Dyslipidemia, Hypercholesterolemia
Conditions
Brief summary
This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.
Interventions
None listed
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Resident of Continental France * Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®) * Incident treatment with ezetimibe at the time of recruitment into the study
Exclusion criteria
* Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence * Participating in a clinical trial * Unable to read the information letter in French and/or unable to participate in the telephone interview in French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Cardiovascular (CV) Events | up to 48 months | Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months | Baseline and Month 12 | LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively. |
| Percentage of Participants With CV Risk Factors | At enrollment (baseline) | Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group. |
| Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | up to 48 months | Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded. |
| Percentage of Participants With at Least 1 Discontinuation of Study Drug | up to 48 months | The percentage of participants who stopped study drug at least once during the study period was recorded and summarized. |
| Mortality Rate | up to 48 months | The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years. |
Participant flow
Recruitment details
Data was provided by French physicians for participants who were being administered Ezetrol® monotherapy, or Ezetrol® coadministered with a statin, or Inegy® (a fixed-dose combination of ezetimibe and simvastatin.
Pre-assignment details
All participants who met inclusion criteria and contributed to at least one type of follow-up data in the form of an interview or physician questionnaire were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe Monotherapy Without Prior Treatment Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | 490 |
| Ezetimibe Monotherpay With Prior Treatment Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | 575 |
| Ezetimibe Plus Statin Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin | 424 |
| Ezetimibe/Simvastatin Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). | 1,726 |
| Total | 3,215 |
Baseline characteristics
| Characteristic | Ezetimibe Monotherapy Without Prior Treatment | Ezetimibe Monotherpay With Prior Treatment | Ezetimibe Plus Statin | Ezetimibe/Simvastatin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 11.5 | 63.3 years STANDARD_DEVIATION 9.7 | 60.8 years STANDARD_DEVIATION 10.8 | 61.4 years STANDARD_DEVIATION 10.6 | 61.5 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 283 Participants | 284 Participants | 164 Participants | 728 Participants | 1459 Participants |
| Sex: Female, Male Male | 207 Participants | 291 Participants | 260 Participants | 998 Participants | 1756 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Rate of Cardiovascular (CV) Events
Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.
Time frame: up to 48 months
Population: All participants with available data for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe Monotherapy Without Prior Treatment | Rate of Cardiovascular (CV) Events | 7.91 Events per 1000 patient-years |
| Ezetimibe Monotherapy With Prior Treatment | Rate of Cardiovascular (CV) Events | 10.79 Events per 1000 patient-years |
| Ezetimibe Plus Statin | Rate of Cardiovascular (CV) Events | 12.77 Events per 1000 patient-years |
| Ezetimibe/Simvastatin | Rate of Cardiovascular (CV) Events | 13.4 Events per 1000 patient-years |
Secondary
Mortality Rate
The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.
Time frame: up to 48 months
Population: All enrolled participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe Monotherapy Without Prior Treatment | Mortality Rate | 506.54 Deaths per 100,000 patient-years |
| Ezetimibe Monotherapy With Prior Treatment | Mortality Rate | 689.66 Deaths per 100,000 patient-years |
| Ezetimibe Plus Statin | Mortality Rate | 817.81 Deaths per 100,000 patient-years |
| Ezetimibe/Simvastatin | Mortality Rate | 761.77 Deaths per 100,000 patient-years |
Secondary
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months
LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.
Time frame: Baseline and Month 12
Population: All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ezetimibe Monotherapy Without Prior Treatment | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months | -22.4 Percentage Change |
| Ezetimibe Monotherapy With Prior Treatment | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months | -7.1 Percentage Change |
| Ezetimibe Plus Statin | Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months | -30.7 Percentage Change |
Secondary
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months
Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.
Time frame: up to 48 months
Population: All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 48 months (n=203; 127; 437) | 26.5 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 24 months (n=722; 380; 1563) | 27.1 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 36 months (n=433; 248; 1025) | 25.4 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 12 months (n=857; 446; 1755) | 28.0 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 36 months (n=433; 248; 1025) | 14.5 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 48 months (n=203; 127; 437) | 16.6 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 12 months (n=857; 446; 1755) | 14.6 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 24 months (n=722; 380; 1563) | 14.3 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 48 months (n=203; 127; 437) | 57.0 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 24 months (n=722; 380; 1563) | 58.6 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 36 months (n=433; 248; 1025) | 60.1 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months | 12 months (n=857; 446; 1755) | 57.4 Percentage of Participants |
Secondary
Percentage of Participants With at Least 1 Discontinuation of Study Drug
The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.
Time frame: up to 48 months
Population: All enrolled participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With at Least 1 Discontinuation of Study Drug | 15.8 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With at Least 1 Discontinuation of Study Drug | 13.4 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With at Least 1 Discontinuation of Study Drug | 10.1 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With at Least 1 Discontinuation of Study Drug | 11.8 Percentage of Participants |
Secondary
Percentage of Participants With CV Risk Factors
Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.
Time frame: At enrollment (baseline)
Population: All enrolled participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 2 risk factors | 30.6 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 5 risk factors | 0.8 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 4 risk factors | 4.3 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 1 risk factor | 29.0 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 0 risk factors | 19.0 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 6 risk factors | 0.0 Percentage of Participants |
| Ezetimibe Monotherapy Without Prior Treatment | Percentage of Participants With CV Risk Factors | 3 risk factors | 16.3 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 1 risk factor | 20.9 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 2 risk factors | 34.1 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 3 risk factors | 22.1 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 4 risk factors | 7.0 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 5 risk factors | 1.0 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 6 risk factors | 0.0 Percentage of Participants |
| Ezetimibe Monotherapy With Prior Treatment | Percentage of Participants With CV Risk Factors | 0 risk factors | 15.0 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 5 risk factors | 2.4 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 2 risk factors | 32.5 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 1 risk factor | 19.6 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 6 risk factors | 0.0 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 0 risk factors | 11.3 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 4 risk factors | 8.3 Percentage of Participants |
| Ezetimibe Plus Statin | Percentage of Participants With CV Risk Factors | 3 risk factors | 25.9 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 4 risk factors | 9.2 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 0 risk factors | 11.2 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 5 risk factors | 2.2 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 2 risk factors | 31.9 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 1 risk factor | 21.8 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 6 risk factors | 0.1 Percentage of Participants |
| Ezetimibe/Simvastatin | Percentage of Participants With CV Risk Factors | 3 risk factors | 23.6 Percentage of Participants |