Trial Outcomes & Findings for A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204) (NCT NCT01414192)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3215 participants

Primary outcome timeframe

up to 48 months

Results posted on

2024-09-05

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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 or ezetimide with simvastatin	Ezetimibe/Simvastatin Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Overall Study STARTED	490	575	424	1726
Overall Study COMPLETED	490	575	424	1726
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ezetimibe Monotherapy Without Prior Treatment n=490 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherpay With Prior Treatment n=575 Participants Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=424 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin n=1726 Participants Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).	Total n=3215 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 11.5 • n=5 Participants	63.3 years STANDARD_DEVIATION 9.7 • n=7 Participants	60.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	61.4 years STANDARD_DEVIATION 10.6 • n=4 Participants	61.5 years STANDARD_DEVIATION 10.7 • n=21 Participants
Sex: Female, Male Female	283 Participants n=5 Participants	284 Participants n=7 Participants	164 Participants n=5 Participants	728 Participants n=4 Participants	1459 Participants n=21 Participants
Sex: Female, Male Male	207 Participants n=5 Participants	291 Participants n=7 Participants	260 Participants n=5 Participants	998 Participants n=4 Participants	1756 Participants n=21 Participants

PRIMARY outcome

Timeframe: up to 48 months

Population: All participants with available data for endpoint.

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.

Outcome measures

Outcome measures
Measure	Ezetimibe Monotherapy Without Prior Treatment n=490 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherapy With Prior Treatment n=575 Participants Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=424 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin n=1726 Participants Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Rate of Cardiovascular (CV) Events	7.91 Events per 1000 patient-years Interval 3.95 to 14.14	10.79 Events per 1000 patient-years Interval 6.39 to 17.05	12.77 Events per 1000 patient-years Interval 7.3 to 20.74	13.4 Events per 1000 patient-years Interval 10.38 to 17.01

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ezetimibe Monotherapy Without Prior Treatment n=490 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherapy With Prior Treatment n=575 Participants Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=2150 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months	-22.4 Percentage Change Interval -51.6 to 8.2	-7.1 Percentage Change Interval -45.6 to 47.0	-30.7 Percentage Change Interval -63.6 to 16.1	—

SECONDARY outcome

Timeframe: At enrollment (baseline)

Population: All enrolled participants with available data

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.

Outcome measures

Outcome measures
Measure	Ezetimibe Monotherapy Without Prior Treatment n=490 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherapy With Prior Treatment n=575 Participants Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=424 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin n=1726 Participants Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Percentage of Participants With CV Risk Factors 0 risk factors	19.0 Percentage of Participants	15.0 Percentage of Participants	11.3 Percentage of Participants	11.2 Percentage of Participants
Percentage of Participants With CV Risk Factors 1 risk factor	29.0 Percentage of Participants	20.9 Percentage of Participants	19.6 Percentage of Participants	21.8 Percentage of Participants
Percentage of Participants With CV Risk Factors 2 risk factors	30.6 Percentage of Participants	34.1 Percentage of Participants	32.5 Percentage of Participants	31.9 Percentage of Participants
Percentage of Participants With CV Risk Factors 3 risk factors	16.3 Percentage of Participants	22.1 Percentage of Participants	25.9 Percentage of Participants	23.6 Percentage of Participants
Percentage of Participants With CV Risk Factors 4 risk factors	4.3 Percentage of Participants	7.0 Percentage of Participants	8.3 Percentage of Participants	9.2 Percentage of Participants
Percentage of Participants With CV Risk Factors 5 risk factors	0.8 Percentage of Participants	1.0 Percentage of Participants	2.4 Percentage of Participants	2.2 Percentage of Participants
Percentage of Participants With CV Risk Factors 6 risk factors	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.1 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.

Outcome measures

Outcome measures
Measure	Ezetimibe Monotherapy Without Prior Treatment n=1065 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherapy With Prior Treatment n=424 Participants Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=1726 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months 24 months (n=722; 380; 1563)	27.1 Percentage of Participants	14.3 Percentage of Participants	58.6 Percentage of Participants	—
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months 12 months (n=857; 446; 1755)	28.0 Percentage of Participants	14.6 Percentage of Participants	57.4 Percentage of Participants	—
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months 36 months (n=433; 248; 1025)	25.4 Percentage of Participants	14.5 Percentage of Participants	60.1 Percentage of Participants	—
Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months 48 months (n=203; 127; 437)	26.5 Percentage of Participants	16.6 Percentage of Participants	57.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: up to 48 months

Population: All enrolled participants with available data.

The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.

Outcome measures

Outcome measures
Measure	Ezetimibe Monotherapy Without Prior Treatment n=490 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherapy With Prior Treatment n=575 Participants Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=424 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin n=1726 Participants Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Percentage of Participants With at Least 1 Discontinuation of Study Drug	15.8 Percentage of Participants	13.4 Percentage of Participants	10.1 Percentage of Participants	11.8 Percentage of Participants

SECONDARY outcome

Timeframe: up to 48 months

Population: All enrolled participants with available data.

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.

Outcome measures

Outcome measures
Measure	Ezetimibe Monotherapy Without Prior Treatment n=378 Participants Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Monotherapy With Prior Treatment n=452 Participants Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).	Ezetimibe Plus Statin n=342 Participants Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin	Ezetimibe/Simvastatin n=1369 Participants Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
Mortality Rate	506.54 Deaths per 100,000 patient-years Interval 185.89 to 1102.53	689.66 Deaths per 100,000 patient-years Interval 330.72 to 1268.3	817.81 Deaths per 100,000 patient-years Interval 373.95 to 1552.46	761.77 Deaths per 100,000 patient-years Interval 524.37 to 1069.81

Adverse Events

Ezetimibe Monotherapy Without Prior Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ezetimibe Monotherapy With Prior Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ezetimibe Plus Statin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ezetimibe/Simvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place