Table 11: Response to LIPTRUZET in Patients with Primary Hypercholesterolemia (Mean * % Change from Baseline †)  Treatment(Daily Dose) N Total-C[Baseline ‡] LDL-C[Baseline ‡] Apo B[Baseline ‡] HDL-C[Baseline ‡] TG *[Baseline ‡] Non-HDL-C[Baseline ‡]
* For triglycerides, median % change from baseline
† Patients on atorvastatin 20 mg, then switched to LIPTRUZET 10/20 or titrated to atorvastatin 40 mg
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ p<0.05 for difference with atorvastatin
LIPTRUZET 10/20 92 -20%§[203] -31%§[120] -21%§[123] +3%[50.9] -18%[155] -27%§[152]
Atorvastatin 40 mg 92 -7%[201] -11%[118] -8%[120] +1%[52.1] -6%[148] -10%[149]

For triglycerides, median % change from baseline
† Patients on atorvastatin 20 mg, then switched to LIPTRUZET 10/20 or titrated to atorvastatin 40 mg
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ p<0.05 for difference with atorvastatin
The Ezetimibe Plus Atorvastatin Versus Atorvastatin Titration in Achieving Lower LDL-C Targets in Hypercholesterolemic Patients (EZ-PATH) study, a multicenter, double-blind, controlled, 6-week study, included 556 patients with an LDL-C level ≥70 mg/dL and ≤160 mg/dL (≥1.8 mmol/L and ≤4.1 mmol/L) and at high risk for coronary heart disease (CHD). All patients received atorvastatin 40 mg for a minimum of 4 weeks prior to randomization. Patients not at the optional NCEP ATP III LDL-C level <70 mg/dL (<1.8 mmol/L) were randomized to receive either coadministered ezetimibe and atorvastatin (equivalent to LIPTRUZET 10/40) or atorvastatin 80 mg for 6 weeks.

The patient population was: 39% female; 81% Caucasian, 11% Black, 6% Multi-racial, 2% Asian; 31 to 80 years of age (mean age 52 years).

LIPTRUZET 10/40 was significantly more effective than doubling the dose of atorvastatin to 80 mg in further reducing total-C, LDL-C, Apo B, TG, and non-HDL-C. Results for HDL-C between the two treatment groups were not significantly different. (See Table 12.) In addition, significantly more patients receiving LIPTRUZET 10/40 attained LDL-C <70 mg/dL (<1.8 mmol/L) compared to those receiving atorvastatin 80 mg, 74% vs. 32%.
Table 12: Response to LIPTRUZET in Patients with Primary Hypercholesterolemia (Mean * % Change from Baseline †)  Treatment(Daily Dose) N Total-C[Baseline ‡] LDL-C[Baseline ‡] Apo B[Baseline ‡] HDL-C[Baseline ‡] TG *[Baseline ‡] Non-HDL-C[Baseline ‡]
* For triglycerides, median % change from baseline
† Patients on atorvastatin 20 mg, then switched to LIPTRUZET 10/40 or titrated to atorvastatin 80 mg
‡ Baseline units: mg/dL; medians for TG, means for all other values
§ p<0.05 for difference with atorvastatin
LIPTRUZET 10/40 277 -17%§[165] -27%§[89] -18%§[101] 0%[47.7] -12%§[131] -23%§[117]
Atorvastatin 80 mg 279 -7%[165] -11%[90] -8%[102] -1%[46.9] -6%[136] -9%[118]

For triglycerides, median %