Purpose: Impaired lipid metabolism has yet to be controlled satisfactorily. We investigated the effect and safety of ezetimibe, which is an inhibitor of small intestinal cholesterol transporter, in dislipidemic patients. Methods: A total of 55 patients, including 22 males, received 10 mg of ezetimibe daily for 6 months as a single drug or in combination with statin. Data were collected before, and at three and six months after the start of ezetimibe. The data were analyzed by repeated measure analysis of variance, in which LDL-cholesterol (LDL-C), HDL-cholesterol or triglyceride (TG) was used as a dependent variable, and combinations of administration of statin, gender, and hypertension were used as between-subject covariates. Results: Only two factors showed significant effects: Ezetimibe lowered the mean LDL-C by 31 mg/dl at three months; also, it was 34 mg/dl lower with statin than without. This effect was additive, and no interaction was observed between any two factors. No significant change was found when HDL-cholesterol or triglyceride was used as dependent variable. Conclusion: Ezetimibe improved the dyslipidemic state by reducing LDL-C, displaying adequate tolerability and safety in high risk patients with diabetes and hypertension. We hope that ezetimibe could contribute to the reduction of cardiovascular events in Japan. Combined administration of ezetimibe and statin might be useful if ezetimibe alone is ineffective.
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