A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)

Study Overview
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Brief Summary
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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.

Official Title
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Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®

Conditions
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Dyslipidemia, Hypercholesterolemia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ezetimibe monotherapy without prior treatment<br>Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | |
| Ezetimibe monotherpay with prior treatment<br>Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®). | |
| Ezetimibe plus statin<br>Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin. | |
| Ezetimibe/simvastatin<br>Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Month 12 | 
| 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. | At enrollment (baseline) | 
| 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. | up to 48 months | 
| 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. | up to 48 months | 
| 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. | up to 48 months |