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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: Indiana University; Merck Sharp & Dohme Corp.; Oregon State University
• Treatments: Atorvastatin; Atorvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• 18 years of age or older

• Screening visit HDL-c cholesterol < 40 mg/dL (men) or < 50 mg/dL (women)

• Screening visit LDL-c or non-HDL-c (for patients with TG 200-500 mg/dL) in range requiring therapy based on National Cholesterol Education Program (NCEP) guidelines

• Identifiable primary care provider

• Working phone number for follow-up

Exclusion Criteria:

• Age < 18 years

• Any unstable coronary disease (angina) at the screening visit or any acute coronary syndrome < 6 months prior to first study visit

• Screening TG > 750 mg/dL

• Known allergy or contraindication to atorvastatin or simvastatin

• Known HIV/AIDS diagnosis

• Screening alanine aminotransferase (ALT) > 3 times upper lab reference range (ULR)

• Known history or diagnosis of clinical hepatic failure (example: variceal bleeding, ascites, INR>1.3)

• Self-reported weekly alcohol intake of > 2 drinks per day on average (e.g. > 14 drinks/week)

• Self- reported pregnancy or current breastfeeding

• Use of a fibrate or niacin product or any other drug listed in the Zocor or Lipitor product package insert at a dose which causes a significant drug interaction

• Anticipated inability to complete the 4-visit study timeline for any reason (expected prolonged travel, extenuating medical needs, etc.)

• Active participation in another research protocol which would interfere with this trial