Efficacy and safety of ezetimibe for Japanese patients with dyslipidaemia: The ESSENTIAL Study.

BACKGROUND

There are insufficient data available on the efficacy and safety of lipid-lowering therapy for patients with dyslipidaemia complicated by multiple metabolic abnormalities.

OBJECTIVE

This study aimed to examine the efficacy and safety of ezetimibe 10 mg/day administered to Japanese patients with dyslipidaemia.

METHODS

This was a prospective study carried out at Kyushu University Hospital, Fukuoka, Japan. In one group, ezetimibe 10 mg/day alone was given to 33 patients for 12 weeks. In the other two groups, ezetimibe was given with an HMG-CoA reductase inhibitor (statin) to 13 patients for 12 weeks: pravastatin 10 mg/day (n = 7) or rosuvastatin 2.5 mg/day (n = 6). The main outcome measure was the effect of ezetimibe on low-density lipoprotein cholesterol (LDL-C) and other lipid levels from baseline to 12 weeks.

RESULTS

After 12 weeks of treatment, all groups showed marked reductions in mean +/- SD LDL-C level (from 155.4 +/- 22.0 mg/dL at baseline to 118.0 +/- 28.1 mg/dL, i.e. -37.4 mg/dL; p < 0.001). The mean reduction in LDL-C level with ezetimibe monotherapy was significantly greater in patients with impaired LDL-C metabolism, glucose metabolism or hypertension than in those without such abnormalities (-21.0% vs -8.4%, p < 0.01; -22.7% vs -9.5%, p < 0.05; and -22.5% vs -5.9%, p < 0.05; respectively). The reduction in LDL-C levels with ezetimibe monotherapy was also correlated with the number of metabolic abnormalities (rho = 0.426, p = 0.013).

CONCLUSIONS

Both ezetimibe monotherapy and combination therapy with ezetimibe and a statin were able to safely and effectively control LDL-C levels in Japanese patients with dyslipidaemia, including those with metabolic abnormalities.