Hypercholesterolemia
Conditions
Brief summary
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels \<100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.
Interventions
DRUGEzetimibe
Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants in whom LDL-cholesterol target levels have not been achieved. * Participants in whom a decision has been made by the physician to initiate treatment with ezetimibe (longitudinal analyses). The treatment decision will be made prior to and independent from inclusion of participants into this study. \- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.
Exclusion criteria
* Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe. * In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial. * Previous and ongoing treatment with ezetimibe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | Up to 12 months | Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in TC at Month 12 | Baseline and Month 12 |
| Change From Baseline in LDL-C at Month 3 | Baseline and Month 3 |
| Change From Baseline in LDL-C at Month 12 | Baseline and Month 12 |
| Change From Baseline in Total Cholesterol (TC) at Month 3 | Baseline and Month 3 |
| Change From Baseline in HDL-C at Month 12 | Baseline and Month 12 |
| Change From Baseline in Triglycerides (TG) at Month 3 | Baseline and Month 3 |
| Change From Baseline in TG at Month 12 | Baseline and Month 12 |
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | Baseline and Month 3 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen. | 1,682 |
| Total | 1,682 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 885 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 64.58 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Austria | 1682 participants |
| Sex/Gender, Customized Females | 655 Participants |
| Sex/Gender, Customized Males | 1003 Participants |
| Sex/Gender, Customized Not Reported | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,682 |
| serious Total, serious adverse events | 3 / 1,682 |
Outcome results
Primary
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level | 678 Participants |
Secondary
Change From Baseline in HDL-C at Month 12
Time frame: Baseline and Month 12
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in HDL-C at Month 12 | 4.0 mg/dL | 95% Confidence Interval 15.05 |
Secondary
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3
Time frame: Baseline and Month 3
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 | 2.8 mg/dL | 95% Confidence Interval 14.17 |
Secondary
Change From Baseline in LDL-C at Month 12
Time frame: Baseline and Month 12
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in LDL-C at Month 12 | -49.3 mg/dL | 95% Confidence Interval 26.64 |
Secondary
Change From Baseline in LDL-C at Month 3
Time frame: Baseline and Month 3
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in LDL-C at Month 3 | -41.7 mg/dL | 95% Confidence Interval 31.81 |
Secondary
Change From Baseline in TC at Month 12
Time frame: Baseline and Month 12
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in TC at Month 12 | -54.5 mg/dL | 95% Confidence Interval 37.62 |
Secondary
Change From Baseline in TG at Month 12
Time frame: Baseline and Month 12
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in TG at Month 12 | -43.9 mg/dL | 95% Confidence Interval 75.06 |
Secondary
Change From Baseline in Total Cholesterol (TC) at Month 3
Time frame: Baseline and Month 3
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Total Cholesterol (TC) at Month 3 | -46.6 mg/dL | 95% Confidence Interval 40.5 |
Secondary
Change From Baseline in Triglycerides (TG) at Month 3
Time frame: Baseline and Month 3
Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Change From Baseline in Triglycerides (TG) at Month 3 | -33.8 mg/dL | 95% Confidence Interval 82.51 |