Hypercholesterolemia
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.
Detailed description
Sampling method: invitation to the physician's patients.
Interventions
DRUGezetimibe
10 mg once daily
DRUGstatin
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Events | 4-6 weeks after the first visit | Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.) |
| Intensity of Adverse Events Reported | 4-6 weeks after the first visit | Intensity of adverse events reported after co-administration therapy |
| Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy | 4-6 weeks after the first visit | Achievement of LDL-C target levels as determined by physician |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Not Previously Treated subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy | 255 |
| Previously Treated With Statin subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy | 198 |
| Total | 453 |
Baseline characteristics
| Characteristic | Not Previously Treated | Previously Treated With Statin | Total |
|---|---|---|---|
| Age, Customized 20-30 years | 4 participants | 1 participants | 5 participants |
| Age, Customized 31-40 years | 21 participants | 9 participants | 30 participants |
| Age, Customized 41-50 years | 69 participants | 57 participants | 126 participants |
| Age, Customized 51-60 years | 108 participants | 81 participants | 189 participants |
| Age, Customized >61 years | 53 participants | 50 participants | 103 participants |
| Region of Enrollment Indonesia | 255 participants | 198 participants | 453 participants |
| Sex: Female, Male Female | 106 Participants | 79 Participants | 185 Participants |
| Sex: Female, Male Male | 149 Participants | 119 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 255 | 0 / 198 |
| serious Total, serious adverse events | 0 / 255 | 0 / 198 |
Outcome results
Primary
Intensity of Adverse Events Reported
Intensity of adverse events reported after co-administration therapy
Time frame: 4-6 weeks after the first visit
Population: All participants enrolled
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Not Previously Treated | Intensity of Adverse Events Reported | Mild | 1 Participants |
| Not Previously Treated | Intensity of Adverse Events Reported | Moderate | 0 Participants |
| Not Previously Treated | Intensity of Adverse Events Reported | Severe | 0 Participants |
| Previously Treated With Statin | Intensity of Adverse Events Reported | Mild | 1 Participants |
| Previously Treated With Statin | Intensity of Adverse Events Reported | Moderate | 0 Participants |
| Previously Treated With Statin | Intensity of Adverse Events Reported | Severe | 0 Participants |
Primary
Number of Participants Reporting Adverse Events
Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)
Time frame: 4-6 weeks after the first visit
Population: All participants enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Not Previously Treated | Number of Participants Reporting Adverse Events | 1 Participants |
| Previously Treated With Statin | Number of Participants Reporting Adverse Events | 1 Participants |
Primary
Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy
Achievement of LDL-C target levels as determined by physician
Time frame: 4-6 weeks after the first visit
Population: All patients enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Not Previously Treated | Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy | 101 Participants |
| Previously Treated With Statin | Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy | 106 Participants |