To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Condition:	Hypercholesterolemia
Interventions:	Drug: atorvastatin Drug: ezetimibe

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III First Patient In: 4/6/2006; Last Patient Last Visit 2/26/2008 96 centers worldwide (US, Canada) Eligible patients include those on a stable dose of atorvastatin 40 mg; or patients with adjusted LDLC pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients received and were blinded to atorvastatin 40 mg for a 4/5- week run-in period. Patients needed an LDL-C ≥ 70 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 80 mg or addition of ezetimibe 10 mg to their 40 mg dose of atorvastatin for a 6-week treatment period.

	Atorvastatin + Ezetemibe	Atorvastatin
STARTED	288	291
COMPLETED	279	278
NOT COMPLETED	9	13
Adverse Event	4	7
Lost to Follow-up	1	1
Protocol Violation	0	1
Withdrawal by Subject	4	3
Could not take time off work	0	1

	Atorvastatin + Ezetemibe	Atorvastatin	Total
Number of Participants [units: participants]	288	291	579
Age [units: years] Mean ( Full Range )	60.6 ( 31 to 80 )	62 ( 34 to 79 )	61.3 ( 31 to 80 )
Gender [units: participants]
Female	115	113	228
Male	173	178	351
Race/Ethnicity, Customized [units: Participants]
White	237	232	469
Asian	4	8	12
Black	32	29	61
Multi-Racial	15	22	37
Apolipoprotein A-I [units: mg/dL] Mean ± Standard Deviation	154.0 ± 25.5	154.6 ± 25.0	154.3 ± 25.3
Apolipoprotein B [units: mg/dL] Mean ± Standard Deviation	101.3 ± 19.0	102.0 ± 18.8	101.7 ± 18.9
Apolipoprotein B:Apolipoprotein A-I ratio [units: Ratio] Mean ± Standard Deviation	0.7 ± 0.2	0.7 ± 0.2	0.7 ± 0.2
C Reactive Protein [units: mg/dL] Mean ± Standard Deviation	1.8 ± 2.7	1.5 ± 3.0	1.6 ± 2.8
High-Density Lipoprotein [units: mg/dL] Mean ± Standard Deviation	47.4 ± 10.5	47.2 ± 10.6	47.3 ± 10.5
Low-Density Lipoprotein [units: mg/dL] Mean ± Standard Deviation	88.8 ± 16.2	89.8 ± 16.2	89.4 ± 16.2
Low-Density Lipoprotein-C:High-Density Lipoprotein-C ratio [units: Ratio] Mean ± Standard Deviation	2.0 ± 0.6	2.0 ± 0.6	2.0 ± 0.6
Non-High-Density Lipoprotein Cholesterol [units: mg/dL] Mean ± Standard Deviation	117.7 ± 20.8	118.1 ± 21.9	117.9 ± 21.4
Non-High-Density Lipoprotein-C:High-Density Lipoprotein-C ratio [units: Ratio] Mean ± Standard Deviation	2.6 ± 0.8	2.6 ± 0.8	2.6 ± 0.8
Total Cholesterol [units: mg/dL] Mean ± Standard Deviation	165.2 ± 21.4	165.3 ± 22.8	165.2 ± 22.1
Total cholesterol:High-Density Lipoprotein-C ratio [units: Ratio] Mean ± Standard Deviation	3.6 ± 0.8	3.6 ± 0.8	3.6 ± 0.8
Triglycerides [units: mg/dL] Median ± Standard Deviation	132.5 ± 72.1	134.0 ± 72.1	133.5 ± 72.1

Outcome Measures

1. Primary:

Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C [ Baseline and 6 weeks ]

Measure Type	Primary
Measure Title	Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
Measure Description	Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-27.4 ( -29.6 to -25.1 )	-11.0 ( -13.2 to -8.8 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-16.3
Standard Error of the mean	± 1.6
95% Confidence Interval	( -19.4 to -13.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline LDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) [ Baseline and 6 weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
Measure Description	Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C) [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-0.5 ( -1.6 to 0.7 )	-1.0 ( -2.1 to 0.2 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.551
Mean Difference (Final Values) ^[4]	0.5
Standard Error of the mean	± 0.8
95% Confidence Interval	( -1.1 to 2.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline HDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
Measure Description	Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-23.3 ( -25.3 to -21.4 )	-9.0 ( -11.0 to -7.1 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-14.3
Standard Error of the mean	± 1.4
95% Confidence Interval	( -17.1 to -11.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline non-HDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

4. Secondary:

Percent Change From Baseline to Week 6 in Total-Cholesterol [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Total-Cholesterol
Measure Description	Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Total-Cholesterol [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-16.9 ( -18.3 to -15.4 )	-6.9 ( -8.4 to -5.5 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Total-Cholesterol

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-10.0
Standard Error of the mean	± 1.0
95% Confidence Interval	( -12.0 to -7.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline Total-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

5. Secondary:

Percent Change From Baseline to Week 6 in Triglycerides (TG) [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Triglycerides (TG)
Measure Description	Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Triglycerides (TG) [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-12.3 ( -16.3 to -8.2 )	-5.9 ( -10.2 to -0.7 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Triglycerides (TG)

Groups ^[1]	All groups
Method ^[2]	Nonparametric ANCOVA
P Value ^[3]	<0.001
Median Difference (Final Values) ^[4]	-7.3
95% Confidence Interval	( -11.5 to -3.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon’s rank sum test statistic.

6. Secondary:

Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
Measure Description	Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	275	276
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B) [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-17.8 ( -19.6 to -16.0 )	-7.7 ( -9.5 to -5.8 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-10.1
Standard Error of the mean	± 1.3
95% Confidence Interval	( -12.7 to -7.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline Apo B value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

7. Secondary:

Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
Measure Description	Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	275	276
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I) [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-0.3 ( -1.5 to 0.9 )	-1.2 ( -2.3 to -0.0 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.313
Mean Difference (Final Values) ^[4]	0.9
Standard Error of the mean	± 0.8
95% Confidence Interval	( -0.8 to 2.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline Apo A-I value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

8. Secondary:

Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
Measure Description	Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-16.0 ( -176.6 to -14.4 )	-5.6 ( -7.2 to -4.1 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-10.4
Standard Error of the mean	± 1.1
95% Confidence Interval	( -12.6 to -8.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline Total-C:HDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
Measure Description	Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio [units: Percent change] Least Squares Mean ( 95% Confidence Interval )	-26.4 ( -28.8 to -24.0 )	-9.9 ( -12.3 to -7.5 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-16.5
Standard Error of the mean	± 1.7
95% Confidence Interval	( -19.9 to -13.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline LDL-C:HDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

10. Secondary:

Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
Measure Description	Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	275	276
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-16.9 ( -18.9 to -14.9 )	-5.9 ( -7.9 to -3.9 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-11.0
Standard Error of the mean	± 1.4
95% Confidence Interval	( -13.8 to -8.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline Apo B:Apo A-I value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

11. Secondary:

Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
Measure Description	Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-22.2 ( -24.5 to -19.9 )	-7.6 ( -9.9 to -5.4 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	-14.5
Standard Error of the mean	± -1.6
95% Confidence Interval	( -17.7 to -11.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline non-HDL-C:HDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

12. Secondary:

Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) [ Baseline and 6 Weeks ]

Measure Type	Secondary
Measure Title	Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
Measure Description	Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%
Time Frame	Baseline and 6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	276
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP) [units: Percent Change] Least Squares Mean ( 95% Confidence Interval )	-18.3 ( -25.0 to -11.1 )	-11.5 ( -18.7 to -3.6 )

Statistical Analysis 1 for Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)

Groups ^[1]	All groups
Method ^[2]	Longitudinal Data Analysis (LDA)
P Value ^[3]	0.174
Mean Difference (Final Values) ^[4]	-6.8
95% Confidence Interval	( -17.1 to 3.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.

13. Secondary:

Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 [ 6 Weeks ]

Measure Type	Secondary
Measure Title	Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
Measure Description	No text entered.
Time Frame	6 Weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Measured Values

	Atorvastatin + Ezetemibe	Atorvastatin
Number of Participants Analyzed [units: participants]	277	279
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6 [units: Participants]
<70 mg/dL	204	88
>=70 mg/dL	73	191

Statistical Analysis 1 for Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6

Groups ^[1]	All groups
Method ^[2]	Regression, Logistic
P Value ^[3]	<0.001
Odds Ratio (OR) ^[4]	8.37
95% Confidence Interval	( 5.45 to 12.84 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Model terms: treatment and baseline LDL-C value
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_105, MK0653-090
Study First Received:	January 11, 2006
Results First Received:	February 6, 2009
Last Updated:	October 23, 2009
ClinicalTrials.gov Identifier:	NCT00276484 History of Changes
Health Authority:	United States: Food and Drug Administration