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.
Sawayama
Yasunori
Y
Department of General Medicine, Kyushu University Hospital, Higashi-ku, Fukuoka, Japan.
Maeda
Shinji
S
Ohnishi
Hachiro
H
Hayashi
Shin
S
Hayashi
Jun
J
D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D001384:Azetidines / Q000008:administration & dosage* / Q000009:adverse effects; D002784:Cholesterol / Q000097:blood; D019963:Clinical Chemistry Tests / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination / Q000009:adverse effects; D050171:Dyslipidemias / Q000150:complications / Q000188:drug therapy*; D000069438:Ezetimibe; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000188:drug therapy; D008875:Middle Aged; D017035:Pravastatin / Q000008:administration & dosage; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D016903:Drug Monitoring
D000924:Anticholesteremic Agents; D001384:Azetidines; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D014280:Triglycerides; D000068718:Rosuvastatin Calcium; D002784:Cholesterol; D000069438:Ezetimibe; D017035:Pravastatin