. -9%). Results for HDL-C between the two treatment groups were not significantly different. Also, significantly more patients receiving ATOZET 10/40 attained LDL-C <1.8 mmol/L compared to those receiving atorvastatin 80 mg, 74% vs. 32%.
In a placebo-controlled, 8-week study, 308 hypercholesterolemic patients receiving atorvastatin and not at National Cholesterol Education Program (NCEP) LDL-C goal (LDL-C goal based upon baseline LDL-C and CHD risk status) were randomised to receive either ezetimibe 10 mg or placebo in addition to their on-going atorvastatin therapy.
Among patients not at LDL-C goal at baseline (~83%), significantly more patients receiving ezetimibe coadministered with atorvastatin achieved their LDL-C goal compared to patients receiving placebo coadministered with atorvastatin, 67% vs. 19%. Ezetimibe added to atorvastatin therapy lowered LDL-C significantly more than placebo added to atorvastatin therapy, 25% vs. 4%. Ezetimibe added to atorvastatin therapy also significantly decreased total-C, Apo B, and TG compared with placebo added to atorvastatin therapy.
In a controlled, 12-week, 2-phase study, 1539 high-cardiovascular-risk patients, with a LDL-C level between 2.6 and 4.1 mmol/L , on atorvastatin 10 mg daily were randomized to receive: atorvastatin 20 mg, rosuvastatin 10 mg, or ATOZET 10/10. After 6 weeks of treatment (Phase I), patients taking atorvastatin 20 mg who failed to achieve a LDL-C level <2.6 mmol/L were switched to either atorvastatin 40 mg or ATOZET 10/20 for 6 weeks (Phase II), and similar patients taking rosuvastatin 10 mg during Phase I were switched to either rosuvastatin 20 mg or ATOZET 10/20. Reductions in LDL-C and comparisons between the ATOZET group and other treatment groups studied are shown in Table 4.
Table4
Response to ATOZET* in High-Risk Patients with a LDL-C Level Between 2.6 and 4.1 mmol/L on Atorvastatin 10 mg Daily at Baseline
Treatment
N
Percent Change from Baseline†
Total-C
LDL-C
Apo B
TG‡
HDL-C
Non-HDL-C
Phase I
Switched from atorvastatin 10 mg
ATOZET 10/10
120
-13.5
-22.2
-11.3
-6.0
+0.6
-18.3
Atorvastatin 20 mg
480
-6.4§
-9.5§
-6.0¶
-3.9
-1.1
-8.1§
Rosuvastatin 10 mg
939
-7.7§
-13.0§
-6.9#
-1.1
+1.1
-10.6§
Phase II
Switched from atorvastatin 20 mg
ATOZET 10/20
124
-10.7
-17.4
-9.8
-5.9
+0.7
-15.1
Atorvastatin 40 mg
124
-3.8 Þ
-6.9 Þ
-5.4
-3.1
+1.7
-5.8 Þ
Switched from rosuvastatin 10 mg
ATOZET 10/20
231
-11.8
-17.1
-11.9
-10.2
+0.1
-16.2
Rosuvastatin 20 mg
205
-4.5Þ
-7.5 Þ
-4.1Þ
-3.2ß
+0.8
-6.4 Þ
* Coadministered ezetimibe and atorvastatin equivalent to ATOZET 10/10 or ATOZET 10/20
† M-Estimates (based on the method of Huber; 95% CI and p-value were obta |
