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

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

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 Overview

• Status: Completed
• Conditions: Dyslipidemia; Hypercholesterolemia

• Study Type: Observational
• Enrollment (Actual): 3215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Ferrieres J, Dallongeville J, Rossignol M, Benichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2008
• Primary Completion (Actual): September 15, 2014
• Study Completion (Actual): September 15, 2014

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimated): August 11, 2011

Study Record Updates

• Last Update Posted (Actual): September 5, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 0653A-204

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis