Familial Hypercholesterolemia
Conditions
Keywords
pediatric heterozygous familial hypercholesterolemia
Brief summary
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.
Interventions
DRUGatorvastatin
Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l
Exclusion criteria
* Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN). Female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. Any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure. Known hypersensitivities to HMG-CoA reductase inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in FMD | Months 6, 12, 18, 24, 30 and 36/ET | Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. |
| Percent Change From Baseline in Age: Females | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of age during the study. |
| Flow-Mediated Dilatation (FMD) During the Study | Baseline, Months 6, 12, 18, 24, 30 and 36/ET | Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined. |
| Percent Change From Baseline in Age: Males | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of age during the study. |
| Percent Change From Baseline in Weight: Females | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of weight changes during the study. |
| Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of BMI changes during the study. Change from baseline was also determined. |
| Percent Change From Baseline in BMI: Males | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of BMI changes during the study. |
| Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET]) | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in LDL-C | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET) | Assessments were performed in the fasting state (minimum 10-hour fast). |
| High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in HDL-C | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). |
| Total Cholesterol (mMol/L) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in Total Cholesterol | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). |
| Trigylcerides (mMol/L) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in Trigylcerides | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). |
| Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in VLDL | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). |
| Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in Apo A-1 | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). |
| Apoliprotein B (Apo B; g/L) During the Study | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined. |
| Percent Change From Baseline in Apo B | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Assessments were performed in the fasting state (minimum 10-hour fast). |
| Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Baseline, Months 6, 12, 18, 24, 30, and 36/ET | Tanner\_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner\_Stage had the higher value of 2 components for each gender by visit. |
| BMI (kg/m^2) During the Study: Females | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of BMI changes during the study. Change from baseline was also determined. |
| Percent Change From Baseline in BMI: Females | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of BMI changes during the study. |
| Age (Years) During the Study: Males | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of age during the study. Change from baseline was also determined. |
| Height (Centimeters [cm]) During the Study: Males | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of height changes during the study. Change from baseline was also determined. |
| Percent Change From Baseline in Height: Males | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of height changes during the study. |
| Height (cm) During the Study: Females | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of height changes during the study. Change from baseline was also determined. |
| Percent Change From Baseline in Height: Females | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of height changes during the study. |
| Weight (Kilograms [kg]) During the Study: Males | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of weight changes during the study. Change from baseline was also determined. |
| Percent Change From Baseline in Weight: Males | Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of weight changes during the study. |
| Weight (kg) During the Study: Females | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of weight changes during the study. Change from baseline was also determined. |
| Age (Years) During the Study: Females | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET | Investigator assessment of age during the study. Change from baseline was also determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants by Study Drug Compliance Category | Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination) | Compliance to study drug was categorized as \<80%, 80% - 120%, and greater than (\>) 120%. |
| Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination) | — |
Countries
Belgium, Canada, Germany, Greece, Hungary, Italy, Norway, Poland, Puerto Rico, Russia, Slovakia, Spain, Switzerland, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 Participants aged 6 to \<10 years, at Tanner\_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (\<3.35 mmol/L) was not attained. | 139 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ Participants aged ≥10 to 15 years, at Tanner\_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (\<3.35 mmol/L) was not attained. | 132 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | LDL below 2.59 mmol/L | 4 | 12 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Other | 5 | 13 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | Atorvastatin (5-80 mg): Tanner_Stage 1 | Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total |
|---|---|---|---|
| Age, Continuous | 8.5 years STANDARD_DEVIATION 1.86 | 12.0 years STANDARD_DEVIATION 1.68 | 10.2 years STANDARD_DEVIATION 2.48 |
| Sex: Female, Male Female | 46 Participants | 79 Participants | 125 Participants |
| Sex: Female, Male Male | 93 Participants | 53 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 93 / 139 | 86 / 132 |
| serious Total, serious adverse events | 14 / 139 | 7 / 132 |
Outcome results
Primary
Age (Years) During the Study: Females
Investigator assessment of age during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 1 (n=125) | 0.11 years | Standard Deviation 0.317 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Baseline (n=125) | 10.55 years | Standard Deviation 2.421 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 1 (n=125) | 10.66 years | Standard Deviation 2.436 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 2 (n=120) | 10.78 years | Standard Deviation 2.43 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 2 (n=120) | 0.20 years | Standard Deviation 0.402 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 3 (n=115) | 10.75 years | Standard Deviation 2.449 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 3 (n=115) | 0.28 years | Standard Deviation 0.45 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 6 (n=113) | 10.99 years | Standard Deviation 2.477 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 6 (n=113) | 0.52 years | Standard Deviation 0.502 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 12 (n=107) | 11.50 years | Standard Deviation 2.416 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 12 (n=107) | 0.99 years | Standard Deviation 0.097 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 18 (n=99) | 12.02 years | Standard Deviation 2.503 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 18 (n=99) | 1.52 years | Standard Deviation 0.502 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 24 (n=95) | 12.42 years | Standard Deviation 2.482 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 24 (n=95) | 1.98 years | Standard Deviation 0.144 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 30 (n=93) | 12.99 years | Standard Deviation 2.564 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 30 (n=93) | 2.52 years | Standard Deviation 0.502 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Month 36/ET (n=121) | 13.07 years | Standard Deviation 2.547 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Females | Change at Month 36/ET (n=121) | 2.54 years | Standard Deviation 0.94 |
Primary
Age (Years) During the Study: Males
Investigator assessment of age during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Baseline (n=146) | 9.94 years | Standard Deviation 2.489 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 1 (n=141) | 10.05 years | Standard Deviation 2.553 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 1 (n=141) | 0.11 years | Standard Deviation 0.309 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 2 (n=138) | 10.14 years | Standard Deviation 2.583 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 2 (n=138) | 0.18 years | Standard Deviation 0.387 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 3 (n=133) | 10.21 years | Standard Deviation 2.567 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 3 (n=133) | 0.29 years | Standard Deviation 0.457 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 6 (n=129) | 10.43 years | Standard Deviation 2.552 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 6 (n=129) | 0.55 years | Standard Deviation 0.499 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 12 (n=123) | 10.96 years | Standard Deviation 2.543 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 12 (n=123) | 1.02 years | Standard Deviation 0.155 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 18 (n=119) | 11.47 years | Standard Deviation 2.544 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 18 (n=119) | 1.54 years | Standard Deviation 0.501 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 24 (n=114) | 11.93 years | Standard Deviation 2.534 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 24 (n=114) | 2.02 years | Standard Deviation 0.132 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 30 (n=114) | 12.46 years | Standard Deviation 2.553 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 30 (n=114) | 2.54 years | Standard Deviation 0.5 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Month 36/ET (n=134) | 12.69 years | Standard Deviation 2.587 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Age (Years) During the Study: Males | Change at Month 36/ET (n=134) | 2.67 years | Standard Deviation 0.899 |
Primary
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 3 (n=126,117) | 1.405 g/L | Standard Deviation 0.1914 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 12 (n=120,108) | -0.041 g/L | Standard Deviation 0.1574 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 2 (n=131,123) | 1.411 g/L | Standard Deviation 0.1952 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 18 (n=114,100) | 1.339 g/L | Standard Deviation 0.1972 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 3 (n=126,117) | 0.005 g/L | Standard Deviation 0.1713 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 18 (n=114,100) | -0.049 g/L | Standard Deviation 0.1558 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 1 (n=132,130) | 0.025 g/L | Standard Deviation 0.1639 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 24 (n=113,95) | 1.364 g/L | Standard Deviation 0.1929 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 6 (n=123,110) | 1.386 g/L | Standard Deviation 0.2081 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 24 (n=113,95) | -0.032 g/L | Standard Deviation 0.1749 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 2 (n=131,123) | 0.016 g/L | Standard Deviation 0.1519 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 30 (n=112,95) | 1.357 g/L | Standard Deviation 0.2247 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 6 (n=123,110) | -0.007 g/L | Standard Deviation 0.1609 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 30 (n=112,95) | -0.040 g/L | Standard Deviation 0.1857 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 1 (n=132,130) | 1.419 g/L | Standard Deviation 0.2233 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 36/ET (n=125,118) | 1.327 g/L | Standard Deviation 0.2081 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 12 (n=120,108) | 1.347 g/L | Standard Deviation 0.1893 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 36/ET (n=125,118) | -0.073 g/L | Standard Deviation 0.1725 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Baseline (n=138,132) | 1.396 g/L | Standard Deviation 0.1839 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 36/ET (n=125,118) | -0.040 g/L | Standard Deviation 0.1676 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Baseline (n=138,132) | 1.308 g/L | Standard Deviation 0.2006 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 1 (n=132,130) | 1.337 g/L | Standard Deviation 0.1927 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 1 (n=132,130) | 0.032 g/L | Standard Deviation 0.1506 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 2 (n=131,123) | 1.334 g/L | Standard Deviation 0.195 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 2 (n=131,123) | 0.025 g/L | Standard Deviation 0.1355 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 3 (n=126,117) | 1.306 g/L | Standard Deviation 0.1919 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 3 (n=126,117) | 0.006 g/L | Standard Deviation 0.1557 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 6 (n=123,110) | 1.329 g/L | Standard Deviation 0.1894 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 6 (n=123,110) | 0.026 g/L | Standard Deviation 0.1818 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 12 (n=120,108) | 1.271 g/L | Standard Deviation 0.1798 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 12 (n=120,108) | -0.028 g/L | Standard Deviation 0.1586 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 18 (n=114,100) | 1.266 g/L | Standard Deviation 0.1676 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 18 (n=114,100) | -0.038 g/L | Standard Deviation 0.1643 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 24 (n=113,95) | 1.275 g/L | Standard Deviation 0.1736 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 24 (n=113,95) | -0.027 g/L | Standard Deviation 0.1799 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 30 (n=112,95) | 1.268 g/L | Standard Deviation 0.1848 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Change at Month 30 (n=112,95) | -0.036 g/L | Standard Deviation 0.1861 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study | Month 36/ET (n=125,118) | 1.272 g/L | Standard Deviation 0.1664 |
Primary
Apoliprotein B (Apo B; g/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 1 (n=132,130) | 1.062 g/L | Standard Deviation 0.2423 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 3 (n=126,117) | 0.930 g/L | Standard Deviation 0.1836 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 12 (n=120,108) | -0.548 g/L | Standard Deviation 0.2131 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Baseline (n=138,132) | 1.454 g/L | Standard Deviation 0.289 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 18 (n=114,100) | 0.893 g/L | Standard Deviation 0.1546 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 3 (n=126,117) | -0.522 g/L | Standard Deviation 0.2152 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 18 (n=114,100) | -0.578 g/L | Standard Deviation 0.2343 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 2 (n=131,123) | 0.980 g/L | Standard Deviation 0.1929 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 24 (n=113,95) | 0.918 g/L | Standard Deviation 0.1719 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 6 (n=123,110) | 0.919 g/L | Standard Deviation 0.1557 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 24 (n=113,95) | -0.551 g/L | Standard Deviation 0.2353 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 1 (n=132,130) | -0.395 g/L | Standard Deviation 0.1599 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 30 (n=112,95) | 0.910 g/L | Standard Deviation 0.1723 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 30 (n=112,95) | -0.560 g/L | Standard Deviation 0.2664 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 6 (n=123,110) | -0.535 g/L | Standard Deviation 0.2092 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 36/ET (n=125,118) | 0.926 g/L | Standard Deviation 0.186 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 2 (n=131,123) | -0.471 g/L | Standard Deviation 0.1825 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 36/ET (n=125,118) | -0.520 g/L | Standard Deviation 0.273 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Apoliprotein B (Apo B; g/L) During the Study | Month 12 (n=120,108) | 0.918 g/L | Standard Deviation 0.1816 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 36/ET (n=125,118) | -0.450 g/L | Standard Deviation 0.2748 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Baseline (n=138,132) | 1.381 g/L | Standard Deviation 0.2619 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 1 (n=132,130) | -0.415 g/L | Standard Deviation 0.1691 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 2 (n=131,123) | 0.916 g/L | Standard Deviation 0.1813 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 2 (n=131,123) | -0.484 g/L | Standard Deviation 0.1858 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 3 (n=126,117) | 0.890 g/L | Standard Deviation 0.1707 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 3 (n=126,117) | -0.518 g/L | Standard Deviation 0.2184 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 6 (n=123,110) | 0.910 g/L | Standard Deviation 0.1683 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 6 (n=123,110) | -0.503 g/L | Standard Deviation 0.2086 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 30 (n=112,95) | 0.885 g/L | Standard Deviation 0.1717 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 12 (n=120,108) | 0.871 g/L | Standard Deviation 0.1493 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 12 (n=120,108) | -0.530 g/L | Standard Deviation 0.2194 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 18 (n=114,100) | 0.882 g/L | Standard Deviation 0.1293 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 18 (n=114,100) | -0.533 g/L | Standard Deviation 0.2463 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 24 (n=113,95) | 0.884 g/L | Standard Deviation 0.1575 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 24 (n=113,95) | -0.535 g/L | Standard Deviation 0.2344 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Change at Month 30 (n=112,95) | -0.533 g/L | Standard Deviation 0.2467 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 36/ET (n=125,118) | 0.924 g/L | Standard Deviation 0.2173 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Apoliprotein B (Apo B; g/L) During the Study | Month 1 (n=132,130) | 0.967 g/L | Standard Deviation 0.2257 |
Primary
BMI (kg/m^2) During the Study: Females
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 1 (n=124) | 19.45 kg/m^2 | Standard Deviation 3.973 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Baseline (n=125) | 19.44 kg/m^2 | Standard Deviation 3.994 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 1 (n=124) | -0.02 kg/m^2 | Standard Deviation 0.582 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 2 (n=119) | 19.47 kg/m^2 | Standard Deviation 3.94 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 2 (n=119) | 0.00 kg/m^2 | Standard Deviation 0.756 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 3 (n=115) | 19.54 kg/m^2 | Standard Deviation 4.171 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 3 (n=115) | 0.13 kg/m^2 | Standard Deviation 0.861 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 6 (n=113) | 19.68 kg/m^2 | Standard Deviation 4.288 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 6 (n=113) | 0.24 kg/m^2 | Standard Deviation 1.004 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 12 (n=107) | 19.98 kg/m^2 | Standard Deviation 4.257 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 12 (n=107) | 0.60 kg/m^2 | Standard Deviation 1.305 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 18 (n=99) | 20.24 kg/m^2 | Standard Deviation 3.99 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 18 (n=99) | 0.92 kg/m^2 | Standard Deviation 1.432 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 24 (n=95) | 20.50 kg/m^2 | Standard Deviation 3.976 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 24 (n=95) | 1.38 kg/m^2 | Standard Deviation 1.624 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 30 (n=93) | 20.75 kg/m^2 | Standard Deviation 4.014 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 30 (n=93) | 1.59 kg/m^2 | Standard Deviation 1.931 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Month 36/ET (n=121) | 20.71 kg/m^2 | Standard Deviation 4.217 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | BMI (kg/m^2) During the Study: Females | Change at Month 36/ET (n=121) | 1.46 kg/m^2 | Standard Deviation 1.948 |
Primary
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Baseline (n=146) | 18.97 kg/m^2 | Standard Deviation 3.664 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 1 (n=141) | 18.94 kg/m^2 | Standard Deviation 3.751 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 1 (n=141) | 0.01 kg/m^2 | Standard Deviation 0.577 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 2 (n=138) | 19.06 kg/m^2 | Standard Deviation 3.755 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 2 (n=138) | 0.06 kg/m^2 | Standard Deviation 0.658 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 3 (n=133) | 18.99 kg/m^2 | Standard Deviation 3.745 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 3 (n=133) | 0.07 kg/m^2 | Standard Deviation 0.89 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 6 (n=129) | 19.04 kg/m^2 | Standard Deviation 3.881 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 6 (n=129) | 0.10 kg/m^2 | Standard Deviation 1.218 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 12 (n=123) | 19.34 kg/m^2 | Standard Deviation 3.922 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 12 (n=123) | 0.37 kg/m^2 | Standard Deviation 1.541 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 18 (n=119) | 19.65 kg/m^2 | Standard Deviation 4.053 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 18 (n=119) | 0.73 kg/m^2 | Standard Deviation 1.625 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 24 (n=114) | 19.91 kg/m^2 | Standard Deviation 4.098 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 24 (n=114) | 0.99 kg/m^2 | Standard Deviation 1.745 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 30 (n=114) | 20.18 kg/m^2 | Standard Deviation 4.4 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 30 (n=114) | 1.25 kg/m^2 | Standard Deviation 2.099 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Month 36/ET (n=134) | 20.28 kg/m^2 | Standard Deviation 4.137 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males | Change at Month 36/ET (n=134) | 1.33 kg/m^2 | Standard Deviation 1.958 |
Primary
Flow-Mediated Dilatation (FMD) During the Study
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
Time frame: Baseline, Months 6, 12, 18, 24, 30 and 36/ET
Population: FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 6 (n=27,23) | -0.063 % FMD | Standard Deviation 3.4768 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Month 24 (n=33,28) | 4.538 % FMD | Standard Deviation 2.4239 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 12 (n=32,29) | -0.952 % FMD | Standard Deviation 3.6796 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 24 (n=33,28) | -1.166 % FMD | Standard Deviation 3.2524 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Month 6 (n=27,23) | 5.749 % FMD | Standard Deviation 2.5047 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Month 30 (n=33,28) | 5.571 % FMD | Standard Deviation 2.7198 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Month 18 (n=33,28) | 4.942 % FMD | Standard Deviation 2.674 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 30 (n=33,28) | -0.134 % FMD | Standard Deviation 3.3399 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Month 12 (n=32,29) | 4.732 % FMD | Standard Deviation 1.8477 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Month 36/ET (n=34,33) | 4.987 % FMD | Standard Deviation 2.254 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 18 (n=33,28) | -0.762 % FMD | Standard Deviation 3.7374 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 36/ET (n=34,33) | -0.550 % FMD | Standard Deviation 3.6625 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Flow-Mediated Dilatation (FMD) During the Study | Baseline (n=37,36) | 5.523 % FMD | Standard Deviation 3.2062 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 36/ET (n=34,33) | -1.563 % FMD | Standard Deviation 4.8355 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Baseline (n=37,36) | 6.651 % FMD | Standard Deviation 4.4926 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Month 6 (n=27,23) | 6.520 % FMD | Standard Deviation 4.0763 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 6 (n=27,23) | -0.759 % FMD | Standard Deviation 4.8732 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Month 12 (n=32,29) | 6.363 % FMD | Standard Deviation 8.037 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 12 (n=32,29) | -0.778 % FMD | Standard Deviation 9.4743 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Month 18 (n=33,28) | 4.668 % FMD | Standard Deviation 3.8874 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 18 (n=33,28) | -2.556 % FMD | Standard Deviation 6.3123 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Month 24 (n=33,28) | 5.679 % FMD | Standard Deviation 4.3224 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 24 (n=33,28) | -1.545 % FMD | Standard Deviation 7.2325 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Month 30 (n=33,28) | 5.191 % FMD | Standard Deviation 2.512 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Change at Month 30 (n=33,28) | -2.033 % FMD | Standard Deviation 5.8591 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Flow-Mediated Dilatation (FMD) During the Study | Month 36/ET (n=34,33) | 5.360 % FMD | Standard Deviation 2.9873 |
Primary
Height (Centimeters [cm]) During the Study: Males
Investigator assessment of height changes during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Baseline (n=146) | 144.36 cm | Standard Deviation 16.004 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 1 (n=141) | 145.21 cm | Standard Deviation 16.114 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 1 (n=141) | 0.68 cm | Standard Deviation 0.964 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 2 (n=138) | 145.93 cm | Standard Deviation 16.302 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 2 (n=138) | 1.27 cm | Standard Deviation 0.964 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 3 (n=133) | 146.00 cm | Standard Deviation 16.139 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 3 (n=133) | 1.72 cm | Standard Deviation 1.172 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 6 (n=129) | 147.17 cm | Standard Deviation 16.033 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 6 (n=129) | 3.24 cm | Standard Deviation 1.485 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 12 (n=123) | 150.75 cm | Standard Deviation 16.321 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 12 (n=123) | 6.67 cm | Standard Deviation 2.385 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 18 (n=119) | 153.26 cm | Standard Deviation 16.388 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 18 (n=119) | 9.31 cm | Standard Deviation 2.978 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 24 (n=114) | 156.03 cm | Standard Deviation 16.001 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 24 (n=114) | 12.11 cm | Standard Deviation 3.63 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 30 (n=114) | 158.78 cm | Standard Deviation 15.77 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 30 (n=114) | 14.86 cm | Standard Deviation 4.403 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Month 36/ET (n=134) | 160.59 cm | Standard Deviation 15.602 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (Centimeters [cm]) During the Study: Males | Change at Month 36/ET (n=134) | 15.53 cm | Standard Deviation 6.801 |
Primary
Height (cm) During the Study: Females
Investigator assessment of height changes during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Baseline (n=125) | 145.28 cm | Standard Deviation 14.108 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 1 (n=124) | 146.06 cm | Standard Deviation 14.045 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 1 (n=124) | 0.71 cm | Standard Deviation 1.378 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 2 (n=119) | 146.57 cm | Standard Deviation 13.919 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 2 (n=119) | 1.19 cm | Standard Deviation 1.7 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 3 (n=115) | 146.81 cm | Standard Deviation 13.838 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 3 (n=115) | 1.68 cm | Standard Deviation 1.278 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 6 (n=113) | 147.87 cm | Standard Deviation 13.619 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 6 (n=113) | 2.77 cm | Standard Deviation 1.72 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 12 (n=107) | 150.84 cm | Standard Deviation 12.968 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 12 (n=107) | 5.50 cm | Standard Deviation 2.992 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 18 (n=99) | 152.77 cm | Standard Deviation 12.648 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 18 (n=99) | 7.41 cm | Standard Deviation 4.043 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 24 (n=95) | 154.79 cm | Standard Deviation 11.913 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 24 (n=95) | 9.61 cm | Standard Deviation 5.12 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 30 (n=93) | 156.43 cm | Standard Deviation 11.288 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 30 (n=93) | 11.23 cm | Standard Deviation 6.118 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Month 36/ET (n=121) | 156.52 cm | Standard Deviation 11.032 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Height (cm) During the Study: Females | Change at Month 36/ET (n=121) | 11.23 cm | Standard Deviation 7.551 |
Primary
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 36/ET (n=123,117) | 1.335 mMol/L | Standard Deviation 0.2918 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 1 (n=131,130) | 0.010 mMol/L | Standard Deviation 0.1685 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 3 (n=126,117) | 1.371 mMol/L | Standard Deviation 0.2768 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 6 (n=127,115) | -0.011 mMol/L | Standard Deviation 0.1848 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 18 (n=116,102) | 0.024 mMol/L | Standard Deviation 0.1923 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 30 (n=112,94) | 0.032 mMol/L | Standard Deviation 0.1997 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -0.024 mMol/L | Standard Deviation 0.1949 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Baseline (n=139,132) | 1.349 mMol/L | Standard Deviation 0.2732 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 1 (n=131,130) | 1.360 mMol/L | Standard Deviation 0.2717 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 2 (n=132,122) | 1.364 mMol/L | Standard Deviation 0.2805 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 2 (n=132,122) | 0.014 mMol/L | Standard Deviation 0.2238 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 3 (n=126,117) | 0.015 mMol/L | Standard Deviation 0.1943 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 6 (n=127,115) | 1.337 mMol/L | Standard Deviation 0.2834 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 12 (n=121,109) | 1.328 mMol/L | Standard Deviation 0.2885 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 12 (n=121,109) | -0.012 mMol/L | Standard Deviation 0.1945 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 18 (n=116,102) | 1.367 mMol/L | Standard Deviation 0.3003 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 24 (n=111,96) | 1.385 mMol/L | Standard Deviation 0.2729 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 24 (n=111,96) | 0.027 mMol/L | Standard Deviation 0.2043 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 30 (n=112,94) | 1.380 mMol/L | Standard Deviation 0.2942 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 24 (n=111,96) | 1.266 mMol/L | Standard Deviation 0.2443 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 2 (n=132,122) | 1.297 mMol/L | Standard Deviation 0.2625 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 1 (n=131,130) | 0.016 mMol/L | Standard Deviation 0.174 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 2 (n=132,122) | 0.025 mMol/L | Standard Deviation 0.16 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 12 (n=121,109) | -0.023 mMol/L | Standard Deviation 0.1727 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 6 (n=127,115) | 1.268 mMol/L | Standard Deviation 0.2311 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 3 (n=126,117) | 1.274 mMol/L | Standard Deviation 0.2606 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 6 (n=127,115) | 0.010 mMol/L | Standard Deviation 0.1833 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 1 (n=131,130) | 1.292 mMol/L | Standard Deviation 0.265 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 18 (n=116,102) | -0.027 mMol/L | Standard Deviation 0.1744 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 30 (n=112,94) | 1.265 mMol/L | Standard Deviation 0.2487 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 3 (n=126,117) | 0.011 mMol/L | Standard Deviation 0.1837 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 30 (n=112,94) | 0.006 mMol/L | Standard Deviation 0.215 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 36/ET (n=123,117) | 1.278 mMol/L | Standard Deviation 0.2516 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 18 (n=116,102) | 1.234 mMol/L | Standard Deviation 0.2349 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 36/ET (n=123,117) | 0.005 mMol/L | Standard Deviation 0.1975 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Change at Month 24 (n=111,96) | 0.007 mMol/L | Standard Deviation 0.191 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Baseline (n=139,132) | 1.277 mMol/L | Standard Deviation 0.2546 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study | Month 12 (n=121,109) | 1.241 mMol/L | Standard Deviation 0.2429 |
Primary
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Population: FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 6 (n=127,115) | 3.366 mMol/L | Standard Deviation 0.5787 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 1 (n=131,130) | -2.214 mMol/L | Standard Deviation 0.7568 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 6 (n=127,115) | -2.968 mMol/L | Standard Deviation 1.1096 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 2 (n=132,122) | 3.719 mMol/L | Standard Deviation 0.8346 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 12 (n=121,109) | 3.409 mMol/L | Standard Deviation 0.7395 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Baseline (n=139,132) | 6.304 mMol/L | Standard Deviation 1.313 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 12 (n=121,109) | -2.966 mMol/L | Standard Deviation 1.0987 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 2 (n=132,122) | -2.586 mMol/L | Standard Deviation 0.9297 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 18 (n=116,101) | -3.105 mMol/L | Standard Deviation 1.1558 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 24 (n=111,96) | -3.088 mMol/L | Standard Deviation 1.2026 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 24 (n=111,96) | 3.316 mMol/L | Standard Deviation 0.6803 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 3 (n=126,117) | 3.503 mMol/L | Standard Deviation 0.7566 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 30 (n=112,94) | 3.335 mMol/L | Standard Deviation 0.649 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 1 (n=131,130) | 4.087 mMol/L | Standard Deviation 1.0264 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 30 (n=112,94) | -3.090 mMol/L | Standard Deviation 1.2402 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 36/ET (n=123,117) | 3.450 mMol/L | Standard Deviation 0.7372 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 3 (n=126,117) | -2.798 mMol/L | Standard Deviation 1.0251 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 36/ET (n=123,117) | -2.855 mMol/L | Standard Deviation 1.2625 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 18 (n=116,101) | 3.309 mMol/L | Standard Deviation 0.5933 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 36/ET (n=123,117) | -2.468 mMol/L | Standard Deviation 1.327 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 12 (n=121,109) | -2.838 mMol/L | Standard Deviation 1.145 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 24 (n=111,96) | 3.189 mMol/L | Standard Deviation 0.6537 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 30 (n=112,94) | -3.008 mMol/L | Standard Deviation 1.1489 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Baseline (n=139,132) | 5.921 mMol/L | Standard Deviation 1.1646 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 1 (n=131,130) | 3.675 mMol/L | Standard Deviation 0.8749 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 2 (n=132,122) | 3.437 mMol/L | Standard Deviation 0.7438 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 2 (n=132,122) | -2.554 mMol/L | Standard Deviation 0.9155 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 3 (n=126,117) | 3.270 mMol/L | Standard Deviation 0.6533 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 3 (n=126,117) | -2.795 mMol/L | Standard Deviation 1.0835 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 6 (n=127,115) | 3.347 mMol/L | Standard Deviation 0.5953 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 6 (n=127,115) | -2.732 mMol/L | Standard Deviation 1.066 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 12 (n=121,109) | 3.196 mMol/L | Standard Deviation 0.6565 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 18 (n=116,101) | 3.261 mMol/L | Standard Deviation 0.5288 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 18 (n=116,101) | -2.835 mMol/L | Standard Deviation 1.2128 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 24 (n=111,96) | -2.933 mMol/L | Standard Deviation 1.2292 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 30 (n=112,94) | 3.142 mMol/L | Standard Deviation 0.6916 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Month 36/ET (n=123,117) | 3.457 mMol/L | Standard Deviation 0.8808 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study | Change at Month 1 (n=131,130) | -2.233 mMol/L | Standard Deviation 0.8009 |
Primary
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
Tanner\_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner\_Stage had the higher value of 2 components for each gender by visit.
Time frame: Baseline, Months 6, 12, 18, 24, 30, and 36/ET
Population: FAS; n=number of participants assessed for the specific parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 18 (n=115,41, 21,25,14) | 31 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 12 (n=121,43,23,26,15) | 85 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18) | 5 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 18 (n=115,41, 21,25,14) | 63 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 12 (n=121,43,23,26,15) | 1 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 12 (n=121,43,23,26,15) | 25 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 6 (n=126,48,25,27,15) | 107 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 12 (n=121,43,23,26,15) | 10 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18) | 25 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18) | 31 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18) | 41 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2 , Month 6 (n=126,48,25,27,15) | 14 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18) | 25 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 30 (n=111,38,19,23,14) | 14 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 30 (n=111,38,19,23,14) | 32 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 6 (n=126,48,25,27,15) | 5 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 30 (n=111,38,19,23,14) | 39 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 24 (n=113,38,19,22,14) | 9 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 24 (n=113,38,19,22,14) | 20 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 24 (n=113,38,19,22,14) | 33 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 24 (n=113,38,19,22,14) | 51 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 30 (n=111,38,19,23,14) | 26 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 18 (n=115,41, 21,25,14) | 3 participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 18 (n=115,41, 21,25,14) | 18 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 6 (n=126,48,25,27,15) | 10 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 6 (n=126,48,25,27,15) | 4 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 18 (n=115,41, 21,25,14) | 15 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 30 (n=111,38,19,23,14) | 11 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2 , Month 6 (n=126,48,25,27,15) | 34 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 12 (n=121,43,23,26,15) | 17 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 12 (n=121,43,23,26,15) | 21 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 12 (n=121,43,23,26,15) | 5 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 18 (n=115,41, 21,25,14) | 16 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 18 (n=115,41, 21,25,14) | 9 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 18 (n=115,41, 21,25,14) | 1 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 24 (n=113,38,19,22,14) | 9 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 24 (n=113,38,19,22,14) | 14 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 24 (n=113,38,19,22,14) | 12 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 24 (n=113,38,19,22,14) | 3 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 30 (n=111,38,19,23,14) | 3 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 30 (n=111,38,19,23,14) | 18 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 30 (n=111,38,19,23,14) | 6 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18) | 6 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18) | 10 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18) | 24 participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18) | 12 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 24 (n=113,38,19,22,14) | 2 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 30 (n=111,38,19,23,14) | 1 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 18 (n=115,41, 21,25,14) | 11 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 24 (n=113,38,19,22,14) | 13 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18) | 13 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 6 (n=126,48,25,27,15) | 14 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 12 (n=121,43,23,26,15) | 10 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 24 (n=113,38,19,22,14) | 4 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 12 (n=121,43,23,26,15) | 11 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18) | 10 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 18 (n=115,41, 21,25,14) | 4 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 18 (n=115,41, 21,25,14) | 6 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 30 (n=111,38,19,23,14) | 9 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2 , Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 6 (n=126,48,25,27,15) | 11 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18) | 2 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 12 (n=121,43,23,26,15) | 2 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 30 (n=111,38,19,23,14) | 9 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 3 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 6 (n=126,48,25,27,15) | 2 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 18 (n=115,41, 21,25,14) | 18 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 18 (n=115,41, 21,25,14) | 7 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 6 (n=126,48,25,27,15) | 25 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18) | 19 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 24 (n=113,38,19,22,14) | 13 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 24 (n=113,38,19,22,14) | 9 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2 , Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 30 (n=111,38,19,23,14) | 11 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18) | 12 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 30 (n=111,38,19,23,14) | 12 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 12 (n=121,43,23,26,15) | 22 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 12 (n=121,43,23,26,15) | 4 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 4 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 12 (n=121,43,23,26,15) | 1 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 30 (n=111,38,19,23,14) | 13 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 18 (n=115,41, 21,25,14) | 13 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 18 (n=115,41, 21,25,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 6 (n=126,48,25,27,15) | 1 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 6 (n=126,48,25,27,15) | 14 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 24 (n=113,38,19,22,14) | 13 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2 , Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 24 (n=113,38,19,22,14) | 1 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 36/ET (n=127,52,25,31,18) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 1, Month 12 (n=121,43,23,26,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 12 (n=121,43,23,26,15) | 14 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 30 (n=111,38,19,23,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 18 (n=115,41, 21,25,14) | 1 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 5, Month 36/ET (n=127,52,25,31,18) | 18 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 3, Month 6 (n=126,48,25,27,15) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 2, Month 24 (n=113,38,19,22,14) | 0 participants |
| Atorvastatin (10-80 mg): Baseline Tanner_Stage 5 | Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage | Tanner_Stage 4, Month 30 (n=111,38,19,23,14) | 1 participants |
Primary
Percent Change From Baseline in Age: Females
Investigator assessment of age during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 3 (n=115) | 2.74 percent change | Standard Deviation 4.549 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 6 (n=113) | 5.18 percent change | Standard Deviation 5.221 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 12 (n=107) | 10.00 percent change | Standard Deviation 2.811 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 18 (n=99) | 15.20 percent change | Standard Deviation 6.006 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 24 (n=95) | 20.08 percent change | Standard Deviation 5.298 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 30 (n=93) | 25.35 percent change | Standard Deviation 7.415 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 36/ET (n=121) | 25.73 percent change | Standard Deviation 12.168 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 1 (n=125) | 1.10 percent change | Standard Deviation 3.169 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Females | Month 2 (n=120) | 2.00 percent change | Standard Deviation 4.128 |
Primary
Percent Change From Baseline in Age: Males
Investigator assessment of age during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 1 (n=141) | 1.09 percent change | Standard Deviation 3.327 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 2 (n=138) | 1.86 percent change | Standard Deviation 4.184 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 3 (n=133) | 3.16 percent change | Standard Deviation 5.175 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 6 (n=129) | 6.06 percent change | Standard Deviation 5.956 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 12 (n=123) | 11.13 percent change | Standard Deviation 3.878 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 18 (n=119) | 16.82 percent change | Standard Deviation 7.732 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 24 (n=114) | 21.92 percent change | Standard Deviation 6.623 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 30 (n=114) | 27.67 percent change | Standard Deviation 9.855 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Age: Males | Month 36/ET (n=134) | 28.90 percent change | Standard Deviation 13.486 |
Primary
Percent Change From Baseline in Apo A-1
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 2 (n=131,123) | 1.701 percent change | Standard Deviation 11.0364 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 18 (n=114,100) | -3.042 percent change | Standard Deviation 11.2219 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 6 (n=123,110) | -0.069 percent change | Standard Deviation 12.1109 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 24 (n=113,95) | -1.611 percent change | Standard Deviation 12.4618 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 3 (n=126,117) | 1.041 percent change | Standard Deviation 12.4204 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 30 (n=112,95) | -2.342 percent change | Standard Deviation 13.3357 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 12 (n=120,108) | -2.365 percent change | Standard Deviation 11.5882 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 36/ET (n=125,118) | -4.804 percent change | Standard Deviation 12.0443 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo A-1 | Month 1 (n=132,130) | 2.229 percent change | Standard Deviation 12.4001 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 36/ET (n=125,118) | -1.954 percent change | Standard Deviation 12.7229 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 1 (n=132,130) | 3.301 percent change | Standard Deviation 12.2009 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 2 (n=131,123) | 2.499 percent change | Standard Deviation 10.7656 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 3 (n=126,117) | 1.192 percent change | Standard Deviation 12.164 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 6 (n=123,110) | 3.011 percent change | Standard Deviation 14.1347 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 12 (n=120,108) | -1.370 percent change | Standard Deviation 12.3901 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 18 (n=114,100) | -1.980 percent change | Standard Deviation 12.217 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 24 (n=113,95) | -0.961 percent change | Standard Deviation 13.9868 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo A-1 | Month 30 (n=112,95) | -1.695 percent change | Standard Deviation 14.2732 |
Primary
Percent Change From Baseline in Apo B
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 24 (n=113,95) | -36.426 percent change | Standard Deviation 11.4333 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 30 (n=112,95) | -36.668 percent change | Standard Deviation 12.8783 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 36/ET (n=125,118) | -34.507 percent change | Standard Deviation 14.074 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 1 (n=132,130) | -26.933 percent change | Standard Deviation 9.555 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 2 (n=131,123) | -31.867 percent change | Standard Deviation 9.2821 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 3 (n=126,117) | -35.163 percent change | Standard Deviation 10.568 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 6 (n=123,110) | -35.900 percent change | Standard Deviation 9.3398 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 12 (n=120,108) | -36.624 percent change | Standard Deviation 9.7413 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Apo B | Month 18 (n=114,100) | -38.158 percent change | Standard Deviation 10.4084 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 12 (n=120,108) | -36.842 percent change | Standard Deviation 11.6106 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 3 (n=126,117) | -35.849 percent change | Standard Deviation 11.6832 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 30 (n=112,95) | -36.453 percent change | Standard Deviation 13.6888 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 24 (n=113,95) | -36.677 percent change | Standard Deviation 12.1824 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 36/ET (n=125,118) | -31.362 percent change | Standard Deviation 16.477 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 6 (n=123,110) | -34.740 percent change | Standard Deviation 10.7982 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 1 (n=132,130) | -29.851 percent change | Standard Deviation 10.3544 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 18 (n=114,100) | -36.211 percent change | Standard Deviation 12.7805 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Apo B | Month 2 (n=131,123) | -33.959 percent change | Standard Deviation 9.9478 |
Primary
Percent Change From Baseline in BMI: Females
Investigator assessment of BMI changes during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 1 (n=124) | -0.06 percent change | Standard Deviation 3.058 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 2 (n=119) | 0.16 percent change | Standard Deviation 3.777 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 3 (n=115) | 0.73 percent change | Standard Deviation 4.314 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 6 (n=113) | 1.26 percent change | Standard Deviation 4.992 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 12 (n=107) | 3.33 percent change | Standard Deviation 6.765 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 18 (n=99) | 5.14 percent change | Standard Deviation 7.578 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 24 (n=95) | 7.68 percent change | Standard Deviation 8.661 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 30 (n=93) | 8.89 percent change | Standard Deviation 9.916 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Females | Month 36/ET (n=121) | 8.06 percent change | Standard Deviation 10.147 |
Primary
Percent Change From Baseline in BMI: Males
Investigator assessment of BMI changes during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 36/ET (n=134) | 7.31 percent change | Standard Deviation 9.29 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 1 (n=141) | 0.03 percent change | Standard Deviation 2.953 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 2 (n=138) | 0.31 percent change | Standard Deviation 3.405 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 3 (n=133) | 0.39 percent change | Standard Deviation 4.496 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 6 (n=129) | 0.55 percent change | Standard Deviation 5.673 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 12 (n=123) | 2.10 percent change | Standard Deviation 7.065 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 18 (n=119) | 3.98 percent change | Standard Deviation 7.533 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 24 (n=114) | 5.45 percent change | Standard Deviation 8.306 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in BMI: Males | Month 30 (n=114) | 6.80 percent change | Standard Deviation 9.737 |
Primary
Percent Change From Baseline in FMD
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Time frame: Months 6, 12, 18, 24, 30 and 36/ET
Population: FMD Set; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in FMD | Month 6 (n=27,23) | 14.867 percent change | Standard Deviation 67.6028 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in FMD | Month 12 (n=32,29) | -3.880 percent change | Standard Deviation 56.191 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in FMD | Month 18 (n=33,28) | -4.598 percent change | Standard Deviation 68.0267 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in FMD | Month 24 (n=33,28) | -9.992 percent change | Standard Deviation 57.3868 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in FMD | Month 30 (n=33,28) | 7.000 percent change | Standard Deviation 63.0894 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in FMD | Month 36/ET (n=34,33) | 0.648 percent change | Standard Deviation 62.5814 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in FMD | Month 30 (n=33,28) | -18.804 percent change | Standard Deviation 42.2259 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in FMD | Month 6 (n=27,23) | -0.205 percent change | Standard Deviation 60.7192 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in FMD | Month 24 (n=33,28) | 3.850 percent change | Standard Deviation 102.2001 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in FMD | Month 12 (n=32,29) | 15.444 percent change | Standard Deviation 207.6932 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in FMD | Month 36/ET (n=34,33) | -7.506 percent change | Standard Deviation 61.2361 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in FMD | Month 18 (n=33,28) | -24.387 percent change | Standard Deviation 81.5683 |
Primary
Percent Change From Baseline in HDL-C
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 2 (n=132,122) | 2.195 percent change | Standard Deviation 15.6882 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 18 (n=116,102) | 2.472 percent change | Standard Deviation 14.8939 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 6 (n=127,115) | -0.016 percent change | Standard Deviation 14.8853 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 24 (n=111,96) | 3.014 percent change | Standard Deviation 14.9559 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 3 (n=126,117) | 1.929 percent change | Standard Deviation 14.7329 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 30 (n=112,94) | 3.345 percent change | Standard Deviation 15.508 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 12 (n=121,109) | -0.069 percent change | Standard Deviation 15.2821 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 36/ET (n=123,117) | -1.125 percent change | Standard Deviation 14.7816 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in HDL-C | Month 1 (n=131,130) | 1.526 percent change | Standard Deviation 12.7845 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 36/ET (n=123,117) | 1.602 percent change | Standard Deviation 15.4895 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 1 (n=131,130) | 2.192 percent change | Standard Deviation 14.0769 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 2 (n=132,122) | 2.544 percent change | Standard Deviation 12.7802 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 3 (n=126,117) | 1.674 percent change | Standard Deviation 14.9525 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 6 (n=127,115) | 1.877 percent change | Standard Deviation 14.9113 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 12 (n=121,109) | -1.023 percent change | Standard Deviation 14.1983 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 18 (n=116,102) | -1.165 percent change | Standard Deviation 14.3783 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 24 (n=111,96) | 1.737 percent change | Standard Deviation 15.6924 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in HDL-C | Month 30 (n=112,94) | 1.868 percent change | Standard Deviation 17.2633 |
Primary
Percent Change From Baseline in Height: Females
Investigator assessment of height changes during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 1 (n=124) | 0.51 percent change | Standard Deviation 1.004 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 3 (n=115) | 1.20 percent change | Standard Deviation 0.925 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 6 (n=113) | 1.98 percent change | Standard Deviation 1.291 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 2 (n=119) | 0.84 percent change | Standard Deviation 1.22 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 12 (n=107) | 3.93 percent change | Standard Deviation 2.262 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 18 (n=99) | 5.30 percent change | Standard Deviation 3.036 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 24 (n=95) | 6.93 percent change | Standard Deviation 3.933 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 30 (n=93) | 8.13 percent change | Standard Deviation 4.74 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Females | Month 36/ET (n=121) | 8.14 percent change | Standard Deviation 5.789 |
Primary
Percent Change From Baseline in Height: Males
Investigator assessment of height changes during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 1 (n=141) | 0.47 percent change | Standard Deviation 0.689 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 2 (n=138) | 0.88 percent change | Standard Deviation 0.652 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 3 (n=133) | 1.19 percent change | Standard Deviation 0.777 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 6 (n=129) | 2.25 percent change | Standard Deviation 0.987 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 12 (n=123) | 4.66 percent change | Standard Deviation 1.606 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 18 (n=119) | 6.53 percent change | Standard Deviation 2.021 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 24 (n=114) | 8.53 percent change | Standard Deviation 2.607 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 30 (n=114) | 10.49 percent change | Standard Deviation 3.26 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Height: Males | Month 36/ET (n=134) | 10.97 percent change | Standard Deviation 5.01 |
Primary
Percent Change From Baseline in LDL-C
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 6 (n=127,115) | -45.647 percent change | Standard Deviation 9.6969 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 3 (n=126,117) | -43.568 percent change | Standard Deviation 10.2149 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 30 (n=112,94) | -46.631 percent change | Standard Deviation 12.0206 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 12 (n=121,109) | -45.530 percent change | Standard Deviation 10.5112 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 1 (n=131,130) | -34.995 percent change | Standard Deviation 9.73 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 24 (n=111,96) | -46.944 percent change | Standard Deviation 11.949 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 18 (n=116,101) | -47.101 percent change | Standard Deviation 10.5592 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 36/ET (n=123,117) | -43.785 percent change | Standard Deviation 13.5585 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in LDL-C | Month 2 (n=132,122) | -40.371 percent change | Standard Deviation 9.6468 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 36/ET (n=123,117) | -39.863 percent change | Standard Deviation 17.5411 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 12 (n=121,109) | -45.727 percent change | Standard Deviation 13.5336 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 24 (n=111,96) | -46.417 percent change | Standard Deviation 13.8658 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 1 (n=131,130) | -37.516 percent change | Standard Deviation 10.0245 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 2 (n=132,122) | -41.939 percent change | Standard Deviation 10.4816 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 6 (n=127,115) | -43.697 percent change | Standard Deviation 11.1836 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 18 (n=116,101) | -44.818 percent change | Standard Deviation 13.2623 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 30 (n=112,94) | -47.734 percent change | Standard Deviation 12.6696 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in LDL-C | Month 3 (n=126,117) | -44.887 percent change | Standard Deviation 12.753 |
Primary
Percent Change From Baseline in Total Cholesterol
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 2 (n=132,124) | -31.900 percent change | Standard Deviation 8.5025 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 18 (n=116,101) | -37.772 percent change | Standard Deviation 9.7325 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 6 (n=127,115) | -36.889 percent change | Standard Deviation 9.2297 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 24 (n=111,96) | -37.287 percent change | Standard Deviation 9.9578 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 3 (n=127,118) | -34.784 percent change | Standard Deviation 9.4141 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 30 (n=112,95) | -36.662 percent change | Standard Deviation 11.2064 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 12 (n=121,109) | -36.541 percent change | Standard Deviation 9.2486 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 36/ET (n=123,117) | -35.063 percent change | Standard Deviation 12.0345 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Total Cholesterol | Month 1 (n=134,131) | -27.879 percent change | Standard Deviation 8.2639 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 36/ET (n=123,117) | -32.013 percent change | Standard Deviation 14.5 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 1 (n=134,131) | -29.653 percent change | Standard Deviation 8.5987 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 2 (n=132,124) | -33.726 percent change | Standard Deviation 9.2319 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 3 (n=127,118) | -36.126 percent change | Standard Deviation 11.0136 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 6 (n=127,115) | -35.055 percent change | Standard Deviation 10.0273 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 12 (n=121,109) | -36.943 percent change | Standard Deviation 11.9418 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 18 (n=116,101) | -36.634 percent change | Standard Deviation 11.4572 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 24 (n=111,96) | -37.317 percent change | Standard Deviation 12.2461 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Total Cholesterol | Month 30 (n=112,95) | -37.856 percent change | Standard Deviation 12.5116 |
Primary
Percent Change From Baseline in Trigylcerides
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 18 (n=116,102) | -13.113 percent change | Standard Deviation 39.399 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 1 (n=134,131) | -5.950 percent change | Standard Deviation 39.0995 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 2 (n=132,124) | -3.260 percent change | Standard Deviation 42.5136 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 3 (n=127,118) | -8.760 percent change | Standard Deviation 41.1184 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 6 (n=127,115) | -11.817 percent change | Standard Deviation 41.9879 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 12 (n=121,109) | -7.981 percent change | Standard Deviation 40.4511 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 24 (n=111,96) | -6.697 percent change | Standard Deviation 38.7027 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 30 (n=112,95) | 0.657 percent change | Standard Deviation 43.3886 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Trigylcerides | Month 36/ET (n=123,117) | -0.703 percent change | Standard Deviation 50.6333 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 36/ET (n=123,117) | -7.759 percent change | Standard Deviation 45.6372 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 12 (n=121,109) | -7.950 percent change | Standard Deviation 48.7238 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 1 (n=134,131) | -5.927 percent change | Standard Deviation 51.1811 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 18 (n=116,102) | -12.443 percent change | Standard Deviation 37.3822 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 2 (n=132,124) | -14.832 percent change | Standard Deviation 40.4952 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 30 (n=112,95) | -4.935 percent change | Standard Deviation 63.1887 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 3 (n=127,118) | -14.415 percent change | Standard Deviation 39.9951 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 24 (n=111,96) | -7.328 percent change | Standard Deviation 45.3694 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in Trigylcerides | Month 6 (n=127,115) | -9.097 percent change | Standard Deviation 43.035 |
Primary
Percent Change From Baseline in VLDL
Assessments were performed in the fasting state (minimum 10-hour fast).
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 2 (n=132,124) | -3.097 percent change | Standard Deviation 42.3626 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 12 (n=121,109) | -7.739 percent change | Standard Deviation 40.7579 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 3 (n=127,118) | -8.711 percent change | Standard Deviation 41.2631 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 18 (n=116,101) | -12.911 percent change | Standard Deviation 39.7908 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 1 (n=134,131) | -6.060 percent change | Standard Deviation 39.33 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 24 (n=111,96) | -6.654 percent change | Standard Deviation 38.7945 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 6 (n=127,115) | -11.591 percent change | Standard Deviation 42.4219 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 30 (n=112,95) | 0.627 percent change | Standard Deviation 43.6239 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in VLDL | Month 36/ET (n=123,117) | -0.520 percent change | Standard Deviation 51.3422 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 30 (n=112,95) | -4.751 percent change | Standard Deviation 64.2502 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 36/ET (n=123,117) | -7.842 percent change | Standard Deviation 45.464 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 2 (n=132,124) | -14.694 percent change | Standard Deviation 40.171 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 1 (n=134,131) | -5.805 percent change | Standard Deviation 51.7264 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 3 (n=127,118) | -14.263 percent change | Standard Deviation 39.7239 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 6 (n=127,115) | -9.158 percent change | Standard Deviation 43.1397 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 12 (n=121,109) | -7.827 percent change | Standard Deviation 48.9819 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 18 (n=116,101) | -12.768 percent change | Standard Deviation 37.4142 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percent Change From Baseline in VLDL | Month 24 (n=111,96) | -6.920 percent change | Standard Deviation 46.3317 |
Primary
Percent Change From Baseline in Weight: Females
Investigator assessment of weight changes during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 1 (n=125) | 0.97 percent change | Standard Deviation 2.303 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 2 (n=120) | 1.85 percent change | Standard Deviation 3.206 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 3 (n=115) | 3.16 percent change | Standard Deviation 4.149 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 6 (n=113) | 5.37 percent change | Standard Deviation 5.529 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 12 (n=107) | 11.65 percent change | Standard Deviation 8.391 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 18 (n=99) | 16.79 percent change | Standard Deviation 11.315 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 24 (n=95) | 23.43 percent change | Standard Deviation 14.333 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 30 (n=93) | 27.83 percent change | Standard Deviation 17.507 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Females | Month 36/ET (n=121) | 27.26 percent change | Standard Deviation 21.389 |
Primary
Percent Change From Baseline in Weight: Males
Investigator assessment of weight changes during the study.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 1 (n=141) | 0.94 percent change | Standard Deviation 2.739 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 2 (n=138) | 2.04 percent change | Standard Deviation 3.262 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 3 (n=133) | 2.73 percent change | Standard Deviation 4.317 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 6 (n=129) | 5.09 percent change | Standard Deviation 5.559 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 12 (n=123) | 11.85 percent change | Standard Deviation 8.172 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 18 (n=119) | 18.03 percent change | Standard Deviation 9.629 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 24 (n=114) | 24.28 percent change | Standard Deviation 11.696 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 30 (n=114) | 30.46 percent change | Standard Deviation 14.058 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percent Change From Baseline in Weight: Males | Month 36/ET (n=134) | 32.54 percent change | Standard Deviation 17.409 |
Primary
Total Cholesterol (mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 30 (n=112,95) | 5.075 mMol/L | Standard Deviation 0.6951 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 2 (n=132,124) | 5.435 mMol/L | Standard Deviation 0.8629 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 6 (n=127,115) | -3.063 mMol/L | Standard Deviation 1.1687 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Baseline (n=139,132) | 8.056 mMol/L | Standard Deviation 1.3356 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 12 (n=121,109) | 5.081 mMol/L | Standard Deviation 0.747 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 2 (n=132,124) | -2.620 mMol/L | Standard Deviation 0.9581 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 12 (n=121,109) | -3.040 mMol/L | Standard Deviation 1.1353 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -2.923 mMol/L | Standard Deviation 1.3256 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 18 (n=116,101) | 4.989 mMol/L | Standard Deviation 0.6512 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 3 (n=127,118) | 5.195 mMol/L | Standard Deviation 0.8 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 18 (n=116,101) | -3.168 mMol/L | Standard Deviation 1.199 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 1 (n=134,131) | 5.785 mMol/L | Standard Deviation 1.0497 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 24 (n=111,96) | 5.032 mMol/L | Standard Deviation 0.7111 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 3 (n=127,118) | -2.869 mMol/L | Standard Deviation 1.0904 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 24 (n=111,96) | -3.123 mMol/L | Standard Deviation 1.2039 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 1 (n=134,131) | -2.266 mMol/L | Standard Deviation 0.7957 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Change at Month 30 (n=112,95) | -3.096 mMol/L | Standard Deviation 1.2999 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 6 (n=127,115) | 5.019 mMol/L | Standard Deviation 0.638 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Total Cholesterol (mMol/L) During the Study | Month 36/ET (n=123,117) | 5.134 mMol/L | Standard Deviation 0.7863 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 6 (n=127,115) | 4.982 mMol/L | Standard Deviation 0.662 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -2.543 mMol/L | Standard Deviation 1.3669 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 1 (n=134,131) | 5.352 mMol/L | Standard Deviation 0.9345 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Baseline (n=139,132) | 7.647 mMol/L | Standard Deviation 1.225 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 1 (n=134,131) | -2.297 mMol/L | Standard Deviation 0.8516 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 2 (n=132,124) | 5.061 mMol/L | Standard Deviation 0.7865 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 2 (n=132,124) | -2.654 mMol/L | Standard Deviation 0.9707 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 3 (n=127,118) | 4.883 mMol/L | Standard Deviation 0.7034 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 3 (n=127,118) | -2.883 mMol/L | Standard Deviation 1.1363 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 36/ET (n=123,117) | 5.099 mMol/L | Standard Deviation 0.9318 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 30 (n=112,95) | 4.795 mMol/L | Standard Deviation 0.8256 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 6 (n=127,115) | -2.809 mMol/L | Standard Deviation 1.1133 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 12 (n=121,109) | 4.799 mMol/L | Standard Deviation 0.7176 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 12 (n=121,109) | -2.945 mMol/L | Standard Deviation 1.2112 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 18 (n=116,101) | 4.845 mMol/L | Standard Deviation 0.5401 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 18 (n=116,101) | -2.965 mMol/L | Standard Deviation 1.2667 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Month 24 (n=111,96) | 4.817 mMol/L | Standard Deviation 0.7413 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 24 (n=111,96) | -3.009 mMol/L | Standard Deviation 1.2871 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Total Cholesterol (mMol/L) During the Study | Change at Month 30 (n=112,95) | -3.048 mMol/L | Standard Deviation 1.2716 |
Primary
Trigylcerides (mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 6 (n=127,115) | -0.183 mMol/L | Standard Deviation 0.4305 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 24 (n=111,96) | -0.133 mMol/L | Standard Deviation 0.4112 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 12 (n=121,109) | -0.747 mMol/L | Standard Deviation 0.3901 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 1 (n=134,131) | -0.121 mMol/L | Standard Deviation 0.3895 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 12 (n=121,109) | -0.136 mMol/L | Standard Deviation 0.406 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 30 (n=112,95) | 0.788 mMol/L | Standard Deviation 0.3454 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 18 (n=116,102) | 0.687 mMol/L | Standard Deviation 0.3435 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 2 (n=132,124) | 0.772 mMol/L | Standard Deviation 0.3837 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 18 (n=116,102) | -0.190 mMol/L | Standard Deviation 0.3665 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Baseline (n=139,132) | 0.880 mMol/L | Standard Deviation 0.4343 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 24 (n=111,96) | 0.725 mMol/L | Standard Deviation 0.3676 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 2 (n=132,124) | -0.103 mMol/L | Standard Deviation 0.3652 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 6 (n=127,115) | 0.691 mMol/L | Standard Deviation 0.3602 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 30 (n=112,95) | -0.082 mMol/L | Standard Deviation 0.3898 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 3 (n=127,118) | 0.699 mMol/L | Standard Deviation 0.2916 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 36/ET (n=123,117) | 0.764 mMol/L | Standard Deviation 0.422 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Month 1 (n=134,131) | 0.759 mMol/L | Standard Deviation 0.3958 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -0.092 mMol/L | Standard Deviation 0.4615 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Trigylcerides (mMol/L) During the Study | Change at Month 3 (n=127,118) | -0.166 mMol/L | Standard Deviation 0.3937 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -0.171 mMol/L | Standard Deviation 0.5216 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 3 (n=127,118) | -0.237 mMol/L | Standard Deviation 0.4466 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 6 (n=127,115) | 0.801 mMol/L | Standard Deviation 0.3848 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Baseline (n=139,132) | 0.980 mMol/L | Standard Deviation 0.4986 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 1 (n=134,131) | 0.815 mMol/L | Standard Deviation 0.3848 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 1 (n=134,131) | -0.166 mMol/L | Standard Deviation 0.5024 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 2 (n=132,124) | 0.741 mMol/L | Standard Deviation 0.3382 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 2 (n=132,124) | -0.246 mMol/L | Standard Deviation 0.4825 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 3 (n=127,118) | 0.748 mMol/L | Standard Deviation 0.3357 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 6 (n=127,115) | -0.188 mMol/L | Standard Deviation 0.488 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 12 (n=121,109) | 0.789 mMol/L | Standard Deviation 0.405 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 12 (n=121,109) | -0.181 mMol/L | Standard Deviation 0.5255 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 18 (n=116,102) | 0.765 mMol/L | Standard Deviation 0.3438 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 18 (n=116,102) | -0.219 mMol/L | Standard Deviation 0.4623 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 24 (n=111,96) | 0.790 mMol/L | Standard Deviation 0.3651 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 30 (n=112,95) | 0.781 mMol/L | Standard Deviation 0.4167 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 30 (n=112,95) | -0.187 mMol/L | Standard Deviation 0.5728 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Month 36/ET (n=123,117) | 0.794 mMol/L | Standard Deviation 0.3894 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Trigylcerides (mMol/L) During the Study | Change at Month 24 (n=111,96) | -0.179 mMol/L | Standard Deviation 0.4956 |
Primary
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 2 (n=132,124) | 0.354 mMol/L | Standard Deviation 0.1757 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 2 (n=132,124) | -0.047 mMol/L | Standard Deviation 0.1672 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 12 (n=121,109) | 0.343 mMol/L | Standard Deviation 0.1786 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 12 (n=121,109) | -0.062 mMol/L | Standard Deviation 0.1872 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 6 (n=127,115) | 0.317 mMol/L | Standard Deviation 0.1652 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Baseline (n=139,132) | 0.403 mMol/L | Standard Deviation 0.1993 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 1 (n=134,131) | 0.348 mMol/L | Standard Deviation 0.1823 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 1 (n=134,131) | -0.056 mMol/L | Standard Deviation 0.1793 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 3 (n=127,118) | 0.320 mMol/L | Standard Deviation 0.1333 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 3 (n=127,118) | -0.076 mMol/L | Standard Deviation 0.1805 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 6 (n=127,115) | -0.084 mMol/L | Standard Deviation 0.1977 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 18 (n=116,101) | 0.315 mMol/L | Standard Deviation 0.1571 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 18 (n=116,101) | -0.087 mMol/L | Standard Deviation 0.168 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 24 (n=111,96) | 0.332 mMol/L | Standard Deviation 0.168 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 24 (n=111,96) | -0.061 mMol/L | Standard Deviation 0.1887 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 30 (n=112,95) | 0.361 mMol/L | Standard Deviation 0.1581 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 30 (n=112,95) | -0.038 mMol/L | Standard Deviation 0.1781 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 36/ET (n=123,117) | 0.350 mMol/L | Standard Deviation 0.193 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -0.042 mMol/L | Standard Deviation 0.2112 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 24 (n=111,96) | -0.081 mMol/L | Standard Deviation 0.2285 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 2 (n=132,124) | 0.340 mMol/L | Standard Deviation 0.1541 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 12 (n=121,109) | 0.362 mMol/L | Standard Deviation 0.1862 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 6 (n=127,115) | -0.086 mMol/L | Standard Deviation 0.224 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 12 (n=121,109) | -0.082 mMol/L | Standard Deviation 0.2421 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 36/ET (n=123,117) | -0.079 mMol/L | Standard Deviation 0.2385 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 18 (n=116,101) | 0.349 mMol/L | Standard Deviation 0.1571 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 30 (n=112,95) | 0.358 mMol/L | Standard Deviation 0.1914 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Baseline (n=139,132) | 0.449 mMol/L | Standard Deviation 0.2288 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 18 (n=116,101) | -0.102 mMol/L | Standard Deviation 0.2126 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 1 (n=134,131) | 0.374 mMol/L | Standard Deviation 0.177 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 36/ET (n=123,117) | 0.364 mMol/L | Standard Deviation 0.1782 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 1 (n=134,131) | -0.076 mMol/L | Standard Deviation 0.2307 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 2 (n=132,124) | -0.113 mMol/L | Standard Deviation 0.2215 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 24 (n=111,96) | 0.363 mMol/L | Standard Deviation 0.168 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 3 (n=127,118) | 0.344 mMol/L | Standard Deviation 0.1548 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 30 (n=112,95) | -0.086 mMol/L | Standard Deviation 0.2621 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Change at Month 3 (n=127,118) | -0.108 mMol/L | Standard Deviation 0.2044 |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study | Month 6 (n=127,115) | 0.367 mMol/L | Standard Deviation 0.1767 |
Primary
Weight (kg) During the Study: Females
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Baseline (n=125) | 42.14 kg | Standard Deviation 14.038 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 1 (n=125) | 42.50 kg | Standard Deviation 14.007 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 1 (n=125) | 0.36 kg | Standard Deviation 0.924 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 2 (n=120) | 42.86 kg | Standard Deviation 14.209 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 2 (n=120) | 0.67 kg | Standard Deviation 1.338 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 3 (n=115) | 43.34 kg | Standard Deviation 14.753 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 3 (n=115) | 1.24 kg | Standard Deviation 1.819 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 6 (n=113) | 44.26 kg | Standard Deviation 15.027 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 6 (n=113) | 2.10 kg | Standard Deviation 2.409 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 12 (n=107) | 46.61 kg | Standard Deviation 15.158 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 12 (n=107) | 4.41 kg | Standard Deviation 3.317 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 18 (n=99) | 48.32 kg | Standard Deviation 14.67 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 18 (n=99) | 6.24 kg | Standard Deviation 4.291 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 24 (n=95) | 50.13 kg | Standard Deviation 14.731 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 24 (n=95) | 8.55 kg | Standard Deviation 5.038 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 30 (n=93) | 51.73 kg | Standard Deviation 14.681 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 30 (n=93) | 10.02 kg | Standard Deviation 6.127 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Month 36/ET (n=121) | 51.55 kg | Standard Deviation 14.498 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (kg) During the Study: Females | Change at Month 36/ET (n=121) | 9.77 kg | Standard Deviation 7.047 |
Primary
Weight (Kilograms [kg]) During the Study: Males
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Population: FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 6 (n=129) | 42.47 kg | Standard Deviation 14.564 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 6 (n=129) | 2.00 kg | Standard Deviation 2.528 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 12 (n=123) | 45.29 kg | Standard Deviation 15.526 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 12 (n=123) | 4.65 kg | Standard Deviation 3.822 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 18 (n=119) | 47.53 kg | Standard Deviation 16.164 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 18 (n=119) | 7.02 kg | Standard Deviation 4.432 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 24 (n=114) | 49.77 kg | Standard Deviation 16.401 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 24 (n=114) | 9.27 kg | Standard Deviation 5.079 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 30 (n=114) | 52.12 kg | Standard Deviation 17.1 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 30 (n=114) | 11.61 kg | Standard Deviation 6.032 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 36/ET (n=134) | 53.50 kg | Standard Deviation 16.787 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 36/ET (n=134) | 12.35 kg | Standard Deviation 6.771 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Baseline (n=146) | 40.79 kg | Standard Deviation 14.079 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 1 (n=141) | 41.18 kg | Standard Deviation 14.287 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 1 (n=141) | 0.36 kg | Standard Deviation 1.203 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 2 (n=138) | 41.83 kg | Standard Deviation 14.467 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 2 (n=138) | 0.80 kg | Standard Deviation 1.422 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Month 3 (n=133) | 41.68 kg | Standard Deviation 14.266 |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Weight (Kilograms [kg]) During the Study: Males | Change at Month 3 (n=133) | 1.08 kg | Standard Deviation 1.907 |
Secondary
Percentage of Participants by Study Drug Compliance Category
Compliance to study drug was categorized as \<80%, 80% - 120%, and greater than (\>) 120%.
Time frame: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)
Population: Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 24, >120% (n=113,95) | 0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 6, <80% (n=127,115) | 7.9 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 18, <80% (n=116,102) | 4.3 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 1, <80% (n=135,132) | 3.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 1, 80%-120% (n=135,132) | 97.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 1, >120% (n=135,132) | 0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 2, <80% (n=132,126) | 6.8 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 2, 80%-120% (n=132,126) | 92.4 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 2, >120% (n=132,126) | 0.8 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 3, <80% (n=130,118) | 3.8 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 3, 80%-120% (n=130,118) | 95.4 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 3, >120% (n=130,118) | 0.8 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 6, 80%-120% (n=127,115) | 92.1 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 6, >120% (n=127,115) | 0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 12, <80% (n=121,109) | 7.4 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 12, 80%-120% (n=121,109) | 92.6 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 12, >120% (n=121,109) | 0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 18, 80%-120% (n=116,102) | 94.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 18, >120% (n=116,102) | 1.7 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 24, <80% (n=113,95) | 8.8 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 24, 80%-120% (n=113,95) | 91.2 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 30, <80% (n=112,94) | 8.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 30, 80%-120% (n=112,94) | 92.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 30, >120% (n=112,94) | 0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 36/ET, <80% (n=129,129) | 11.6 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 36/ET, 80%-120% (n=129,129) | 86.8 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants by Study Drug Compliance Category | Month 36/ET, >120% (n=129,129) | 1.6 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 3, >120% (n=130,118) | 0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 12, <80% (n=121,109) | 7.3 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 6, <80% (n=127,115) | 9.6 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 24, >120% (n=113,95) | 1.1 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 18, <80% (n=116,102) | 5.9 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 30, >120% (n=112,94) | 1.1 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 12, 80%-120% (n=121,109) | 92.7 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 1, <80% (n=135,132) | 6.8 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 36/ET, 80%-120% (n=129,129) | 83.7 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 1, 80%-120% (n=135,132) | 93.2 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 12, >120% (n=121,109) | 0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 1, >120% (n=135,132) | 0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 30, <80% (n=112,94) | 6.4 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 2, <80% (n=132,126) | 7.9 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 18, 80%-120% (n=116,102) | 94.1 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 2, 80%-120% (n=132,126) | 92.1 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 36/ET, <80% (n=129,129) | 16.3 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 2, >120% (n=132,126) | 0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 18, >120% (n=116,102) | 0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 3, <80% (n=130,118) | 7.6 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 30, 80%-120% (n=112,94) | 92.6 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 3, 80%-120% (n=130,118) | 92.4 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 24, <80% (n=113,95) | 9.5 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 36/ET, >120% (n=129,129) | 0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 6, 80%-120% (n=127,115) | 90.4 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 24, 80%-120% (n=113,95) | 89.5 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants by Study Drug Compliance Category | Month 6, >120% (n=127,115) | 0 percentage of participants |
Secondary
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Time frame: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
Population: FAS; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Baseline (n=139,132) | 99.3 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 1 (n=118,113) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 2 (n=116,109) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 3 (n=130,118) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 6 (n=127,115) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 12 (n=121,109) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 18 (n=115,102) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 24 (n=113,95) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 30 (n=111,94) | 100.0 percentage of participants |
| Atorvastatin (5-80 mg): Tanner_Stage 1 | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 36/Early Termination (n=128,127) | 99.2 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 24 (n=113,95) | 100.0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Baseline (n=139,132) | 100.0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 12 (n=121,109) | 99.1 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 1 (n=118,113) | 100.0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 36/Early Termination (n=128,127) | 99.2 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 2 (n=116,109) | 100.0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 18 (n=115,102) | 100.0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 3 (n=130,118) | 100.0 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 30 (n=111,94) | 98.9 percentage of participants |
| Atorvastatin (10-80 mg): Tanner_Stage 2+ | Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator | Month 6 (n=127,115) | 99.1 percentage of participants |