Benefit of Elevation of HDL-cholesterol/Triglyceride Lowering on Cardiovascular Outcomes in Women
Overview
- Phase
- Phase 4
- Intervention
- Niaspan
- Conditions
- Cardiovascular Outcomes
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- endothelial function
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides.
The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.
Investigators
Noel Bairey Merz
Director
Cedars-Sinai Medical Center
Eligibility Criteria
Inclusion Criteria
- •Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
- •Well-controlled diabetes with HbA1C \< 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
- •Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
Exclusion Criteria
- •History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) or surgery within previous 3 months
- •Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
- •Active or known gall bladder disease
- •Pregnant or nursing women
- •Significant comorbidity that precludes participation
- •Significant liver disease, active alcoholism, or LFT(liver function test) \>1.5x's ULN( upper limit of normal) at screening
- •Diabetes with Hg A1C(hemoglobin A1c) \< 7.5
- •PI perceived inability to comply with protocol
Arms & Interventions
Niaspan
Patients will be randomized to Niaspan 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of Niaspan will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.
Intervention: Niaspan
Control
patients will be randomized to placebo 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of placebo will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.
Intervention: Placebo
Outcomes
Primary Outcomes
endothelial function
Time Frame: 16 weeks