lent 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]
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-HDL-C. Results for HDL-C and TG between the two treatment groups were not significantly different. (See Table 11.) In addition, significantly more patients receiving LIPTRUZET 10/20 attained LDL-C <100 mg/dL (<2.6 mmol/L) compared to those receiving atorvastatin 40 mg, 84% vs. 49%.
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 10/2 |
