Familial Hypercholesterolaemia
Conditions
Keywords
Familial Hypercholesterolaemia, pediatric
Brief summary
This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability and efficacy of the study medication in these patients. This study will also measure levels of drug in the blood and see how well it is tolerated. This is known as pharmacokinetic (PK) analysis. At baseline only a small number of patients will participate in a single dose PK phase over 24 hours. In order to see if this medication works, a control group of healthy siblings will help the researchers to compare certain results.
Interventions
5 mg, oral, once daily, 24 months
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* children and adolescents (aged 6 to less than 18 years) with Familial Hypercholesterolaemia * Patients aged between 6 and less than 10 years of age must not be taking a statin medicine
Exclusion criteria
* History of muscle or sensitivity reactions to any statin medicines * Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Dose PK - AUC(0-24) | Serial blood samples over 24 hours | Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing |
| Single Dose PK - Cmax | Serial blood samples over 24 hours. | Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing |
| Percent Change From Baseline in Height | At Month 12 and Month 24 | One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Sexual Maturation by Tanner Staging at Month 12 | At Baseline | Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Sexual Maturation by Tanner Staging at Month 24 | At Baseline | Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Single Dose PK - Tmax | Serial blood samples over 24 hours | Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing |
| Percent Change From Baseline in LDL-C | At Month 3, Month 12 and Month 24 | Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Sexual Maturation by Tanner Staging at Baseline | At Baseline | Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | At Month 12 and Month 24 | One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Adverse Events | 2-year study period | Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Total Duration of Exposure | 2-year study period | Total duration of exposure was calculated as \[last dose date of rosuva - first dose date of rosuva + 1 day\]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Overal Treatment Adherence | 2-year study period | Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
| Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | At Month 3, Month 12 and Month 24 | One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data. |
Countries
Belgium, Canada, Netherlands, Norway, United States
Participant flow
Recruitment details
250 patients with FH were screened. Additionally, 65 healthy siblings (HS) were enrolled. HS refers to healthy subjects that were siblings of either the study participants or other paediatric patients with HeFH that were not participating in the study. HS were enrolled to have assessments of cIMT, but did not participate further.
Participants by arm
| Arm | Count |
|---|---|
| Rosuvastatin Rosuvastatin 5 mg, 10 mg or 20 mg | 198 |
| Healthy Siblings Controls to HeFH patients in the cIMT evaluations | 65 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Protocol Violation | 56 | 0 |
| Overall Study | Provided in CRF for specific reasons | 2 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 3 |
Baseline characteristics
| Characteristic | Healthy Siblings | Total | Rosuvastatin |
|---|---|---|---|
| Age, Continuous Years | 11.5 Years STANDARD_DEVIATION 3.53 | 11.55 Years STANDARD_DEVIATION 3.43 | 11.6 Years STANDARD_DEVIATION 3.33 |
| Race/Ethnicity, Customized Caucasian | 53 Participants | 231 Participants | 178 Participants |
| Race/Ethnicity, Customized non-Caucasian | 12 Participants | 32 Participants | 20 Participants |
| Sex: Female, Male Female | 32 Participants | 142 Participants | 110 Participants |
| Sex: Female, Male Male | 33 Participants | 121 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 172 / 197 |
| serious Total, serious adverse events | 9 / 197 |
Outcome results
Primary
Percent Change From Baseline in Height
One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: At Month 12 and Month 24
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosuvastatin | Percent Change From Baseline in Height | %Change from Baseline at Month 12 | 3.20 Percent change | Standard Deviation 2.023 |
| Rosuvastatin | Percent Change From Baseline in Height | %Change from Baseline at Month 24 | 5.91 Percent change | Standard Deviation 3.968 |
Primary
Percent Change From Baseline in LDL-C
Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: At Month 3, Month 12 and Month 24
Population: Intent-to-treat analysis set and Per-protocol analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosuvastatin | Percent Change From Baseline in LDL-C | LDL-C %Change from Baseline at month 3 | -37.86 Percentage change | Standard Deviation 14.392 |
| Rosuvastatin | Percent Change From Baseline in LDL-C | LDL-C %Change from Baseline at month 12 | -43.67 Percentage change | Standard Deviation 14.896 |
| Rosuvastatin | Percent Change From Baseline in LDL-C | LDL-C %Change from Baseline at month 24 | -42.88 Percentage change | Standard Deviation 18.222 |
p-value: <0.001-42.88% CI: [-45.44, -40.32]ANCOVA
Primary
Sexual Maturation by Tanner Staging at Baseline
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time frame: At Baseline
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosuvastatin | Sexual Maturation by Tanner Staging at Baseline | Tanner Stage I at Baseline | 81 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Baseline | Tanner Stage II at Baseline | 32 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Baseline | Tanner Stage III at Baseline | 18 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Baseline | Tanner Stage IV at Baseline | 44 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Baseline | Tanner Stage V at Baseline | 21 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Baseline | Not Recorded at Baseline | 1 Participants |
Primary
Sexual Maturation by Tanner Staging at Month 12
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time frame: At Baseline
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 12 | Tanner Stage I at Month 12 | 61 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 12 | Tanner Stage II at Month 12 | 31 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 12 | Tanner Stage III at Month 12 | 21 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 12 | Tanner Stage IV at Month 12 | 32 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 12 | Tanner Stage V at Month 12 | 42 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 12 | Not Recorded at Month 12 | 10 Participants |
Primary
Sexual Maturation by Tanner Staging at Month 24
Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time frame: At Baseline
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 24 | Tanner Stage I at Month 24 | 43 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 24 | Tanner Stage II at Month 24 | 33 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 24 | Tanner Stage III at Month 24 | 23 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 24 | Tanner Stage IV at Month 24 | 32 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 24 | Tanner Stage V at Month 24 | 64 Participants |
| Rosuvastatin | Sexual Maturation by Tanner Staging at Month 24 | Not Recorded at Month 24 | 2 Participants |
Primary
Single Dose PK - AUC(0-24)
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Time frame: Serial blood samples over 24 hours
Population: Single dose PK analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Single Dose PK - AUC(0-24) | 27.675 ng*hr/mL | Standard Deviation 26.6417 |
Primary
Single Dose PK - Cmax
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Time frame: Serial blood samples over 24 hours.
Population: Single dose PK analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Single Dose PK - Cmax | 3.5717 ng/mL | Standard Deviation 3.2235 |
Primary
Single Dose PK - Tmax
Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing
Time frame: Serial blood samples over 24 hours
Population: Single dose PK analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Single Dose PK - Tmax | 2.664 hr | Standard Deviation 1.8851 |
Secondary
Adverse Events
Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: 2-year study period
Population: Safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rosuvastatin | Adverse Events | Any AE | 172 Participant |
| Rosuvastatin | Adverse Events | AE Leading to Death | 0 Participant |
| Rosuvastatin | Adverse Events | AE Leading to Discontinuation | 3 Participant |
| Rosuvastatin | Adverse Events | Serious AE | 9 Participant |
| Rosuvastatin | Adverse Events | Treatment Related AE | 29 Participant |
| Rosuvastatin | Adverse Events | Treatment Related AE Leading to Death | 0 Participant |
| Rosuvastatin | Adverse Events | Treatment Related AE Leading to Discontinuation | 3 Participant |
| Rosuvastatin | Adverse Events | Treatment Related Serious AE | 0 Participant |
Secondary
Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT)
One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: At Month 12 and Month 24
Population: Intent-to-treat analysis set (LOCF) and healthy siblings
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosuvastatin | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Max cIMT Change from Baseline at Month 12 | 0.00626 mm | Standard Deviation 0.073446 |
| Rosuvastatin | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Max cIMT Change from Baseline at Month 24 | 0.00189 mm | Standard Deviation 0.060864 |
| Rosuvastatin | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Mean cIMT Change from Baseline at Month 12 | 0.00282 mm | Standard Deviation 0.041186 |
| Rosuvastatin | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Mean cIMT Change from Baseline at Month 24 | 0.01056 mm | Standard Deviation 0.040762 |
| Healthy Siblings | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Mean cIMT Change from Baseline at Month 24 | 0.02779 mm | Standard Deviation 0.031004 |
| Healthy Siblings | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Max cIMT Change from Baseline at Month 12 | 0.01707 mm | Standard Deviation 0.056223 |
| Healthy Siblings | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Mean cIMT Change from Baseline at Month 12 | 0.01564 mm | Standard Deviation 0.032052 |
| Healthy Siblings | Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT) | Max cIMT Change from Baseline at Month 24 | 0.01202 mm | Standard Deviation 0.049102 |
Secondary
Overal Treatment Adherence
Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: 2-year study period
Population: Safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Overal Treatment Adherence | 89.6 Percent of doses | Standard Deviation 12.25 |
Secondary
Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1
One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: At Month 3, Month 12 and Month 24
Population: Intent-to-treat analysis set (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | HDL-C %Change from Baseline at Month 3 | 5.67 Percent change | Standard Deviation 17.445 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | HDL-C %Change from Baseline at Month 12 | 6.35 Percent change | Standard Deviation 16.725 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | HDL-C %Change from Baseline at Month 24 | 11.73 Percent change | Standard Deviation 19.996 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | TC %Change from Baseline at Month 3 | -29.60 Percent change | Standard Deviation 11.433 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | TC %Change from Baseline at Month 12 | -33.91 Percent change | Standard Deviation 12.05 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | TC %Change from Baseline at Month 24 | -32.03 Percent change | Standard Deviation 14.53 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | Triglycerides %Change from Baseline at Month 3 | -7.95 Percent change | Standard Deviation 34.482 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | Triglycerides %Change from Baseline at Month 12 | -7.85 Percent change | Standard Deviation 37.53 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | Triglycerides %Change from Baseline at Month 24 | -0.12 Percent change | Standard Deviation 37.682 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | non-HDL C %Change from Baseline at Month 3 | -36.35 Percent change | Standard Deviation 13.368 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | non-HDL C %Change from Baseline at Month 12 | -41.66 Percent change | Standard Deviation 14.235 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | non-HDL C %Change from Baseline at Month 24 | -40.40 Percent change | Standard Deviation 17.555 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | LDL-C/HDL-C %Change from Baseline at Month 3 | -39.66 Percent change | Standard Deviation 17.381 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | LDL-C/HDL-C %Change from Baseline at Month 12 | -45.63 Percent change | Standard Deviation 17.082 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | LDL-C/HDL-C %Change from Baseline at Month 24 | -46.95 Percent change | Standard Deviation 20.126 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | TC/HDL-C %Change from Baseline at Month 3 | -31.77 Percent change | Standard Deviation 14.874 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | TC/HDL-C %Change from Baseline at Month 12 | -36.54 Percent change | Standard Deviation 14.474 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | TC/HDL-C %Change from Baseline at Month 24 | -37.39 Percent change | Standard Deviation 17.079 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | Trig/HDL-C %Change from Baseline at Month 3 | -9.05 Percent change | Standard Deviation 41.765 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | Trig/HDL-C %Change from Baseline at Month 12 | -10.50 Percent change | Standard Deviation 40.633 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | Trig/HDL-C %Change from Baseline at Month 24 | -7.12 Percent change | Standard Deviation 40.585 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | non-HDL-C/HDL-C %Change from Baseline at Month 3 | -37.98 Percent change | Standard Deviation 17.369 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | non-HDL-C/HDL-C %Change from Baseline at Month 12 | -43.71 Percent change | Standard Deviation 16.731 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | non-HDL-C/HDL-C %Change from Baseline at Month 24 | -44.74 Percent change | Standard Deviation 19.896 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoA-I %Change from Baseline at Month 3 | 4.77 Percent change | Standard Deviation 14.68 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoA-I %Change from Baseline at Month 12 | 1.41 Percent change | Standard Deviation 13.747 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoA-I %Change from Baseline at Month 24 | 2.34 Percent change | Standard Deviation 15.027 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoB %Change from Baseline at Month 3 | -29.29 Percent change | Standard Deviation 12.456 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoB %Change from Baseline at Month 12 | -35.65 Percent change | Standard Deviation 12.424 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoB %Change from Baseline at Month 24 | -35.72 Percent change | Standard Deviation 15.71 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoB/ApoA-I %Change from Baseline at Month 3 | -31.30 Percent change | Standard Deviation 15.524 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoB/ApoA-I %Change from Baseline at Month 12 | -35.66 Percent change | Standard Deviation 13.92 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | ApoB/ApoA-I %Change from Baseline at Month 24 | -35.94 Percent change | Standard Deviation 18.743 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | hsCRP %Change from Baseline at Month 3 | 512.57 Percent change | Standard Deviation 4724.249 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | hsCRP %Change from Baseline at Month 12 | 42.96 Percent change | Standard Deviation 226.954 |
| Rosuvastatin | Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1 | hsCRP %Change from Baseline at Month 24 | 98.36 Percent change | Standard Deviation 565.444 |
Secondary
Total Duration of Exposure
Total duration of exposure was calculated as \[last dose date of rosuva - first dose date of rosuva + 1 day\]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.
Time frame: 2-year study period
Population: Safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin | Total Duration of Exposure | 703.5 Days | Standard Deviation 97.25 |