Trial Outcomes & Findings for Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1) (NCT NCT01381679)

NCT ID: NCT01381679

Last Updated: 2022-02-09

Results Overview

Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively

• Recruitment status: COMPLETED
• Target enrollment: 1682 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	All Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Overall Study STARTED	1682
Overall Study COMPLETED	794
Overall Study NOT COMPLETED	888

Reasons for withdrawal

Measure	All Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	885

Baseline Characteristics

Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)

Baseline characteristics by cohort

Measure	All Participants n=1682 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Age, Continuous	64.58 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex/Gender, Customized Males	1003 Participants n=5 Participants
Sex/Gender, Customized Females	655 Participants n=5 Participants
Sex/Gender, Customized Not Reported	24 Participants n=5 Participants
Region of Enrollment Austria	1682 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively

Outcome measures

Measure	All Participants n=1682 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level	678 Participants

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.

Outcome measures

Measure	All Participants n=782 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in Total Cholesterol (TC) at Month 3	-46.6 mg/dL 95% Confidence Interval 40.5 • Interval -49.4 to -43.8

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.

Outcome measures

Measure	All Participants n=782 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in TC at Month 12	-54.5 mg/dL 95% Confidence Interval 37.62 • Interval -57.7 to -51.3

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.

Outcome measures

Measure	All Participants n=750 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in LDL-C at Month 3	-41.7 mg/dL 95% Confidence Interval 31.81 • Interval -44.2 to -39.3

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.

Outcome measures

Measure	All Participants n=750 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in LDL-C at Month 12	-49.3 mg/dL 95% Confidence Interval 26.64 • Interval -51.9 to -46.7

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.

Outcome measures

Measure	All Participants n=774 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3	2.8 mg/dL 95% Confidence Interval 14.17 • Interval 2.0 to 3.6

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.

Outcome measures

Measure	All Participants n=774 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in HDL-C at Month 12	4.0 mg/dL 95% Confidence Interval 15.05 • Interval 3.1 to 5.0

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.

Outcome measures

Measure	All Participants n=756 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in Triglycerides (TG) at Month 3	-33.8 mg/dL 95% Confidence Interval 82.51 • Interval -41.1 to -26.6

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.

Outcome measures

Measure	All Participants n=756 Participants Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Change From Baseline in TG at Month 12	-43.9 mg/dL 95% Confidence Interval 75.06 • Interval -51.5 to -36.4

Adverse Events

All Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=1682 participants at risk Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
Hepatobiliary disorders Cholecystitis	0.06% 1/1682 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.06% 1/1682 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Neoplasm	0.06% 1/1682 • Number of events 1 • 12 months

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: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60