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 (equivalent to LIPTRUZET 10/10) or atorvastatin 20 mg/day monotherapy. Patients who did not achieve their LDL-C target goal after 4 and/or 9 weeks of randomized treatment were titrated to double the atorvastatin dose.

The patient population was: 47% female; 91% Caucasian, 2% Black, 2% Asian, 5% Hispanic, <1% other; 18 to 82 years of age (mean age 61 years).

LIPTRUZET 10/10 was significantly more effective than doubling the dose of atorvastatin to 20 mg in further reducing total-C, LDL-C, TG, and non-HDL-C. Results for HDL-C between the two treatment groups were not significantly different. (See Table 10.) In addition, at Week 4 significantly more patients receiving LIPTRUZET 10/10 attained LDL-C <100 mg/dL (<2.6 mmol/L) compared to those receiving atorvastatin 20 mg, 12% vs. 2%. The baseline mean LDL-C levels for patients receiving LIPTRUZET 10/10 and atorvastatin 20 mg were 186 mg/dL and 187 mg/dL, respectively.

Table 10: Response to LIPTRUZET after 4 Weeks in Patients with CHD or Multiple Cardiovascular Risk Factors and an LDL-C ≥130 mg/dL (Mean * % Change from Baseline †)  Treatment(Daily Dose) N Total-C[Baseline ‡] LDL-C[Baseline ‡] HDL-C[Baseline ‡] TG *[Baseline ‡] Non-HDL-C[Baseline ‡]
* For triglycerides, median % change from baseline
† Patients on atorvastatin 10 mg, then switched to LIPTRUZET 10/10 or titrated to atorvastatin 20 mg
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ p<0.05 for difference with atorvastatin
LIPTRUZET 10/10 305 -17%§[262] -24%§[186] +2%[50.0] -9%§[117] -22%§[212]
Atorvastatin 20 mg 316 -6%[264] -9%[187] +1%[49.9] -4%[119] -8%[214]
For triglycerides, median % change from baseline
† Patients on atorvastatin 10 mg, then switched to LIPTRUZET 10/10 or titrated to atorvastatin 20 mg
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ p<0.05 for difference with atorvastatin
The Titration of Atorvastatin Versus Ezetimibe Add-On to Atorvastatin in Patients with Hypercholesterolemia (TEMPO) study, a multicenter, double-blind, controlled, 6-week study, included 184 patients with an LDL-C level ≥100 mg/dL and ≤160 mg/dL (≥2.6 mmol/L and ≤4.1 mmol/L) and at moderate high risk for coronary heart disease (CHD). All patients received atorvastatin 20 mg for a minimum of 4 weeks prior to randomization. Patients not at the optional NCEP ATP III LDL-C level (<100 mg/dL [<2.6 mmol/L]) were randomized to receive either coadministered ezetimibe and atorvastatin (equivalent to LIPTRUZET 10/20) or atorvastatin 40 mg for 6 weeks.

The patient population was: 45% female; 60% Caucasian, 26% Multi-racial, 6% Black, 8% Asian, <1% American Indian or Alaska native; 24 to 78 years of age (mean age 58 years).

LIPTRUZET 10/20 was significantly more effective than doubling the dose of atorvastatin to 40 mg in further reducing total-C, LDL-C, Apo B and non