Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia
Brief summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety 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 EZETROL® In Usual Medical Practice
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation | Up to 14 days after treatment discontinuation | Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment. |
| Mean Percent Change From Baseline to Treatment in Lipid Parameters | Baseline to 4 weeks | The mean percent change from baseline to treatment in lipid parameters (total cholesterol \[TC\], low-density lipoprotein \[LDL\] cholesterol, high-density lipoprotein \[HDL\] cholesterol, triglycerides\[TG\]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters. |
| Overall Efficacy Evaluation of EZETROL® | Baseline to 4 weeks | Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EZETROL® 10 mg Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily. | 3,536 |
| Total | 3,536 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Participants for Efficacy Evaluation | Lack of treatment period (<28 days) | 106 |
| Participants for Efficacy Evaluation | No efficacy evaluation | 119 |
| Participants for Efficacy Evaluation | Unknown date of efficacy evaluation | 2 |
| Participants for Safety Evaluation | Duplicated participants | 22 |
| Participants for Safety Evaluation | Duplicated participants & off-label use | 1 |
| Participants for Safety Evaluation | Off-label use | 283 |
| Participants for Safety Evaluation | Treatment prior to date of contract | 8 |
| Participants for Safety Evaluation | Uncontracted participants | 4 |
| Participants for Safety Evaluation | Violation of inclusion criteria | 612 |
| Participants for Safety Evaluation | Violation of inclusions & off label use | 1 |
Baseline characteristics
| Characteristic | EZETROL® 10 mg |
|---|---|
| Age, Customized 20 ≤ age < 30 | 25 participants |
| Age, Customized 30 ≤ age < 40 | 186 participants |
| Age, Customized 40 ≤ age < 50 | 682 participants |
| Age, Customized 50 ≤ age < 60 | 1091 participants |
| Age, Customized 60 ≤ age < 70 | 1023 participants |
| Age, Customized 70 ≤ age < 80 | 451 participants |
| Age, Customized 80 ≤ age < 90 | 72 participants |
| Age, Customized age < 20 | 4 participants |
| Age, Customized age ≥ 90 | 2 participants |
| Sex: Female, Male Female | 1861 Participants |
| Sex: Female, Male Male | 1675 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 5 / 1,135 | 3 / 1,039 | 0 / 766 | 0 / 154 | 29 / 375 |
| serious Total, serious adverse events | 0 / 67 | 3 / 1,135 | 18 / 1,039 | 9 / 766 | 4 / 154 | 2 / 375 |
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 \[TC\], low-density lipoprotein \[LDL\] cholesterol, high-density lipoprotein \[HDL\] cholesterol, triglycerides\[TG\]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.
Time frame: Baseline to 4 weeks
Population: 3,309 subjects were analyzed for the efficacy~evaluation; 227 of the enrolled subjects did not complete the study and were excluded
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EZETROL® 10 mg | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TC (n = 2439) | -21.23 percentage of change | Standard Deviation 21.16 |
| EZETROL® 10 mg | Mean Percent Change From Baseline to Treatment in Lipid Parameters | HDL (n = 1928) | 3.47 percentage of change | Standard Deviation 19.81 |
| EZETROL® 10 mg | Mean Percent Change From Baseline to Treatment in Lipid Parameters | LDL (n = 1774) | -24.06 percentage of change | Standard Deviation 33.49 |
| EZETROL® 10 mg | Mean Percent Change From Baseline to Treatment in Lipid Parameters | TG ( n = 2083) | -10.37 percentage of change | Standard Deviation 45.05 |
Primary
Overall Efficacy Evaluation of EZETROL®
Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.
Time frame: Baseline to 4 weeks
Population: 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EZETROL® 10 mg | Overall Efficacy Evaluation of EZETROL® | Improved | 3029 participants |
| EZETROL® 10 mg | Overall Efficacy Evaluation of EZETROL® | Unchanged | 241 participants |
| EZETROL® 10 mg | Overall Efficacy Evaluation of EZETROL® | Worsened | 39 participants |
| EZETROL® 10 mg | Overall Efficacy Evaluation of EZETROL® | Total | 3309 participants |
Primary
Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Time frame: Up to 14 days after treatment discontinuation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EZETROL® 10 mg | Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation | 257 participants |