Trial Outcomes & Findings for Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study (NCT NCT00540293)
NCT ID: NCT00540293
Last Updated: 2021-03-12
Results Overview
LDL-C Responders by visit and by risk group - full analysis set (FAS)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
425 participants
Primary outcome timeframe
Week 8
Results posted on
2021-03-12
Participant Flow
Study was conducted at 20 centers in Korea
Participants who were on antilipidemic medications at the time of screening required a 6-week washout period prior to study treatment
Participant milestones
| Measure |
Total Treatment Group (All Subjects Who Received Atorvastatin)
this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
|
|---|---|
|
Overall Study
STARTED
|
425
|
|
Overall Study
COMPLETED
|
390
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Total Treatment Group (All Subjects Who Received Atorvastatin)
this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
|
|---|---|
|
Overall Study
Adverse event related to study drug
|
10
|
|
Overall Study
Adverse event not related to study drug
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Protocol violation, & subject schedule
|
12
|
Baseline Characteristics
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
Baseline characteristics by cohort
| Measure |
Total Treatment Group (All Subjects Who Received Atorvastatin)
n=425 Participants
this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
|
|---|---|
|
Age, Continuous
Females between 18 and 80 years
|
62.9 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Age, Continuous
Males between 18 and 80 years
|
58.6 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: 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)
LDL-C Responders by visit and by risk group - full analysis set (FAS)
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.
|
86.0 Percentage of participants
Interval 82.3 to 89.2
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
95.5 Percentage of participants
Interval 84.5 to 99.4
|
84.3 Percentage of participants
Interval 80.0 to 87.9
|
SECONDARY outcome
Timeframe: Week 4LDL-C Responders by visit and by risk group - FAS
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.
|
81.9 Percent subjects achieved LDL-C target
Interval 77.9 to 85.5
|
85.7 Percent subjects achieved LDL-C target
Interval 67.3 to 96.0
|
95.5 Percent subjects achieved LDL-C target
Interval 84.5 to 99.4
|
79.9 Percent subjects achieved LDL-C target
Interval 75.2 to 84.0
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Mean 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
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
LDL-C (week 4)
|
-63.5 mg/dL (ratio for Scalar)
Interval -66.2 to -60.8
|
-73.8 mg/dL (ratio for Scalar)
Interval -82.7 to -64.8
|
-65.1 mg/dL (ratio for Scalar)
Interval -73.5 to -56.7
|
-62.4 mg/dL (ratio for Scalar)
Interval -65.4 to -59.4
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
HDL-C (week 4)
|
0.1 mg/dL (ratio for Scalar)
Interval -0.7 to 0.9
|
-0.8 mg/dL (ratio for Scalar)
Interval -3.6 to 2.0
|
3.3 mg/dL (ratio for Scalar)
Interval 0.9 to 5.7
|
-0.2 mg/dL (ratio for Scalar)
Interval -1.1 to 0.7
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
LDL-C baseline
|
151.7 mg/dL (ratio for Scalar)
Interval 149.1 to 154.4
|
187.0 mg/dL (ratio for Scalar)
Interval 179.8 to 194.1
|
160.6 mg/dL (ratio for Scalar)
Interval 154.3 to 167.0
|
147.7 mg/dL (ratio for Scalar)
Interval 144.9 to 150.5
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
LDL-C (week 8)
|
-65.3 mg/dL (ratio for Scalar)
Interval -68.0 to -62.5
|
-77.6 mg/dL (ratio for Scalar)
Interval -88.3 to -66.9
|
-64.2 mg/dL (ratio for Scalar)
Interval -72.4 to -56.0
|
-64.4 mg/dL (ratio for Scalar)
Interval -67.4 to -61.4
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
HDL-C baseline
|
48.3 mg/dL (ratio for Scalar)
Interval 47.3 to 49.3
|
50.5 mg/dL (ratio for Scalar)
Interval 47.4 to 53.7
|
48.0 mg/dL (ratio for Scalar)
Interval 45.5 to 50.5
|
48.2 mg/dL (ratio for Scalar)
Interval 47.0 to 49.3
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
HDL-C (week 8)
|
0.5 mg/dL (ratio for Scalar)
Interval -0.4 to 1.3
|
2.1 mg/dL (ratio for Scalar)
Interval -1.6 to 5.9
|
3.0 mg/dL (ratio for Scalar)
Interval 0.9 to 5.1
|
0.0 mg/dL (ratio for Scalar)
Interval -1.0 to 1.0
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Non-HDL-C baseline
|
175.5 mg/dL (ratio for Scalar)
Interval 172.5 to 178.5
|
209.9 mg/dL (ratio for Scalar)
Interval 201.0 to 218.8
|
187.1 mg/dL (ratio for Scalar)
Interval 179.9 to 194.4
|
171.1 mg/dL (ratio for Scalar)
Interval 167.9 to 174.4
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Non-HDL-C (week 4)
|
-69.4 mg/dL (ratio for Scalar)
Interval -72.3 to -66.5
|
-75.4 mg/dL (ratio for Scalar)
Interval -87.8 to -63.1
|
-71.3 mg/dL (ratio for Scalar)
Interval -80.2 to -62.5
|
-68.6 mg/dL (ratio for Scalar)
Interval -71.8 to -65.4
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
Non-HDL-C (week 8)
|
-70.7 mg/dL (ratio for Scalar)
Interval -73.7 to -67.7
|
-80.9 mg/dL (ratio for Scalar)
Interval -93.9 to -67.8
|
-72.1 mg/dL (ratio for Scalar)
Interval -80.3 to -64.0
|
-69.7 mg/dL (ratio for Scalar)
Interval -73.0 to -66.4
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
LDL-C/HDL-C ratio baseline
|
3.2 mg/dL (ratio for Scalar)
Interval 3.1 to 3.3
|
3.7 mg/dL (ratio for Scalar)
Interval 3.4 to 4.0
|
3.4 mg/dL (ratio for Scalar)
Interval 3.2 to 3.6
|
3.2 mg/dL (ratio for Scalar)
Interval 3.1 to 3.3
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
LDL-C/HDL-C Ratio (Scalar) week 4
|
-1.4 mg/dL (ratio for Scalar)
Interval -1.4 to -1.3
|
-1.4 mg/dL (ratio for Scalar)
Interval -1.7 to -1.1
|
-1.5 mg/dL (ratio for Scalar)
Interval -1.7 to -1.3
|
-1.3 mg/dL (ratio for Scalar)
Interval -1.4 to -1.3
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
LDL-C/HDL-C Ratio (Scalar) week 8
|
-1.4 mg/dL (ratio for Scalar)
Interval -1.5 to -1.3
|
-1.6 mg/dL (ratio for Scalar)
Interval -1.9 to -1.2
|
-1.5 mg/dL (ratio for Scalar)
Interval -1.7 to -1.3
|
-1.4 mg/dL (ratio for Scalar)
Interval -1.5 to -1.3
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
TC baseline
|
223.9 mg/dL (ratio for Scalar)
Interval 220.8 to 227.0
|
262.3 mg/dL (ratio for Scalar)
Interval 253.9 to 270.8
|
235.1 mg/dL (ratio for Scalar)
Interval 228.0 to 242.3
|
219.3 mg/dL (ratio for Scalar)
Interval 216.0 to 222.6
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
TC (week 4)
|
-69.4 mg/dL (ratio for Scalar)
Interval -72.4 to -66.4
|
-78.2 mg/dL (ratio for Scalar)
Interval -89.3 to -67.1
|
-68.0 mg/dL (ratio for Scalar)
Interval -77.2 to -58.8
|
-68.8 mg/dL (ratio for Scalar)
Interval -72.2 to -65.5
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
TC (week 8)
|
-70.4 mg/dL (ratio for Scalar)
Interval -73.4 to -67.3
|
-80.7 mg/dL (ratio for Scalar)
Interval -94.2 to -67.3
|
-69.1 mg/dL (ratio for Scalar)
Interval -77.2 to -61.1
|
-69.7 mg/dL (ratio for Scalar)
Interval -73.1 to -66.2
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
TG baseline
|
154.1 mg/dL (ratio for Scalar)
Interval 146.2 to 162.1
|
150.7 mg/dL (ratio for Scalar)
Interval 128.6 to 172.8
|
152.3 mg/dL (ratio for Scalar)
Interval 130.3 to 174.2
|
154.7 mg/dL (ratio for Scalar)
Interval 145.6 to 163.7
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
TG (week 4)
|
-29.1 mg/dL (ratio for Scalar)
Interval -35.5 to -22.7
|
-11.5 mg/dL (ratio for Scalar)
Interval -43.0 to 20.0
|
-16.6 mg/dL (ratio for Scalar)
Interval -31.4 to -1.8
|
-32.1 mg/dL (ratio for Scalar)
Interval -39.2 to -25.1
|
|
Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment
TG (week 8)
|
-29.3 mg/dL (ratio for Scalar)
Interval -37.9 to -20.7
|
-20.9 mg/dL (ratio for Scalar)
Interval -51.3 to 9.5
|
-18.5 mg/dL (ratio for Scalar)
Interval -36.3 to -0.7
|
-31.4 mg/dL (ratio for Scalar)
Interval -41.3 to -21.5
|
SECONDARY outcome
Timeframe: weeks 4 and 8Population: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
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
TG % change from baseline (week 4)
|
-8.2 Percent
Interval -12.9 to -3.6
|
4.4 Percent
Interval -18.5 to 27.3
|
-8.3 Percent
Interval -17.7 to 1.2
|
-9.3 Percent
Interval -14.4 to -4.1
|
|
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
TG % change from baseline (week 8)
|
-9.8 Percent
Interval -14.9 to -4.8
|
-6.3 Percent
Interval -27.0 to 14.5
|
-7.0 Percent
Interval -20.4 to 6.4
|
-10.5 Percent
Interval -16.2 to -4.8
|
|
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
LDL-C % change from baseline (week 4)
|
-40.9 Percent
Interval -42.3 to -39.5
|
-39.5 Percent
Interval -44.1 to -35.0
|
-39.6 Percent
Interval -43.8 to -35.5
|
-41.2 Percent
Interval -42.8 to -39.6
|
|
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
LDL-C % change from baseline (week 8)
|
-42.0 Percent
Interval -43.4 to -40.7
|
-41.2 Percent
Interval -46.6 to -35.8
|
-39.3 Percent
Interval -43.5 to -35.1
|
-42.5 Percent
Interval -44.0 to -41.0
|
|
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
HDL-C % change from baseline (week 4)
|
1.7 Percent
Interval 0.0 to 3.4
|
-0.2 Percent
Interval -6.0 to 5.6
|
7.7 Percent
Interval 2.3 to 13.1
|
1.1 Percent
Interval -0.8 to 2.9
|
|
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
HDL-C % change from baseline (week 8)
|
2.6 Percent
Interval 0.8 to 4.4
|
5.6 Percent
Interval -2.1 to 13.2
|
6.7 Percent
Interval 2.3 to 11.1
|
1.8 Percent
Interval -0.2 to 3.9
|
|
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
Non-HDL-C % change from baseline (week 4)
|
-38.7 Percent
Interval -40.1 to -37.4
|
-35.5 Percent
Interval -40.9 to -30.1
|
-37.7 Percent
Interval -41.5 to -33.8
|
-39.1 Percent
Interval -40.6 to -37.7
|
|
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
Non-HDL-C % change from baseline (week 8)
|
-39.4 Percent
Interval -40.7 to -38.1
|
-38.2 Percent
Interval -44.1 to -32.2
|
-38.3 Percent
Interval -42.1 to -34.5
|
-39.7 Percent
Interval -41.1 to -38.2
|
|
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
LDL-C/HDL-C ratio % change from baseline (week 4)
|
-41.3 Percent
Interval -43.0 to -39.7
|
-36.7 Percent
Interval -44.3 to -29.0
|
-44.1 Percent
Interval -48.9 to -39.3
|
-41.4 Percent
Interval -43.2 to -39.6
|
|
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
LDL-C/HDL-C ratio % change from baseline (week 8)
|
-42.6 Percent
Interval -44.3 to -40.9
|
-41.6 Percent
Interval -49.5 to -33.7
|
-42.9 Percent
Interval -48.0 to -37.7
|
-42.6 Percent
Interval -44.5 to -40.8
|
|
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
TC % change from baseline (week 4)
|
-30.3 Percent
Interval -31.4 to -29.2
|
-29.7 Percent
Interval -33.6 to -25.7
|
-28.5 Percent
Interval -31.9 to -25.2
|
-30.6 Percent
Interval -31.9 to -29.3
|
|
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
TC % change from baseline (week 8)
|
-30.7 Percent
Interval -31.9 to -29.6
|
-30.4 Percent
Interval -35.2 to -25.5
|
-29.2 Percent
Interval -32.3 to -26.2
|
-31.0 Percent
Interval -32.2 to -29.7
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population responders no titration
|
339 Participants
|
24 Participants
|
41 Participants
|
274 Participants
|
|
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population (no LOCF) no titration
|
336 Participants
|
24 Participants
|
41 Participants
|
271 Participants
|
|
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population responders 1-step titration
|
56 Participants
|
3 Participants
|
1 Participants
|
52 Participants
|
|
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
EVAL population responders no titration
|
305 Participants
|
22 Participants
|
39 Participants
|
244 Participants
|
|
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
EVAL population responders 1-step titration
|
53 Participants
|
3 Participants
|
1 Participants
|
49 Participants
|
|
Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population (no LOCF) 1-step titration
|
56 Participants
|
3 Participants
|
1 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population, no titration
|
89.1 percentage of participants
Interval 85.3 to 92.2
|
95.8 percentage of participants
Interval 78.9 to 99.9
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
87.2 percentage of participants
Interval 82.7 to 90.9
|
|
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population, 1-step titration
|
82.1 percentage of participants
Interval 69.6 to 91.1
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
80.8 percentage of participants
Interval 67.5 to 90.4
|
|
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
EVAL population, no titration
|
91.1 percentage of participants
Interval 87.4 to 94.1
|
95.5 percentage of participants
Interval 77.2 to 99.9
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
89.8 percentage of participants
Interval 85.2 to 93.3
|
|
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
EVAL population, 1-step titration
|
83.0 percentage of participants
Interval 70.2 to 91.9
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
81.6 percentage of participants
Interval 68.0 to 91.2
|
|
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population (no LOCF), no titration
|
89.0 percentage of participants
Interval 85.1 to 92.1
|
95.8 percentage of participants
Interval 78.9 to 99.9
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
87.1 percentage of participants
Interval 82.5 to 90.8
|
|
Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.
FAS population (no LOCF), 1-step titration
|
82.1 percentage of participants
Interval 69.6 to 91.1
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
80.8 percentage of participants
Interval 67.5 to 90.4
|
SECONDARY outcome
Timeframe: 4 and 8 weeksPopulation: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
Median baseline, and change from baseline in hs-CRP by risk group - FAS
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Baseline
|
0.108 mg/dL
Interval 0.094 to 0.126
|
0.082 mg/dL
Interval 0.06 to 0.112
|
0.075 mg/dL
Interval 0.059 to 0.126
|
0.122 mg/dL
Interval 0.102 to 0.137
|
|
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Median change from baseline (week 4)
|
-0.008 mg/dL
Interval -0.014 to -0.005
|
-0.008 mg/dL
Interval -0.028 to -0.001
|
-0.002 mg/dL
Interval -0.014 to 0.023
|
-0.010 mg/dL
Interval -0.018 to -0.005
|
|
Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Median change from baseline (week 8)
|
-0.015 mg/dL
Interval -0.021 to -0.009
|
-0.011 mg/dL
Interval -0.034 to 0.018
|
-0.001 mg/dL
Interval -0.021 to 0.01
|
-0.018 mg/dL
Interval -0.027 to -0.01
|
SECONDARY outcome
Timeframe: 4 and 8 weeksPopulation: Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).
Percent change from baseline in hs-CRP by risk group - FAS
Outcome measures
| Measure |
Total
n=415 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=44 Participants
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.)
|
High Risk
n=343 Participants
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.)
|
|---|---|---|---|---|
|
Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Median % change from baseline (week 4)
|
-12.346 percentage
Interval -21.429 to -4.651
|
-13.941 percentage
Interval -35.055 to -1.923
|
-2.553 percentage
Interval -22.951 to 25.926
|
-16.197 percentage
Interval -24.182 to -4.523
|
|
Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment
Median % change from baseline (week 8)
|
-18.605 percentage
Interval -24.138 to -11.111
|
-18.621 percentage
Interval -37.363 to 20.69
|
-1.472 percentage
Interval -26.364 to 14.925
|
-20.561 percentage
Interval -25.333 to -12.346
|
SECONDARY outcome
Timeframe: Baseline, and 8 weeksPopulation: Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).
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
Outcome measures
| Measure |
Total
n=408 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=43 Participants
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.)
|
High Risk
n=337 Participants
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.)
|
|---|---|---|---|---|
|
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
MCP-1 baseline
|
302.7 pg/dL
Interval 295.0 to 311.7
|
305.2 pg/dL
Interval 267.9 to 340.6
|
317.7 pg/dL
Interval 294.2 to 386.4
|
301.6 pg/dL
Interval 291.7 to 310.0
|
|
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
MCP-1 change from baseline (week 8)
|
39.8 pg/dL
Interval 21.3 to 66.7
|
-15.0 pg/dL
Interval -61.4 to 45.9
|
-22.4 pg/dL
Interval -102.9 to 42.6
|
59.4 pg/dL
Interval 33.6 to 74.9
|
|
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
IL-6 baseline
|
0.40 pg/dL
Interval 0.4 to 0.5
|
0.30 pg/dL
Interval 0.1 to 0.6
|
0.40 pg/dL
Interval 0.3 to 0.8
|
0.50 pg/dL
Interval 0.4 to 0.6
|
|
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
IL-6 change from baseline (week 8)
|
0.00 pg/dL
Interval 0.0 to 0.0
|
0.00 pg/dL
Interval -0.3 to 0.0
|
-0.10 pg/dL
Interval -0.3 to 0.0
|
0.00 pg/dL
Interval 0.0 to 0.0
|
|
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
TNF-alpha baseline
|
0.10 pg/dL
Interval 0.1 to 0.1
|
0.10 pg/dL
Interval 0.1 to 0.3
|
0.20 pg/dL
Interval 0.1 to 0.3
|
0.10 pg/dL
Interval 0.1 to 0.1
|
|
Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
TNF-alpha change from baseline (week 8)
|
0.00 pg/dL
Interval 0.0 to 0.0
|
0.00 pg/dL
Interval -0.1 to 0.0
|
0.00 pg/dL
Interval -0.1 to 0.0
|
0.00 pg/dL
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).
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
Outcome measures
| Measure |
Total
n=408 Participants
N=425 (Total=sum of all risk groups)
|
Low Risk
n=28 Participants
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.)
|
Medium Risk
n=43 Participants
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.)
|
High Risk
n=337 Participants
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.)
|
|---|---|---|---|---|
|
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
MCP-1 % change (week 8)
|
14.0 percent
Interval 7.8 to 22.3
|
-5.6 percent
Interval -18.6 to 18.7
|
-8.0 percent
Interval -34.2 to 21.4
|
18.2 percent
Interval 11.1 to 24.7
|
|
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
IL-6 % change (week 8)
|
0.00 percent
Interval 0.0 to 0.0
|
0.00 percent
Interval -50.0 to 0.0
|
-12.50 percent
Interval -45.45 to 25.0
|
0.00 percent
Interval 0.0 to 0.0
|
|
Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.
TNF-alpha % change (week 8)
|
0.00 percent
Interval 0.0 to 0.0
|
0.00 percent
Interval -50.0 to 0.0
|
0.00 percent
Interval -42.86 to 0.0
|
0.00 percent
Interval 0.0 to 0.0
|
Adverse Events
Total Treatment Group (All Subjects Who Received Atorvastatin)
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total Treatment Group (All Subjects Who Received Atorvastatin)
this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
|
|---|---|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.24%
1/425
|
|
Nervous system disorders
Cerabral infarction
|
0.47%
2/425
|
Other adverse events
| Measure |
Total Treatment Group (All Subjects Who Received Atorvastatin)
this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.9%
8/425
|
|
Nervous system disorders
Headache
|
1.4%
6/425
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER