AT GOAL: Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00540293
• Collaborator: (none)
• Enrollment: 425
• Locations: 20
• Arm: 1
• Duration (Months): 7
• Patients Per Site: 21.3
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias	Drug: Atorvastatin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 425 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Eight-Week Treatment, Single-Step Titration Open-Label Study Assessing The Percentage Of Korean Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 MG, 20 MG, And 40 MG.
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group this patient group consists of dyslipidemia patients with various CVD risk factors	Drug: Atorvastatin; Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group

Outcome Measures

Primary Outcome Measures

1. Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment. [Week 8]

   LDL-C Responders by visit and by risk group - full analysis set (FAS)

Secondary Outcome Measures

1. Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment. [Week 4]

   LDL-C Responders by visit and by risk group - FAS

2. Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment [Weeks 4 and 8]

   Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride

3. Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment [weeks 4 and 8]

   Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride

4. Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [8 weeks]

   LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)

5. Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin. [8 weeks]

   LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)

6. Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment [4 and 8 weeks]

   Median baseline, and change from baseline in hs-CRP by risk group - FAS

7. Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment [4 and 8 weeks]

   Percent change from baseline in hs-CRP by risk group - FAS

8. Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [Baseline, and 8 weeks]

   Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS

9. Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment. [8 weeks]

   Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Is a Korean , dyslipidemic outpatient

2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk < 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk > 20 %)

3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline

Exclusion Criteria:

1. Is pregnant or lactating

2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis

3. Has history of intolerance or hypersensitivity to atorvastatin or other statins

4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)

5. Has HbAlc > 10%

6. Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Daegu	Korea	Korea, Republic of	705-717
2	Pfizer Investigational Site	Seoul	Korea	Korea, Republic of	135-710
3	Pfizer Investigational Site	Busan		Korea, Republic of	602-739
4	Pfizer Investigational Site	Busan		Korea, Republic of	614-735
5	Pfizer Investigational Site	Daegu		Korea, Republic of	700-712
6	Pfizer Investigational Site	Daejeon		Korea, Republic of	302-718
7	Pfizer Investigational Site	Gwangju		Korea, Republic of	501-757
8	Pfizer Investigational Site	Gwangju		Korea, Republic of	503-715
9	Pfizer Investigational Site	Gyeonggi-do		Korea, Republic of	431-070
10	Pfizer Investigational Site	Gyeonggi-do		Korea, Republic of	463-707
11	Pfizer Investigational Site	Incheon		Korea, Republic of	405-760
12	Pfizer Investigational Site	Kyunggi-do		Korea, Republic of	420-717
13	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
14	Pfizer Investigational Site	Seoul		Korea, Republic of	110-746
15	Pfizer Investigational Site	Seoul		Korea, Republic of	120-752
16	Pfizer Investigational Site	Seoul		Korea, Republic of	134-010
17	Pfizer Investigational Site	Seoul		Korea, Republic of	136-705
18	Pfizer Investigational Site	Seoul		Korea, Republic of	137-701
19	Pfizer Investigational Site	Seoul		Korea, Republic of	138-736
20	Pfizer Investigational Site	Seoul		Korea, Republic of	143-914

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00540293
• Other Study ID Numbers: A2581157
• First Posted: Oct 8, 2007
• Last Update Posted: Mar 12, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Dyslipidemias; Atorvastatin

Study Results

Participant Flow

Recruitment Details	Study was conducted at 20 centers in Korea
Pre-assignment Detail	Participants who were on antilipidemic medications at the time of screening required a 6-week washout period prior to study treatment

Arm/Group Title	Total Treatment Group (All Subjects Who Received Atorvastatin)
Arm/Group Description	this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
Period Title: Overall Study
STARTED	425
COMPLETED	390
NOT COMPLETED	35

Baseline Characteristics

Arm/Group Title	Total Treatment Group (All Subjects Who Received Atorvastatin)
Arm/Group Description	this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
Overall Participants	425
Age (Years) [Mean (Standard Deviation) ]
Females between 18 and 80 years	62.9 (8.6)
Males between 18 and 80 years	58.6 (10.2)
Sex: Female, Male (Count of Participants)
Female	195 45.9%
Male	230 54.1%

Outcome Measures

1. Secondary Outcome

Title	Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
Description	LDL-C Responders by visit and by risk group - FAS
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
Mean (95% Confidence Interval) [Percent subjects achieved LDL-C target]	81.9	85.7	95.5	79.9

2. Secondary Outcome

Title	Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Description	Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Time Frame	Weeks 4 and 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
LDL-C baseline	151.7	187.0	160.6	147.7
LDL-C (week 4)	-63.5	-73.8	-65.1	-62.4
LDL-C (week 8)	-65.3	-77.6	-64.2	-64.4
HDL-C baseline	48.3	50.5	48.0	48.2
HDL-C (week 4)	0.1	-0.8	3.3	-0.2
HDL-C (week 8)	0.5	2.1	3.0	0.0
Non-HDL-C baseline	175.5	209.9	187.1	171.1
Non-HDL-C (week 4)	-69.4	-75.4	-71.3	-68.6
Non-HDL-C (week 8)	-70.7	-80.9	-72.1	-69.7
LDL-C/HDL-C ratio baseline	3.2	3.7	3.4	3.2
LDL-C/HDL-C Ratio (Scalar) week 4	-1.4	-1.4	-1.5	-1.3
LDL-C/HDL-C Ratio (Scalar) week 8	-1.4	-1.6	-1.5	-1.4
TC baseline	223.9	262.3	235.1	219.3
TC (week 4)	-69.4	-78.2	-68.0	-68.8
TC (week 8)	-70.4	-80.7	-69.1	-69.7
TG baseline	154.1	150.7	152.3	154.7
TG (week 4)	-29.1	-11.5	-16.6	-32.1
TG (week 8)	-29.3	-20.9	-18.5	-31.4

3. Secondary Outcome

Title	Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Description	Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Time Frame	weeks 4 and 8

Outcome Measure Data

Analysis Population Description

Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
LDL-C % change from baseline (week 4)	-40.9	-39.5	-39.6	-41.2
LDL-C % change from baseline (week 8)	-42.0	-41.2	-39.3	-42.5
HDL-C % change from baseline (week 4)	1.7	-0.2	7.7	1.1
HDL-C % change from baseline (week 8)	2.6	5.6	6.7	1.8
Non-HDL-C % change from baseline (week 4)	-38.7	-35.5	-37.7	-39.1
Non-HDL-C % change from baseline (week 8)	-39.4	-38.2	-38.3	-39.7
LDL-C/HDL-C ratio % change from baseline (week 4)	-41.3	-36.7	-44.1	-41.4
LDL-C/HDL-C ratio % change from baseline (week 8)	-42.6	-41.6	-42.9	-42.6
TC % change from baseline (week 4)	-30.3	-29.7	-28.5	-30.6
TC % change from baseline (week 8)	-30.7	-30.4	-29.2	-31.0
TG % change from baseline (week 4)	-8.2	4.4	-8.3	-9.3
TG % change from baseline (week 8)	-9.8	-6.3	-7.0	-10.5

4. Secondary Outcome

Title	Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
Description	LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
FAS population responders no titration	339 79.8%	24 NaN	41 NaN	274 NaN
FAS population responders 1-step titration	56 13.2%	3 NaN	1 NaN	52 NaN
EVAL population responders no titration	305 71.8%	22 NaN	39 NaN	244 NaN
EVAL population responders 1-step titration	53 12.5%	3 NaN	1 NaN	49 NaN
FAS population (no LOCF) no titration	336 79.1%	24 NaN	41 NaN	271 NaN
FAS population (no LOCF) 1-step titration	56 13.2%	3 NaN	1 NaN	52 NaN

5. Secondary Outcome

Title	Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
Description	LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
FAS population, no titration	89.1 21%	95.8 NaN	97.6 NaN	87.2 NaN
FAS population, 1-step titration	82.1 19.3%	100.0 NaN	100.0 NaN	80.8 NaN
EVAL population, no titration	91.1 21.4%	95.5 NaN	97.4 NaN	89.8 NaN
EVAL population, 1-step titration	83.0 19.5%	100.0 NaN	100.0 NaN	81.6 NaN
FAS population (no LOCF), no titration	89.0 20.9%	95.8 NaN	97.6 NaN	87.1 NaN
FAS population (no LOCF), 1-step titration	82.1 19.3%	100.0 NaN	100.0 NaN	80.8 NaN

6. Secondary Outcome

Title	Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Description	Median baseline, and change from baseline in hs-CRP by risk group - FAS
Time Frame	4 and 8 weeks

Outcome Measure Data

Analysis Population Description

Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
Baseline	0.108	0.082	0.075	0.122
Median change from baseline (week 4)	-0.008	-0.008	-0.002	-0.010
Median change from baseline (week 8)	-0.015	-0.011	-0.001	-0.018

7. Primary Outcome

Title	Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
Description	LDL-C Responders by visit and by risk group - full analysis set (FAS)
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total: sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
Mean (95% Confidence Interval) [Percentage of participants]	86.0 20.2%	92.9 NaN	95.5 NaN	84.3 NaN

8. Secondary Outcome

Title	Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Description	Percent change from baseline in hs-CRP by risk group - FAS
Time Frame	4 and 8 weeks

Outcome Measure Data

Analysis Population Description

Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	415	28	44	343
Median % change from baseline (week 4)	-12.346	-13.941	-2.553	-16.197
Median % change from baseline (week 8)	-18.605	-18.621	-1.472	-20.561

9. Secondary Outcome

Title	Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Description	Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Time Frame	Baseline, and 8 weeks

Outcome Measure Data

Analysis Population Description

Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	408	28	43	337
MCP-1 baseline	302.7	305.2	317.7	301.6
MCP-1 change from baseline (week 8)	39.8	-15.0	-22.4	59.4
IL-6 baseline	0.40	0.30	0.40	0.50
IL-6 change from baseline (week 8)	0.00	0.00	-0.10	0.00
TNF-alpha baseline	0.10	0.10	0.20	0.10
TNF-alpha change from baseline (week 8)	0.00	0.00	0.00	0.00

10. Secondary Outcome

Title	Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
Description	Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).

Arm/Group Title	Total	Low Risk	Medium Risk	High Risk
Arm/Group Description	N=425 (Total=sum of all risk groups)	N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)	N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)	N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
Measure Participants	408	28	43	337
MCP-1 % change (week 8)	14.0	-5.6	-8.0	18.2
IL-6 % change (week 8)	0.00	0.00	-12.50	0.00
TNF-alpha % change (week 8)	0.00	0.00	0.00	0.00

Adverse Events

Arm/Group Title	Total Treatment Group (All Subjects Who Received Atorvastatin)
Arm/Group Description	this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
All Cause Mortality
	Total Treatment Group (All Subjects Who Received Atorvastatin)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Total Treatment Group (All Subjects Who Received Atorvastatin)
	Affected / at Risk (%)	# Events
Total	3/ (NaN)
Injury, poisoning and procedural complications
Wrist fracture	1/425 (0.2%)
Nervous system disorders
Cerabral infarction	2/425 (0.5%)
Other (Not Including Serious) Adverse Events
	Total Treatment Group (All Subjects Who Received Atorvastatin)
	Affected / at Risk (%)	# Events
Total	14/ (NaN)
Infections and infestations
Nasopharyngitis	8/425 (1.9%)
Nervous system disorders
Headache	6/425 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.