Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

Bronx VA Medical Center

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Drug: Ezetimibe 10 mg; Drug: Ezetimibe 5 mg

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00762229

VA---19-07-051

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Ezetimibe 10 mg

Active Comparator group

Description:

A whole ezetimibe 10 mg tablet

Treatment:

Drug: Ezetimibe 10 mg

Ezetimibe 5 mg

Experimental group

Description:

Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half

Treatment:

Drug: Ezetimibe 5 mg