Ezetimibe in Patients Hypo-responsive to Statins

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Aug 24, 2009

Keywords

ClinConnect Summary

Specific Aim 1 To identify a patient population seen in the University of California, San Diego 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 ...

Gender

ALL

Eligibility 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.