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Combination Treatment of Ezetimibe and Simvastatin Safe and Effective: Presented at ISA

By Eurona Earl Tilley

KYOTO, JAPAN -- October 3, 2003 -- The combined administration of ezetimibe 10 mg/dL and simvastatin 5 mg to 80 mg/dL is well tolerated and effective in allowing patients with primary hypercholesterolaemia to attain the recommended low-density lipoprotein (LDL) cholesterol levels, according to a 48-week extension study.

Luis Masana, MD, Universitat Rovira, Virgili, Spain, presented the findings here October 1^st at the 13^th International Symposium on Atherosclerosis. The investigation included 433 patients who had not achieved a satisfactory lipid profile on 6 or more weeks of simvastatin treatment alone.

The subject demographics included comparable lipid values – LDL cholesterol 3.5 mmol/L, high-density lipoprotein (HDL) 1.3 mmol/L, total cholesterol 5.6 mmol/L, and mean triglyceride 1.7 mmol/L. The baseline age was approximately 60 years. Forty-three percent were women and 57% were men.

In addition to their current statin regiment, 25% received a placebo, and the others ezetimibe 10 mg/dL.

Dr. Masana explained that ezetimibe is a cholesterol absorption inhibitor that blocks the transport of dietary and biliary cholesterol across the intestinal wall. Ezetimibe does not affect the absorption of bile acids, fatty acids, fat-soluble vitamins, or triglycerides. It works as a complement to statins, which inhibit cholesterol synthesis in the liver.

Patients were evaluated for changes in lipid levels from baseline. Participants who received ezetimibe in addition to their regular statin regiment experienced a 24% reduction in LDL levels, 2% increase in HDL levels, and 21% reduction in non-HDL, a 16% reduction in total cholesterol, and an 8% reduction in triglycerides. In contrast, the placebo group experienced a 3% increase in LDL, a 1% decrease in HDL, a 4% increase in non-HDL, a 3% increase in total cholesterol, and a 5% increase in triglycerides.

Both groups had similar rates of adverse effects. Adverse events occurred in 72% of the placebo group and 75% of the ezetimibe group. In addition, 17% of the placebo group and 12% of the ezetimibe group experienced a serious adverse event. Ten percent and 7% of the placebo and ezetimibe groups respectively had to discontinue taking medication due to the occurrence of adverse effects.

Dr. Masana concluded that the co-administration of ezetimibe and statins provides superior LDL lowering efficacy to statins alone. This drug combination is well tolerated and has a safely profile similar to statin administration alone.

He said that medical professionals should consider this as a therapeutic option for patients with hypercholesterolaemia who require further LDL reductions.


[Study title: Long-term Safety and Efficacy of Ezetimibe Added to Ongoing Simvastatin Treatment. Abstract 3P]

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