Cardiovascular Outcomes
Conditions
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.
Interventions
DRUGNiaspan
See Arm Description
DRUGPlacebo
See Arm Description
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endothelial function | 16 weeks |
Countries
United States
Outcome results
None listed