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Ezetimibe Plus Simvastatin Safely Improves Lipid Profile

Combination of the novel agent ezetimibe with simvastatin for treatment of primary hypercholesterolaemia is well tolerated and comparable to statin treatment alone.

Clinicians believe that combination therapy with lipid-lowering agents which act via two complementary pathways might allow more patients to achieve recommended cholesterol goals. Ezetimibe is the first in a new class of potential lipid-management drugs known as cholesterol absorption inhibitors.

Researchers at the Chicago Center for Clinical Research, Chicago, Illinois, United States, assessed the efficacy and safety of ezetimibe when administered with simvastatin in patients with primary hypercholesterolaemia.

After dietary stabilisation, a 2 to 12-week washout and a 4-week single-blind, placebo lead-in period, patients with baseline low-density lipoprotein cholesterol of 145 to 250 mg/dL (3.8-6.5 mmol/L) and triglycerides below 350 mg/dL (9.1 mmol/L) were randomised to 10 different daily regimens for 12 consecutive weeks: ezetimibe 10 mg, simvastatin 10, 20, 40 or 80 mg, ezetimibe 10 mg plus simvastatin 10, 20, 40 or 80 mg, or placebo.

The primary efficacy variable was the percentage reduction from baseline to end point in direct low-density lipoprotein cholesterol for the pooled ezetimibe plus simvastatin groups versus pooled simvastatin groups.

Ezetimibe plus simvastatin significantly improved low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides compared with simvastatin alone.

Ezetimibe plus simvastatin (pooled doses) provided an incremental 13.8% low-density lipoprotein cholesterol reduction, a 2.4% high-density lipoprotein cholesterol increase and a 7.5% triglycerides reduction compared with pooled simvastatin alone.

Ezetimibe and simvastatin given together reduced low-density lipoprotein cholesterol by 44 to 57%, reduced triglycerides by 20 to 28% and raised high-density lipoprotein cholesterol by 8 to 11%, depending on the simvastatin dose.

Ezetimibe 10 mg plus simvastatin 10 mg and simvastatin 80 mg alone each reduced low-density lipoprotein cholesterol by 44%.

The co-administration of ezetimibe with simvastatin was well tolerated. The safety profile of this combination was similar to both simvastatin and placebo.

When given with simvastatin, ezetimibe provided significant incremental reductions in low-density lipoprotein cholesterol and triglycerides, as well as increases in high-density lipoprotein cholesterol.
Journal of the American College of Cardiology 2002 18;40(12):2125-2134. "Ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia."

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