Published in:
01-03-2010 | Original Research Article
Efficacy and Safety of Ezetimibe for Japanese Patients with Dyslipidaemia
The ESSENTIAL Study
Published in: Clinical Drug Investigation | Issue 3/2010
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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 10mg/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 10mg/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 10mg/day (n = 7) or rosuvastatin 2.5mg/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 (r = 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.