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 (LOCUST)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: simvastatin 20 mg/ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566267

MIRB Number: 00887

PROM # 0025

00887

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 1 patient group

2

Experimental group

Description:

Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg

Treatment:

Drug: simvastatin 20 mg/ezetimibe