Ezetimibe in Patients Hypo-responsive to Statins
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Cholesterol; Coronary Artery Disease
Intervention: Ezetimibe (Drug); Atorvastatin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Ori Ben-Yehuda, MD, Principal Investigator, Affiliation: UCSD
Summary
Response to statin therapy for elevated low density lipoprotein is variable and may be
influenced by cholesterol absorption. This study will evaluate whether combination therapy
with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less
than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin
20 mg daily).
Clinical Details
Official title: Atorvastatin vs. Atorvastatin/Ezetimibe in Patients With Hypo-response to Initial Dose Statin Therapy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: LDL-C reduction
Secondary outcome: LDL-C reduction as well as changes in TG, HDL, and non-HDL Cholesterol.
Detailed description:
Specific Aim 1 To identify a patient population seen in the UCSD general internal medicine
and cardiology subspecialty clinics as well as referrals from community physicians who are
hyporesponsive to statin therapy (defined as an initial LDL reduction of <25% in response to
10mg of atorvastatin or 20mg of simvastatin- expected mean reduction is 35% - 37% for
starting dose simvastatin and atorvastatin).
Specific Aim 2 To test the hypothesis, with a prospective study, that a hyporesponse to
statin therapy may be related to increased cholesterol absorption, and that this
hyporesponse may be overcome by the addition of ezetimibe, a specific cholesterol absorption
inhibitor.
Specific Aim 3 To evaluate whether patients with less than 25% LDL reduction on 10 mg of
atorvastatin (or 20 mg of simvastatin) would achieve significantly greater LDL reduction
with combination therapy (atorvastatin/ezetimibe) than with statin dose titration (using
atorvastatin).
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients will need to have an LDL-C level of 130 mg/dl or greater without
treatment.
- They must have demonstrated an initial LDL-C reduction of less than 25% on 10 mg of
atorvastatin or 20 mg of simvastatin.
- Eligible patients will be those deemed by their physicians to be eligible for lipid
lowering therapy with a statin and to have stable CAD, CAD equivalent per NCEP
guidelines, or Framingham risk of 10-20%.
Exclusion Criteria:
- Recent (<3 months) diagnosis of Acute Coronary Syndromes due to ethical
considerations [10].
- Pregnant patients, those planning to become pregnant, or those who are breast
feeding, those with liver disease, history allergic reaction to any agent used in the
trial, history of myositis, myopathy, pancreatitis, hypertriglyceridemia (TG > 400
mg/dL), history of significant alcohol or drug abuse, history of organ
transplantation, or patient refusal.
Locations and Contacts
UCSD Medical Center in Hillcrest Clinical Trials Facility, San Diego, California 92103, United States
Additional Information
Starting date: September 2009
Last updated: August 24, 2009
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