Hypercholesterolemia
Conditions
Keywords
Cholesterol, Ezetimibe
Brief summary
The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.
Interventions
DRUGEzetimibe 10 mg
Ezetimibe 10 mg daily for 4 weeks
DRUGEzetimibe 5 mg
Ezetimibe 5 mg daily for 4 weeks, formulated as a 10 mg tablet split in half
Sponsors
Bronx VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects receiving ezetimibe 10 mg * Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%): * 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months * 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months * 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months * Patients willing and able to provide signed informed consent
Exclusion criteria
* Patients not receiving ezetimibe * Patients receiving ezetimibe 5 milligrams * Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months * Cancer undergoing active treatment * Participation in any clinical study within the last 30 days * Drug addiction or alcohol abuse within the past 6 months * Patients unwilling or unable to provide informed consent * Patients with poor compliance * Women of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | 4 weeks | LDL cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol | 4 weeks | Total cholesterol fasting |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from themedical, cardiology and lipid clinics from Spetember 2007 through April 2008.
Pre-assignment details
The drug was prescribed once daily. No patients were excluded after randomization
Participants by arm
| Arm | Count |
|---|---|
| Ezetimibe 10 mg A whole ezetimibe 10 mg tablet | 15 |
| Ezetimibe 5 mg Ezetimibe 5 mg, | 24 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not recveive intervention | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Ezetimibe 5 mg | Ezetimibe 10 mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 5 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 10 Participants | 19 Participants |
| Age Continuous | 72 years STANDARD_DEVIATION 10.1 | 69 years STANDARD_DEVIATION 9.2 | 70.5 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 24 participants | 15 participants | 39 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 23 Participants | 15 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 23 |
| serious Total, serious adverse events | 0 / 15 | 0 / 23 |
Outcome results
Primary
LDL Cholesterol
LDL cholesterol
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe 10 mg | LDL Cholesterol | 103 mg/dL | Standard Deviation 24 |
| Ezetimibe 5 mg | LDL Cholesterol | 97 mg/dL | Standard Deviation 38 |
Secondary
Total Cholesterol
Total cholesterol fasting
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ezetimibe 10 mg | Total Cholesterol | 180 mg/dL | Standard Deviation 35 |
| Ezetimibe 5 mg | Total Cholesterol | 167 mg/dL | Standard Deviation 48 |