Hyperlipidemia
Conditions
Brief summary
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.
Interventions
DRUGsimvastatin 20 mg/ezetimibe
see protocol
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Moderately obese with hyperlipidemia
Exclusion criteria
* Recent unstable heart or lung condition * Current use of other lipid modifying drugs * Hepatic disease * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol | 8 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Other lipid measures | 8 weeks of treatment |
| Safety and tolerability | 8 weeks treatment |
Outcome results
None listed