Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Summary:
Background: There is a lot of interest in the function and role of HDL to prevent and
mitigate atherosclerosis in patients who are at or near LDLc targets. Statins have variable
effects on HDLc which are accentuated in patients with a low baseline HDLc. Higher doses of
statins are being used more commonly in practice based on newer outcomes studies which find
greater benefits of the higher doses compared to lower or standard doses. This study is
testing FDA approved dosages of two commonly used statin medications.
Design: The study is designed to examine the effects of 80mg simvastatin and 80mg
atorvastatin on HDLc concentrations. Serum will be saved for a hopeful collaborative effort
with investigators at the U. of Washington who are able to do more advanced testing of HDL
particle functionality. Based on the first 13 patients studied at Indiana University, the
effects of these statins on HDLc concentrations vary greatly. It is unknown what impact these
concentration changes have on the functionality of the particles however. A meta-analysis of
4 prospective trials published in JAMA in 2006 found that increasing HDLc with statins was
independently associated with regression of atherosclerosis as measured by intravascular
ultrasound.
Patients: Patients with low HDLc will be the primary population recruited. Exclusion criteria
include interacting medications, pregnancy, baseline hepatic disease or other illnesses which
would put patients at increased risk of statin side effects.
Phase:
Phase 4
Details
Lead Sponsor:
Oregon Health and Science University
Collaborators:
Indiana University Merck Sharp & Dohme Corp. Oregon State University