A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

Condition(s) targeted: Hyperlipidemia

Intervention: simvastatin 20 mg/ezetimibe (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Frederick F Samaha, M.D., Principal Investigator, Affiliation: Philadelphia VAMC

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.

Official title: A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: LDL cholesterol

Secondary outcome:

Other lipid measures

Safety and tolerability

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Starting date: April 2006
Ending date: November 2007
Last updated: November 30, 2007