The HDL Particle Protection Study

• Status: Completed
• Trial end date: 2017-05-14
• Target enrollment: 0
• Participant gender: All

Summary

Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level. However, atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a better reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is superior to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number and function (better anti-oxydant activity)

• Phase: Phase 4

Details

• Lead Sponsor: Hotel Dieu de France Hospital
• Collaborators: Nouvelle Société Française d'Athérosclérose; Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria: patient should have all of the 3 criteria:

1. Patient with diabetes mellitus, defined by at least 1 of the following:

Fasting glucose > 125 mg/dL confirmed on 2 occasions HbA1C > 6.5% Patients receiving any glucose lowering agent (oral or subcutaneous)

2. Lipid profile should have ALL of the following characteristics:

Triglycerides >150 mg/dL HDL <45 mg/dL LDL < 190 mg/dL

3. Lp(a) level < 30 mg/dL

Exclusion Criteria:

1. Patients with known coronary artery disease defined by at least one of the following:

• Prior myocardial infarction

• Prior PCI

• Prior CABG

• Known coronary stenosis > 50% on coronary angiography

• A non invasive study revealing myocardial ischemia (such as a stress test, a nuclear perfusion study or a stress echo)

2. Poor diabetic control defined by an HbA1c > 8.5% in the preceding 3 months

3. Patients with known diabetic retinopathy, nephropathy or neuropathy

4. Patients with a creatinin clearance < 75 ml/min as calculated by the Cockcroft-Gault equation

5. Patients who have received any lipid lowering therapy within 6 weeks prior to inclusion (statin, fibrates, ezetimibe, niacin, resin binding agent)

6. Patients with underlying malignancy or infection or inflammatory disease

7. Patients with SGPT or SGOT or CK > 2.5 times upper reference value

8. Patients allergic to statins or who experienced prior significant side effects with statins such as elevation of liver enzymes or CK > 2.5 upper reference value

9. Patients older than 80

10. Females who are premenopausal

11. Patients unable to give informed consent