Pediatric Heterozygous Hypercholesterolemia
Conditions
Keywords
heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric
Brief summary
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
Interventions
DRUGAtorvastatin
6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (\<3.35 mmol/L) after 4-week treatment.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Genetically confirmed heterozygous familial hypercholesterolemia (HeFH) with LDL greater or equal 4 mmol/L at baseline
Exclusion criteria
* Evidence or history of clinically significant diseases, homozygous familial hypercholesterolemia (FH)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) | Week 2, Week 4, Week 6, Week 8 | Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used. |
| Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F) | Week 2, Week 4, Week 6, Week 8 | Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Total Cholesterol (TC) | Baseline, Week 2, Week 4, Week 6, Week 8 | Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value. |
| Percent Change From Baseline in Total Cholesterol (TC) | Baseline, Week 2, Week 4, Week 6, Week 8 | Total cholesterol (TC): percent (%) change from baseline by treatment over time = \[TC at observation minus TC at Week 0\] divided by TC at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Absolute Change From Baseline in Triglycerides (TG) | Baseline, Week 2, Week 4, Week 6, Week 8 | Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value. |
| Percent Change From Baseline in Triglycerides (TG) | Baseline, Week 2, Week 4, Week 6, Week 8 | Triglycerides (TG): percent (%) change from baseline by treatment over time = \[TG at observation minus TG at Week 0\] divided by TG at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline, Week 2, Week 4, Week 6, Week 8 | Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value. |
| Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline, Week 2, Week 4, Week 6, Week 8 | High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = \[HDL-C at observation minus HDL-C at Week 0\] divided by HDL-C at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Baseline, Week 2, Week 4, Week 6, Week 8 | Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value. |
| Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline, Week 2, Week 4, Week 6, Week 8 | Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value. |
| Absolute Change From Baseline in Apolipoprotein B (Apo B) | Baseline, Week 2, Week 4, Week 6, Week 8 | Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value. |
| Percent Change From Baseline in Apolipoprotein B (Apo B) | Baseline, Week 2, Week 4, Week 6, Week 8 | Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = \[Apo B at observation minus Apo B at Week 0\] divided by Apo B at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Baseline, Week 2, Week 4, Week 6, Week 8 | Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Baseline, Week 2, Week 4, Week 6, Week 8 | Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = \[VLDL-C at observation minus VLDL-C at Week 0\] divided by VLDL-C at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Baseline, Week 8 | Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value. |
| Percent Change From Baseline in Flow-Mediated Dilatation at Week 8 | Baseline, Week 8 | Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. . |
| Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Baseline, Week 2, Week 4, Week 6, Week 8 | Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = \[Apo A-1 at observation minus Apo A-1 at Week 0\] divided by Apo A-1 at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
| Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline, Week 2, Week 4, Week 6, Week 8 | Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = \[LDL-C at observation minus LDL-C at Week 0\] divided by LDL-C at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). |
Countries
Canada, Greece, Norway
Participant flow
Recruitment details
Subjects were enrolled at 3 medical centers and participated in the study between 02 December 2008 and 13 May 2009.
Pre-assignment details
Forty-five subjects were screened, and 39 subjects were assigned to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated. | 15 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated. | 24 |
| Total | 39 |
Baseline characteristics
| Characteristic | Total | Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ |
|---|---|---|---|
| Age, Customized 11-14 years | 16 participants | 2 participants | 14 participants |
| Age, Customized 15-17 years | 7 participants | 0 participants | 7 participants |
| Age, Customized 6-8 years | 7 participants | 7 participants | 0 participants |
| Age, Customized 9-10 years | 9 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 19 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 15 | 13 / 24 |
| serious Total, serious adverse events | 0 / 15 | 0 / 24 |
Outcome results
Primary
Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)
Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.
Time frame: Week 2, Week 4, Week 6, Week 8
Population: Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as \> 80% of samples were below detectable level at the doses used in this trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F) | 1020 liters |
Primary
Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)
Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.
Time frame: Week 2, Week 4, Week 6, Week 8
Population: Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as \> 80% of samples were below detectable level at the doses used in this trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) | 553 L/hr |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) | 543 L/hr |
Comparison: Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.95% CI: [570, 881]non-linear mixed-effects model
Secondary
Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)
Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -0.14 g/L | Standard Deviation 0.18 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | 0.01 g/L | Standard Deviation 0.17 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -0.03 g/L | Standard Deviation 0.12 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | -0.09 g/L | Standard Deviation 0.14 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Baseline | 1.42 g/L | Standard Deviation 0.2 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | -0.06 g/L | Standard Deviation 0.13 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -0.02 g/L | Standard Deviation 0.11 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -0.05 g/L | Standard Deviation 0.13 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | -0.08 g/L | Standard Deviation 0.23 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Baseline | 1.45 g/L | Standard Deviation 0.2 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | -0.06 g/L | Standard Deviation 0.21 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Baseline | 1.29 g/L | Standard Deviation 0.2 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | -0.09 g/L | Standard Deviation 0.22 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -0.07 g/L | Standard Deviation 0.19 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -0.04 g/L | Standard Deviation 0.24 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -0.04 g/L | Standard Deviation 0.23 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | -0.01 g/L | Standard Deviation 0.15 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Baseline | 1.24 g/L | Standard Deviation 0.15 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | 0.07 g/L | Standard Deviation 0.29 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -0.07 g/L | Standard Deviation 0.21 |
Secondary
Absolute Change From Baseline in Apolipoprotein B (Apo B)
Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -0.27 g/L | Standard Deviation 0.15 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -0.23 g/L | Standard Deviation 0.13 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -0.30 g/L | Standard Deviation 0.08 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -0.33 g/L | Standard Deviation 0.11 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Baseline | 1.09 g/L | Standard Deviation 0.13 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -0.40 g/L | Standard Deviation 0.13 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -0.53 g/L | Standard Deviation 0.17 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -0.59 g/L | Standard Deviation 0.15 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -0.31 g/L | Standard Deviation 0.19 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Baseline | 1.49 g/L | Standard Deviation 0.24 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -0.44 g/L | Standard Deviation 0.1 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Baseline | 1.26 g/L | Standard Deviation 0.14 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -0.39 g/L | Standard Deviation 0.14 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -0.42 g/L | Standard Deviation 0.15 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -0.41 g/L | Standard Deviation 0.17 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -0.52 g/L | Standard Deviation 0.18 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -0.42 g/L | Standard Deviation 0.16 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Baseline | 1.52 g/L | Standard Deviation 0.18 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -0.47 g/L | Standard Deviation 0.22 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -0.49 g/L | Standard Deviation 0.3 |
Secondary
Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8
Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 8
Population: PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Baseline | 4.34 FMD | Standard Deviation 3.15 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Week 8 | -0.16 FMD | Standard Deviation 2.32 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Week 8 | -1.14 FMD | Standard Deviation 1.47 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Baseline | 7.41 FMD | Standard Deviation 3.3 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Baseline | 5.05 FMD | Standard Deviation 3.86 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Week 8 | -0.32 FMD | Standard Deviation 4.83 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Baseline | 3.67 FMD | Standard Deviation 2.51 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8 | Week 8 | 1.35 FMD | Standard Deviation 2.73 |
Secondary
Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | -0.12 mmol/L | Standard Deviation 0.29 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | 0.08 mmol/L | Standard Deviation 0.24 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | 0.04 mmol/L | Standard Deviation 0.22 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | -0.02 mmol/L | Standard Deviation 0.05 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline | 1.35 mmol/L | Standard Deviation 0.12 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | 0.00 mmol/L | Standard Deviation 0.19 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | -0.01 mmol/L | Standard Deviation 0.18 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | -0.07 mmol/L | Standard Deviation 0.21 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | -0.10 mmol/L | Standard Deviation 0.29 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline | 1.45 mmol/L | Standard Deviation 0.29 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | 0.02 mmol/L | Standard Deviation 0.21 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline | 1.17 mmol/L | Standard Deviation 0.18 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | -0.05 mmol/L | Standard Deviation 0.26 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | 0.04 mmol/L | Standard Deviation 0.14 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | 0.08 mmol/L | Standard Deviation 0.25 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | -0.03 mmol/L | Standard Deviation 0.23 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | -0.01 mmol/L | Standard Deviation 0.2 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline | 1.18 mmol/L | Standard Deviation 0.23 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | -0.01 mmol/L | Standard Deviation 0.28 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | -0.08 mmol/L | Standard Deviation 0.22 |
Secondary
Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)
Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: Pharmacodynamic (PD) analysis population: all enrolled subjects who received ≥ 1 dose of study drug and had ≥ 1 PD parameter measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -1.89 mmol/L | Standard Deviation 0.42 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -1.75 mmol/L | Standard Deviation 0.72 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -1.80 mmol/L | Standard Deviation 0.63 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -2.07 mmol/L | Standard Deviation 0.5 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline | 4.87 mmol/L | Standard Deviation 0.48 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -1.94 mmol/L | Standard Deviation 0.56 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -2.57 mmol/L | Standard Deviation 0.7 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -2.71 mmol/L | Standard Deviation 0.6 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -1.62 mmol/L | Standard Deviation 0.46 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline | 6.37 mmol/L | Standard Deviation 1.1 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -2.24 mmol/L | Standard Deviation 0.57 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline | 5.11 mmol/L | Standard Deviation 0.65 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -1.95 mmol/L | Standard Deviation 0.52 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -2.12 mmol/L | Standard Deviation 0.74 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -1.99 mmol/L | Standard Deviation 0.58 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -2.55 mmol/L | Standard Deviation 1.02 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -1.90 mmol/L | Standard Deviation 0.72 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Baseline | 6.23 mmol/L | Standard Deviation 1 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -2.27 mmol/L | Standard Deviation 1.04 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -2.60 mmol/L | Standard Deviation 1.01 |
Secondary
Absolute Change From Baseline in Total Cholesterol (TC)
Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Total Cholesterol (TC) | Week 6 | -2.03 mmol/L | Standard Deviation 0.53 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Total Cholesterol (TC) | Week 2 | -1.89 mmol/L | Standard Deviation 0.79 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Total Cholesterol (TC) | Week 8 | -1.89 mmol/L | Standard Deviation 0.44 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Total Cholesterol (TC) | Week 4 | -2.27 mmol/L | Standard Deviation 0.63 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Total Cholesterol (TC) | Baseline | 6.76 mmol/L | Standard Deviation 0.46 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 4 | -2.24 mmol/L | Standard Deviation 0.49 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 6 | -2.86 mmol/L | Standard Deviation 0.79 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 8 | -3.20 mmol/L | Standard Deviation 0.65 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 2 | -2.04 mmol/L | Standard Deviation 0.69 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Baseline | 8.58 mmol/L | Standard Deviation 1.06 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 4 | -2.37 mmol/L | Standard Deviation 0.61 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Baseline | 6.92 mmol/L | Standard Deviation 0.71 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 2 | -2.11 mmol/L | Standard Deviation 0.53 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 6 | -2.28 mmol/L | Standard Deviation 0.73 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 8 | -2.26 mmol/L | Standard Deviation 0.69 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 6 | -2.95 mmol/L | Standard Deviation 1.19 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 2 | -2.28 mmol/L | Standard Deviation 0.82 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Baseline | 8.40 mmol/L | Standard Deviation 1.1 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 4 | -2.66 mmol/L | Standard Deviation 1.29 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Total Cholesterol (TC) | Week 8 | -3.22 mmol/L | Standard Deviation 1.14 |
Secondary
Absolute Change From Baseline in Triglycerides (TG)
Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]). Change from baseline = value at observation minus baseline value.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Triglycerides (TG) | Week 6 | 0.40 mmol/L | Standard Deviation 0.62 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Triglycerides (TG) | Week 2 | 0.05 mmol/L | Standard Deviation 0.34 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Triglycerides (TG) | Week 8 | 0.02 mmol/L | Standard Deviation 0.28 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Triglycerides (TG) | Week 4 | -0.05 mmol/L | Standard Deviation 0.29 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Triglycerides (TG) | Baseline | 0.76 mmol/L | Standard Deviation 0.15 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 4 | -0.26 mmol/L | Standard Deviation 0.3 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 6 | -0.04 mmol/L | Standard Deviation 0.24 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 8 | -0.16 mmol/L | Standard Deviation 0.37 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 2 | -0.08 mmol/L | Standard Deviation 0.28 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Baseline | 0.95 mmol/L | Standard Deviation 0.27 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 4 | -0.10 mmol/L | Standard Deviation 0.51 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Baseline | 1.03 mmol/L | Standard Deviation 0.37 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 2 | 0.05 mmol/L | Standard Deviation 0.68 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 6 | -0.12 mmol/L | Standard Deviation 0.42 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 8 | -0.31 mmol/L | Standard Deviation 0.43 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 6 | -0.04 mmol/L | Standard Deviation 0.32 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 2 | 0.00 mmol/L | Standard Deviation 0.47 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Baseline | 1.20 mmol/L | Standard Deviation 0.5 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 4 | -0.10 mmol/L | Standard Deviation 0.37 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Triglycerides (TG) | Week 8 | -0.28 mmol/L | Standard Deviation 0.41 |
Secondary
Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)
Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -0.01 mmol/L | Standard Deviation 0.17 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -0.22 mmol/L | Standard Deviation 0.12 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -0.13 mmol/L | Standard Deviation 0.32 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -0.18 mmol/L | Standard Deviation 0.24 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Baseline | 0.54 mmol/L | Standard Deviation 0.15 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -0.30 mmol/L | Standard Deviation 0.27 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -0.28 mmol/L | Standard Deviation 0.32 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -0.42 mmol/L | Standard Deviation 0.28 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -0.31 mmol/L | Standard Deviation 0.38 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Baseline | 0.76 mmol/L | Standard Deviation 0.3 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -0.14 mmol/L | Standard Deviation 0.24 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Baseline | 0.65 mmol/L | Standard Deviation 0.11 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -0.12 mmol/L | Standard Deviation 0.29 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -0.20 mmol/L | Standard Deviation 0.17 |
| Stayed at 10 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -0.35 mmol/L | Standard Deviation 0.14 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -0.36 mmol/L | Standard Deviation 0.28 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -0.38 mmol/L | Standard Deviation 0.33 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Baseline | 0.99 mmol/L | Standard Deviation 0.31 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -0.39 mmol/L | Standard Deviation 0.35 |
| Titrated to 20 mg: Tanner Stage 2+ | Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -0.55 mmol/L | Standard Deviation 0.32 |
Secondary
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)
Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = \[Apo A-1 at observation minus Apo A-1 at Week 0\] divided by Apo A-1 at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | 1.69 percent change in Apo A-1 | Standard Deviation 11.21 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | -5.15 percent change in Apo A-1 | Standard Deviation 8.2 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -9.90 percent change in Apo A-1 | Standard Deviation 14.01 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -1.24 percent change in Apo A-1 | Standard Deviation 8.49 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | -3.30 percent change in Apo A-1 | Standard Deviation 8.11 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -0.97 percent change in Apo A-1 | Standard Deviation 7.04 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -3.37 percent change in Apo A-1 | Standard Deviation 9.35 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | -5.24 percent change in Apo A-1 | Standard Deviation 15.86 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -4.21 percent change in Apo A-1 | Standard Deviation 14.81 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | -3.73 percent change in Apo A-1 | Standard Deviation 16.43 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -2.60 percent change in Apo A-1 | Standard Deviation 20.22 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | -5.96 percent change in Apo A-1 | Standard Deviation 16.76 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 8 | -4.82 percent change in Apo A-1 | Standard Deviation 16.13 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 4 | 7.54 percent change in Apo A-1 | Standard Deviation 25.24 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 2 | -0.53 percent change in Apo A-1 | Standard Deviation 11.9 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) | Week 6 | -2.82 percent change in Apo A-1 | Standard Deviation 18.2 |
Secondary
Percent Change From Baseline in Apolipoprotein B (Apo B)
Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = \[Apo B at observation minus Apo B at Week 0\] divided by Apo B at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -21.92 percent change in Apo B | Standard Deviation 13.97 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -29.89 percent change in Apo B | Standard Deviation 8.94 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -24.58 percent change in Apo B | Standard Deviation 12.96 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -27.39 percent change in Apo B | Standard Deviation 5.97 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -26.56 percent change in Apo B | Standard Deviation 5.33 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -35.26 percent change in Apo B | Standard Deviation 6.85 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -39.59 percent change in Apo B | Standard Deviation 5.83 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -19.88 percent change in Apo B | Standard Deviation 10.96 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -33.26 percent change in Apo B | Standard Deviation 10.38 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -34.69 percent change in Apo B | Standard Deviation 6.1 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -31.94 percent change in Apo B | Standard Deviation 11.64 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -30.81 percent change in Apo B | Standard Deviation 10.27 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 8 | -31.26 percent change in Apo B | Standard Deviation 18.57 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 4 | -30.42 percent change in Apo B | Standard Deviation 11.86 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 2 | -27.46 percent change in Apo B | Standard Deviation 8.89 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Apolipoprotein B (Apo B) | Week 6 | -33.61 percent change in Apo B | Standard Deviation 9.59 |
Secondary
Percent Change From Baseline in Flow-Mediated Dilatation at Week 8
Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. .
Time frame: Baseline, Week 8
Population: PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Flow-Mediated Dilatation at Week 8 | -17.19 percent change in FMD | Standard Deviation 23.67 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Flow-Mediated Dilatation at Week 8 | -20.77 percent change in FMD | Standard Deviation 37.03 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Flow-Mediated Dilatation at Week 8 | -9.77 percent change in FMD | Standard Deviation 63.2 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Flow-Mediated Dilatation at Week 8 | 1.49 percent change in FMD | Standard Deviation 28.64 |
Secondary
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = \[HDL-C at observation minus HDL-C at Week 0\] divided by HDL-C at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | 5.38 percent change in HDL-C | Standard Deviation 17.32 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | -1.99 percent change in HDL-C | Standard Deviation 3.9 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | -10.18 percent change in HDL-C | Standard Deviation 22.7 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | 2.50 percent change in HDL-C | Standard Deviation 15.02 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | 1.59 percent change in HDL-C | Standard Deviation 13.18 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | -0.64 percent change in HDL-C | Standard Deviation 10.35 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | -2.84 percent change in HDL-C | Standard Deviation 14.49 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | -6.45 percent change in HDL-C | Standard Deviation 21.01 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | 3.28 percent change in HDL-C | Standard Deviation 11.63 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | 1.04 percent change in HDL-C | Standard Deviation 17.38 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | 5.99 percent change in HDL-C | Standard Deviation 21.02 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | -4.11 percent change in HDL-C | Standard Deviation 19.96 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 8 | -5.19 percent change in HDL-C | Standard Deviation 17.76 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 4 | 1.77 percent change in HDL-C | Standard Deviation 23.22 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 2 | -0.77 percent change in HDL-C | Standard Deviation 17.66 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Week 6 | -2.78 percent change in HDL-C | Standard Deviation 21.49 |
Secondary
Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)
Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = \[LDL-C at observation minus LDL-C at Week 0\] divided by LDL-C at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -36.27 percent change in LDL-C | Standard Deviation 14.72 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -42.33 percent change in LDL-C | Standard Deviation 8.24 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -38.87 percent change in LDL-C | Standard Deviation 7.84 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -36.78 percent change in LDL-C | Standard Deviation 11.16 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -30.27 percent change in LDL-C | Standard Deviation 5.72 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -40.01 percent change in LDL-C | Standard Deviation 6.34 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -42.70 percent change in LDL-C | Standard Deviation 6.45 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -25.70 percent change in LDL-C | Standard Deviation 7.76 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -41.22 percent change in LDL-C | Standard Deviation 11.34 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -43.66 percent change in LDL-C | Standard Deviation 7.78 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -38.45 percent change in LDL-C | Standard Deviation 7.84 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -38.14 percent change in LDL-C | Standard Deviation 9.35 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 8 | -40.39 percent change in LDL-C | Standard Deviation 11.71 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 4 | -35.13 percent change in LDL-C | Standard Deviation 12.01 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 2 | -30.27 percent change in LDL-C | Standard Deviation 9.22 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C) | Week 6 | -39.73 percent change in LDL-C | Standard Deviation 10.4 |
Secondary
Percent Change From Baseline in Total Cholesterol (TC)
Total cholesterol (TC): percent (%) change from baseline by treatment over time = \[TC at observation minus TC at Week 0\] divided by TC at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Total Cholesterol (TC) | Week 6 | -29.99 percent change in TC | Standard Deviation 8 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Total Cholesterol (TC) | Week 8 | -27.80 percent change in TC | Standard Deviation 5.56 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Total Cholesterol (TC) | Week 4 | -33.37 percent change in TC | Standard Deviation 7.81 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Total Cholesterol (TC) | Week 2 | -28.06 percent change in TC | Standard Deviation 11.23 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 4 | -26.12 percent change in TC | Standard Deviation 4.24 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 2 | -24.11 percent change in TC | Standard Deviation 8.97 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 6 | -33.12 percent change in TC | Standard Deviation 6.83 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 8 | -37.17 percent change in TC | Standard Deviation 5.28 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 6 | -32.80 percent change in TC | Standard Deviation 8.97 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 2 | -30.60 percent change in TC | Standard Deviation 7.49 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 4 | -33.98 percent change in TC | Standard Deviation 7.13 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 8 | -32.43 percent change in TC | Standard Deviation 8.53 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 4 | -30.54 percent change in TC | Standard Deviation 11.6 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 2 | -26.78 percent change in TC | Standard Deviation 7.59 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 8 | -37.45 percent change in TC | Standard Deviation 9.89 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Total Cholesterol (TC) | Week 6 | -34.06 percent change in TC | Standard Deviation 9.94 |
Secondary
Percent Change From Baseline in Triglycerides (TG)
Triglycerides (TG): percent (%) change from baseline by treatment over time = \[TG at observation minus TG at Week 0\] divided by TG at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Triglycerides (TG) | Week 2 | 5.66 percent change in TG | Standard Deviation 38.26 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Triglycerides (TG) | Week 4 | -6.20 percent change in TG | Standard Deviation 32.55 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Triglycerides (TG) | Week 6 | 57.06 percent change in TG | Standard Deviation 78.73 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Triglycerides (TG) | Week 8 | 1.69 percent change in TG | Standard Deviation 31.48 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 4 | -21.43 percent change in TG | Standard Deviation 30.42 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 6 | -1.27 percent change in TG | Standard Deviation 23.91 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 8 | -9.88 percent change in TG | Standard Deviation 33.31 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 2 | -6.87 percent change in TG | Standard Deviation 29.08 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 6 | -4.43 percent change in TG | Standard Deviation 32.52 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 4 | 1.27 percent change in TG | Standard Deviation 50.81 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 8 | -20.94 percent change in TG | Standard Deviation 39.24 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 2 | 28.37 percent change in TG | Standard Deviation 85.32 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 8 | -21.11 percent change in TG | Standard Deviation 23.85 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 4 | -7.60 percent change in TG | Standard Deviation 25.75 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 2 | -0.56 percent change in TG | Standard Deviation 32.19 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Triglycerides (TG) | Week 6 | -2.72 percent change in TG | Standard Deviation 24.8 |
Secondary
Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)
Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = \[VLDL-C at observation minus VLDL-C at Week 0\] divided by VLDL-C at Week 0 \* 100. Assessments were performed in the fasting state (minimum 10-hour fast \[optional at Weeks 2 and 6\]).
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8
Population: PD analysis population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -42.20 percent change in VLDL-C | Standard Deviation 25.17 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -30.66 percent change in VLDL-C | Standard Deviation 48.66 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | 4.10 percent change in VLDL-C | Standard Deviation 36.46 |
| Atorvastatin (5 mg, 10 mg): Tanner Stage 1 | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -12.31 percent change in VLDL-C | Standard Deviation 57.38 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -31.86 percent change in VLDL-C | Standard Deviation 37.62 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -25.59 percent change in VLDL-C | Standard Deviation 44.9 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -50.29 percent change in VLDL-C | Standard Deviation 21.44 |
| Atorvastatin (10 mg, 20 mg): Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -28.49 percent change in VLDL-C | Standard Deviation 43.5 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -29.20 percent change in VLDL-C | Standard Deviation 25.11 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -21.10 percent change in VLDL-C | Standard Deviation 37.56 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -53.61 percent change in VLDL-C | Standard Deviation 19.21 |
| Stayed at 10 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -14.50 percent change in VLDL-C | Standard Deviation 41.19 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 8 | -52.38 percent change in VLDL-C | Standard Deviation 29.34 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 4 | -36.35 percent change in VLDL-C | Standard Deviation 28.79 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 2 | -39.95 percent change in VLDL-C | Standard Deviation 37.24 |
| Titrated to 20 mg: Tanner Stage 2+ | Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) | Week 6 | -35.08 percent change in VLDL-C | Standard Deviation 25.06 |