Dyslipidemia, Hyperlipidemia, Mixed Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, Dyslipidemia, Niacin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Combination lipid therapy, Lovastatin
Brief summary
The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Detailed description
Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Interventions
DRUGNiacin Extended Release/Lovastatin
Sponsors
Kos Pharmaceuticals
In His Image
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years old with CAD or risk factors for CAD 2. under standard care at Family Medical Care of Tulsa 3. not at LDL goal per ATP III guidelines
Exclusion criteria
1. pregnancy/lactating 2. liver disease 3. allergies to statin or niacin 4. active peptic ulcer disease 5. previous treatment with combination therapy for dyslipidemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid parameter change at 3 and 6 months | — |
| Percent of patients achieving ATP III LDL goals at 3 and 6 months | — |
Countries
United States
Outcome results
None listed