Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Conditions
Keywords
Atherosclerosis
Brief summary
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Interventions
None listed
Sponsors
Organon and Co
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation | Up to 14 days after the treatment discontinuation | Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment. |
| Mean Percent Change From Baseline to Treatment in Lipid Parameters | Baseline and up to 5 years | The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\[TG\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VYTORIN® 10/10 mg/Day to 10/80 mg/Day Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6. | 2,011 |
| Total | 2,011 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Participants for Efficacy Evaluation | Efficacy evaluation window violation | 2 |
| Participants for Efficacy Evaluation | Lack of tmt period (<28 days) | 61 |
| Participants for Efficacy Evaluation | No efficacy evaluation | 19 |
| Participants for Safety Evaluation | Duplicate Participants | 4 |
| Participants for Safety Evaluation | Off-label use | 9 |
| Participants for Safety Evaluation | TMT given before date of contract | 3 |
| Participants for Safety Evaluation | Violation inclusion criteria/off label | 3 |
| Participants for Safety Evaluation | Violation of inclusion criteria | 59 |
Baseline characteristics
| Characteristic | VYTORIN® 10/10 mg/Day to 10/80 mg/Day |
|---|---|
| Age, Customized 10 ≤age <20 | 5 Participants |
| Age, Customized 20 ≤age <30 | 22 Participants |
| Age, Customized 30 ≤age <40 | 111 Participants |
| Age, Customized 40 ≤age <50 | 391 Participants |
| Age, Customized 50 ≤age <60 | 598 Participants |
| Age, Customized 60 ≤age <70 | 600 Participants |
| Age, Customized 70 ≤age <80 | 256 Participants |
| Age, Customized 80 ≤age <90 | 28 Participants |
| Sex/Gender, Customized Female | 1081 participants |
| Sex/Gender, Customized Male | 930 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 933 | 0 / 531 | 0 / 380 | 0 / 158 |
| serious Total, serious adverse events | 0 / 9 | 4 / 933 | 6 / 531 | 0 / 380 | 5 / 158 |
Outcome results
Primary
Mean Percent Change From Baseline to Treatment in Lipid Parameters
The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\[TG\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.
Time frame: Baseline and up to 5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Treated With VYTORIN | Mean Percent Change From Baseline to Treatment in Lipid Parameters | LDL (n = 1096, 1128, 1012) | 151.32 percentage change | Standard Deviation 39.09 |
| Participants Treated With VYTORIN | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TC (n = 1965, 1993, 1956) | 231.31 percentage change | Standard Deviation 46.33 |
| Participants Treated With VYTORIN | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TG (n = 1843, 1824, 1766) | 200.07 percentage change | Standard Deviation 128.76 |
| Participants Treated With VYTORIN | Mean Percent Change From Baseline to Treatment in Lipid Parameters | HDL (n = 1805, 1782, 1705) | 49.64 percentage change | Standard Deviation 13.42 |
| Participants Treatment Lipid Parameters | Mean Percent Change From Baseline to Treatment in Lipid Parameters | LDL (n = 1096, 1128, 1012) | 104.34 percentage change | Standard Deviation 37.09 |
| Participants Treatment Lipid Parameters | Mean Percent Change From Baseline to Treatment in Lipid Parameters | HDL (n = 1805, 1782, 1705) | 49.85 percentage change | Standard Deviation 13.17 |
| Participants Treatment Lipid Parameters | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TG (n = 1843, 1824, 1766) | 168.33 percentage change | Standard Deviation 102.82 |
| Participants Treatment Lipid Parameters | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TC (n = 1965, 1993, 1956) | 173.00 percentage change | Standard Deviation 40.78 |
| Participants Percent Change | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TG (n = 1843, 1824, 1766) | -7.37 percentage change | Standard Deviation 41.99 |
| Participants Percent Change | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TC (n = 1965, 1993, 1956) | -23.90 percentage change | Standard Deviation 17.45 |
| Participants Percent Change | Mean Percent Change From Baseline to Treatment in Lipid Parameters | HDL (n = 1805, 1782, 1705) | 2.06 percentage change | Standard Deviation 15.27 |
| Participants Percent Change | Mean Percent Change From Baseline to Treatment in Lipid Parameters | LDL (n = 1096, 1128, 1012) | -28.93 percentage change | Standard Deviation 23.52 |
Primary
Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
Time frame: Up to 14 days after the treatment discontinuation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Treated With VYTORIN | Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation | 5.72 Percentage of Participants |