeks prior to randomization. Patients were then randomized to receive either coadministered ezetimibe and atorvastatin (equiva |
