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

Organon and Co3,215 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,215

Conditions

Dyslipidemia Hypercholesterolemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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)

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

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.

Data from ClinicalTrials.gov

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