;LDL-C
Apo B
TGa
HDL-C
Non-HDL-C
Pooled data (All ATOZET doses)c
255
-41
-56
-45
-33
+7
-52
Pooled data (All atorvastatin doses)c
248
-32
-44
-36
-24
+4
-41
Ezetimibe 10 mg
65
-14
-20
-15
-5
+4
-18
Placebo
60
+4
+4
+3
-6
+4
+4
ATOZET by dose
10/10
65
-38
-53
-43
-31
+9
-49
10/20
62
-39
-54
-44
-30
+9
-50
10/40
65
-42
-56
-45
-34
+5
-52
10/80
63
-46
-61
-50
-40
+7
-58
Atorvastatin by dose
10 mg
60
-26
-37
-28
-21
+6
-34
20 mg
60
-30
-42
-34
-23
+4
-39
40 mg
66
-32
-45
-37
-24
+4
-41
80 mg
62
-40
-54
-46
-31
+3
-51
a For triglycerides, median % change from baseline
b Baseline - on no lipid-lowering medicinal product
c ATOZET pooled (10/10-10/80 mg) 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).
In a controlled study, the Titration of Atorvastatin Versus Ezetimibe Add-On to Atorvastatin in Patients with Hypercholesterolaemia (TEMPO) study, 184 patients, with an LDL-C level ≥2.6 mmol/L and ≤4.1 mmol/L and at moderate high risk for CHD, received atorvastatin 20 mg for a minimum of 4 weeks prior to randomisation. Patients not at an LDL-C level <2.6 mmol/L were randomised to receive either coadministered ezetimibe and atorvastatin (equivalent to ATOZET 10/20) or atorvastatin 40 mg for 6 weeks.
ATOZET 10/20 was significantly more effective than doubling the dose of atorvastatin to 40 mg in further reducing total-C (-20% vs. -7%), LDL-C (-31% vs. -11%), Apo B (-21% vs. -8%), and non-HDL-C (-27% vs. -10%). Results for HDL-C and TG between the two treatment groups were not significantly different. Also, significantly more patients receiving ATOZET 10/20 attained LDL-C <2.6 mmol/L compared to those receiving atorvastatin 40 mg, 84% vs. 49%.
In a controlled study, The Ezetimibe Plus Atorvastatin Versus Atorvastatin Titration in Achieving Lower LDL-C Targets in Hypercholesterolaemic Patients (EZ-PATH) study, 556 high-cardiovascular-risk patients with a LDL-C level ≥1.8 mmol/L and ≤4.1 mmol/L received atorvastatin 40 mg for a minimum of 4 weeks prior to randomisation. Patients not at a LDL-C level <1.8 mmol/L were randomised to receive either coadministered ezetimibe and atorvastatin (equivalent to ATOZET 10/40) or atorvastatin 80 mg for 6 weeks.
ATOZET 10/40 was significantly more effective than doubling the dose of atorvastatin to 80 mg in further reducing total-C (-17% vs. -7%), LDL-C (-27% vs. -11%), Apo B (-18% vs. -8%), TG (-12% vs. -6%), and non-HDL-C (-23% vs |
